Treatment Trials

73 Clinical Trials for Various Conditions

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RECRUITING
Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 2)
Description

Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from H coil combined with cognitive training for improving white matter integrity.

Conditions
RECRUITING
Examining the Effects of Theta Burst TMS on Brain Connectivity and Balance Ability in Older Adults With Balance Problems
Description

The goal of this study is to learn if manipulating the brain using magnets works to treat balance impairment, a major cause of falls, in older adults with balance problems. The technique to manipulate the brain using magnets is known as transcranial magnetic stimulation or TMS. The main questions this study aims to answer are: * How does TMS change communication between brain areas? * Does TMS improve balance ability in older adults with balance problems? Researchers will compare the TMS group to a placebo group to see if manipulating the brain using magnets works to treat balance impairment. Participants will: * Receive TMS or placebo stimulation for 4 weeks. * Visit the laboratory for checkups and tests 3 times.

RECRUITING
Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 1)
Description

Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from H coil for improving white matter integrity.

Conditions
RECRUITING
Brain Connectivity Changes With Spinal Cord Stimulation and Treatment of Chronic Pain: A Resting State NIRS/EEG Study
Description

This study aims to assess how use of spinal cord stimulation for the treatment of chronic pain impacts brain structure and function. The investigators will use a non-invasive neuroimaging technique called resting state Near Infrared Spectroscopy and Electroencephalography (rs-fNIRS/EEG). The investigators will enroll Veterans who are currently receiving care at the Medical Center and who are either long term users of SCS for the treatment of their chronic pain or being evaluated for use of SCS to treat their pain.

RECRUITING
Efficacy of Reading Intervention on the Brain Connectivity in Autism
Description

The overarching goal of this proposal is to test the impact of a comprehensive reading intervention program (Visualizing and Verbalizing) on changing the neurobiological mechanisms underlying reading comprehension deficits in children with autism spectrum disorders (ASD). To this end, the investigators will test a group of children with ASD and NT control participants who share common characteristic of average level decoding along with below average reading comprehension. Inclusion of an additional NT group that does not have any reading comprehension deficit will provide another control for additional comparisons.

COMPLETED
Study of Structural and Functional Brain Connectivity Changes in ALS (CoALS-II)
Description

This study will try to understand the difference in brain structure between ALS patients and healthy people of similar age. ALS is a condition affecting the nervous system with disruption of the brain networks. This study aims to understand these disruptions and determine their significance in ALS.

RECRUITING
Brain Connectivity Patterns in Chronic Temporomandibular Joint Disorders
Description

This study addresses the timely problem of painful temporomandibular disorders (TMD), the most common cause of orofacial pain second only to tooth pain. Findings from previous studies suggest that dysregulation of connectivity within specific brain circuits is part of chronic pain pathophysiology. This study will identify connectivity patterns within those brain circuits as potential signatures for pain- related disability in chronic TMD pain participants. New knowledge regarding these brain connectivity patterns is expected to be significant because it will support improved phenotyping of this heterogeneous participant population. It is also expected that this finding can potentially be extrapolated to other chronic pain conditions, such as back pain, migraine headache, and fibromyalgia that are frequently comorbid conditions in chronic TMD participants.

COMPLETED
Feedback, Motor Sequence Learning, and Brain Connectivity
Description

Feedback delivered during motor practice can help promote motor skill learning, enhance confidence, and alter brain connectivity. However, the optimal way to provide feedback to promote learning, confidence and brain connectivity is unknown. This project will study how the feedback that is provided during practice of a movement skill can help people learn and build confidence and whether these correspond to changes in brain function. The investigators will measure motor skill performance, confidence, and resting state brain connectivity before and after a session of motor practice.

Conditions
COMPLETED
Evaluation of Changes in Brain Connectivity After Tumor Resection
Description

This study is being done to see the changes in structural and functional connectivity that happen in the brain of patients undergoing brain tumor surgery.

Conditions
COMPLETED
5HT2CR Balance in Brain Connectivity in Cocaine Dependence
Description

This project will evaluate the role of the 5-HT2CR:5-HT2AR balance in impulsive action and cue reactivity in cocaine-dependent subjects as compared to non-drug using controls.

RECRUITING
Brain Connectivity in Depression
Description

This study originally included 140 subjects with medication-refractory depression undergoing 10 Hz transcranial magnetic stimulation (10Hz-TMS) to the left dorsal lateral prefrontal cortex (DLPFC), with the goal of having 60 completers with good quality data. Subjects were recruited from the TMS clinics at Beth Israel Deaconess Medical Center, Brigham \& Women's Hospital, and Butler Hospital. Subjects underwent an hour-long MRI scanning session, an optional DNA-sample collection, up to three 20 minute neuronavigation sessions for marking the site of TMS stimulation, questionnaires, and a behavioral testing battery before and after their TMS treatment course. The task battery included the Emotion Conflict Resolution (ECR) task, Multi-Source Interference Task (MSIT), War Game (Gambling) task, and Associative Learning with Reversal task. Subjects' scores on the Quick Inventory of Depressive Symptomatology (QIDS) and Beck Depression Inventory (BDI) were assessed before and after the TMS course. MRI data was utilized to identify brain regions whose connectivity to the stimulation site co-varies with the aforementioned measures of symptom improvement. This was the only study group until August 30, 2022, and the primary outcome was analyzed for the 10Hz-TMS group. Due to changes in clinical standard of care from 10Hz-TMS to a newer version of TMS termed intermittent theta burst (iTBS), in September 2022 a second group was added to include patients receiving this new form of TMS. This second group included another 100 patients with medication-refractory depression undergoing iTBS to the left dorsal lateral prefrontal cortex (DLPFC), with the intent to have 80 completers. Massachusetts General Hospital was added as a data collection site in lieu of Butler Hospital. Subjects will undergo an hour-long MRI scanning session, up to three 20 minute neuronavigation sessions for marking the site of TMS stimulation, questionnaires, and a behavioral testing battery before and after their TMS treatment course. The task battery will included the Emotion Conflict Resolution (ECR) task, Multi-Source Interference Task (MSIT), Penn Emotion Recognition Test, the Suicide/Death Implicit Association Test, and Associative Learning with Reversal task. Subjects' scores on the Beck Depression Inventory (BDI) were assessed before and after the TMS course. MRI data will be utilized to identify brain regions whose connectivity to the stimulation site co-varies with the aforementioned measures of symptom improvement. Due to a higher dropout rate than anticipated, in March of 2025 an amendment was added to include an additional 20 subjects in the second group's enrollment goal to increase the likelihood of achieving 80 completers.

Conditions
COMPLETED
Investigating NeuroinflammaTion UnderlyIng Postoperative Brain Connectivity Changes, POCD, Delirium in Older Adults
Description

(From NIH reporter) Each year \>16 million older Americans undergo anesthesia and surgery, and up to 40% of these patients develop postoperative cognitive dysfunction (POCD), a syndrome of postoperative thinking and memory deficits. Although distinct from delirium, POCD (like delirium) is associated with decreased quality of life, long term cognitive decline, early retirement, increased mortality, and a possible increased risk for developing dementia such as Alzheimer's disease. Understanding the etiology of POCD will likely help promote strategies to treat and/or prevent it. A dominant theory holds that brain inflammation causes POCD, but little work has directly tested this theory in humans. The preliminary data of this team strongly suggest that there is significant postoperative neuro-inflammation in older adults who develop POCD. In this K76 award, the investigators will prospectively obtain pre- and post-operative cognitive testing, fMRI imaging and CSF samples in 200 surgical patients over age 65. This will allow the investigators to evaluate the role of specific neuro-inflammatory processes in POCD and its underlying brain connectivity changes.

Conditions
COMPLETED
Effects of Prism Adaption and rTMS on Brain Connectivity and Visual Representation
Description

Background: After a stroke, the balance between the two halves of the brain can be lost. This may cause people to lose the ability to perceive a side of space. This is called neglect. Having people wear prism glasses (called PA) can reduce neglect symptoms. Researchers want to find out more about how PA, and whether it restores the balance in the brain. Objective: To learn how prism adaption temporarily changes vision and connections in the brain. Eligibility: People ages 18 75 with brain damage of the right side of the brain from a stroke or other cause, leading to neglect. Healthy volunteers ages 18 75. Design: Participants will have 1 3 visits. Participants will be screened with a neurological exam. They may also have: Tests of thinking and vision Tests to see which eye and hand they prefer A pregnancy test All participants will: Answer questions about their personality, style of thinking, and beliefs. Do simple tasks on paper or computer Have magnetic resonance imaging. They will lie on a table that can slide in and out of a cylinder in a strong magnetic field. Participants will lie still or do computer tasks in the scanner. Participants may also have: Transcranial magnetic stimulation. A brief electrical current passes through a wire coil on the scalp. This creates a magnetic pulse that affects brain activity. Participants may be asked to tense certain muscles or perform simple actions or tasks. PA. They will sit in front of a board and point to a dot on it while they wear prism glasses that shift vision to the left or right....

COMPLETED
Effects of Sertraline on Brain Connectivity in Adolescents With OCD
Description

The investigators will examine how treatment with sertraline for 12 weeks impacts frontal-striatal-thalamic circuitry (FSTC) in this OCD sample.

Conditions
COMPLETED
Brain Connectivity and Response to Tai Chi in Geriatric Depression
Description

The purpose of this study is to evaluate the effects after up to 1 year of supervised weekly Tai-Chi-Chi versus Health Education and Wellness classes on reduction of depressive symptoms and improvement in resilience, health functioning, quality of life, cognition, sleep, fMRI neural correlates of working memory, and brain structure.

TERMINATED
Brain Connectivity and Mindfulness Training in Youth With Bipolar Disorder Not Otherwise Specified (NOS)
Description

The investigators propose to study 30 adolescents with bipolar disorder, not otherwise specified (BD NOS) and a family history of Bipolar I Disorder (BD) at baseline with rs-fMRI (functional magnetic resonance imaging) and functional connectivity (FC) analyses and compare data with previously acquired rs-fMRI and FC data from 20 age- and gender-matched healthy controls (HC). Subjects will then undergo a 12-week Mindfulness based stress reduction- teen (MBSR-T) intervention and be reassessed and rescanned. The intervention and scanning will take place in groups of 6-8 subjects/group/year over the 4 years. This proposal will be a natural progression of past research, while extending the investigators' expertise to include advanced FC analyses and mindfulness based interventions in youth with mood dysregulation. The investigators will also integrate trainees into the imaging and therapy components of this study, furthering our mission of mentoring the next generation of innovative researchers who will push the field forward.

COMPLETED
Brain Connectivity Supporting Language Recovery in Aphasia
Description

The integrity of structural connectivity supporting cortical regions in the left brain hemisphere is hypothesized to enable treatment-induced naming recovery in persons with language difficulties after a stroke (aphasia). The investigators will map whole brain connectivity (i.e., the brain connectome) to investigate the role of cortical connectivity in impairment (Aim 1) and recovery (Aim 2) in patients with aphasia undergoing treatment. This information will be used to construct personalized markers of anomia treatment outcome (Aim 3), which may serve as a guide for speech-language pathologists and neurologists when facing patient management decisions.

COMPLETED
Glutamate, Brain Connectivity and Duration of Untreated Psychosis
Description

The early stages of schizophrenia are associated with significant decreases in social and intellectual abilities, with more declines in chronic disease. Studies have identified relationships between duration of untreated psychosis (the duration between the onset of positive symptoms and treatment) and worse long term outcomes. However, the neurobiology of this phenomenon and its implications for response to antipsychotic medications remain poorly understood. Glutamatergic excess altering brain connectivity might provide an explanation for why those with longer duration of untreated psychosis have worse clinical outcomes. The investigators propose to use neuroimaging to study 67 first episode psychosis subjects before and after sixteen weeks of treatment with risperidone, a common antipsychotic. We will measure (1) glutamate and (2) structural and functional brain connectivity and test the hypotheses that glutamatergic abnormalities are present in first episode patients and that longer duration of untreated psychosis is associated with greater connectivity abnormalities that set the stage for poor response to treatment. 67 demographic-matched controls will also be recruited as a comparison group - healthy controls will not receive antipsychotic medication. The investigator's previous studies have made progress in the understanding of abnormalities in the glutamate system and brain connectivity in unmedicated patients with schizophrenia and modulation of these by antipsychotic medication. Two indices of glutamatergic dysfunction have been identified. While antipsychotic medications appear to modulate glutamate, the disturbance in the relationship between metabolites is not restored with treatment. In addition, the investigators found that both structural and functional connectivity abnormalities in unmedicated patients with schizophrenia predict patients' response to treatment. To the investigator's knowledge, no other group has performed a study that uses a combination of complementary neuroimaging techniques that will allow generating a broad characterization of glutamatergic function and brain connectivity in first episode psychosis and change with treatment. The results of the proposed studies could suggest a mechanism by which the duration of untreated psychosis is associated with poor treatment response which might lead to new interventions to target the illness.

COMPLETED
Brain Connectivity in Age-Related Macular Degeneration
Description

This study is to determine how cognitive deficits (e.g.,verbal fluency deficit) in patients with Age-Related Macular Degeneration (AMD) relate to specific aspects of brain and function. The study team will assess whether the "brain signatures" associated with specific cognitive deficits differ in older adults with and without AMD.

TERMINATED
The Role of Mid-Life Adiposity in Functional Brain Connectivity
Description

The purpose of the study is to use functional MRI (fMRI) to measure brain connectivity in middle-aged individuals with different levels of body fat. The ultimate goal of this research is to develop an early diagnostic tool for Alzheimer's disease.

COMPLETED
Noninvasive Study of Brain Connectivity With EEG and NIRS
Description

Background: - Different regions of the brain are activated when a person performs a task. Electroencephalograms (EEGs) and near-infrared spectroscopy (NIRS) are tests that detect changes in the brain. EEG looks at changes in electrical signals, and NIRS looks at changes in blood flow. These tests can detect local changes in brain activity in a safe and noninvasive way. Researchers want to study brain activity more closely by combining these tests. Objectives: - To use EEG and NIRS to study brain activity during specific tasks. Eligibility: - Healthy volunteers at least 18 years of age. Design: * Participants will be screened with a physical exam and medical history. * Participants will have between one and five testing sessions. Each session will be 1 to 2 hours long. The tests given at each session will be determined by the researchers. * Participants will have EEG and NIRS tests, given either separately or together. During these tests, participants will perform tasks of thinking and reasoning. * Participants may also complete optional tests of thinking and reasoning. These tests will be given on paper or on a computer.

COMPLETED
Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment
Description

The purpose of the proposed research is to study the potential changes in biomarkers of patients with neurodevelopmental disorders in response to treatment in clinical trials or in private psychiatry practice utilizing non-invasive psychophysiological measurements. The investigators plan to obtain psychophysical measurements throughout several periods of treatment.

COMPLETED
The Effects of Kuvan on Functional Brain Connectivity in Individuals With Phenylketonuria (PKU)
Description

The objective of the study is to determine whether Kuvan™ (sapropterin) improves the strength of the functional connectivity between brain regions in individuals with PKU.

Conditions
COMPLETED
Brain Connectivity Between Visual Input and Movement
Description

This study will explore how the areas in the brain are connected to link what people see to what they do; that is, how they use what they see to help guide their movements. The study uses functional magnetic resonance imaging (fMRI) to look at different areas in the brain while a person performs tasks in which both what they see (visual input) and what they do (their motor response) are related or unrelated. Healthy, right-handed normal volunteers who are 18 years of age or older may be eligible for this study. Candidates are screened with a medical history, neurological examination and MRI scan, if one has not been done within a year of entering the study. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The subject lies on a table that can slide in and out of the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking sounds that occur during scanning. The procedure lasts about 90 minutes, during which the subject is asked to lie still for up to 30 minutes at a time. Participants undergo fMRI for this 1-day study. fMRI differs from ordinary MRI in that the subject performs tasks during the scanning, allowing researchers to see brain changes that occur during performance of the activity. Before the scan, the subject is trained for the tasks, which include looking at shapes while following them with the fingers and looking at shapes without making finger movements. Following the testing, subjects have a second ordinary MRI scan.

RECRUITING
Resting State Changes Following Theta Burst Stimulation
Description

Transcranial magnetic stimulation (TMS) is increasingly being applied to effectively treat mental illness, however efforts to quantify the effects of TMS on the network architecture of the brain have largely been limited in scope and tied to specific neurologic and psychiatric disorders. The objective of the current work is to build and validate a whole-brain, domain-general model of brain connectivity changes following TMS, based on physical models of the current distribution at the cortex. PUBLIC HEALTH RELEVANCE: This work is relevant to public health because it will provide direct evidence that brain connectivity changes following neuromodulatory TMS vary as a function of the current density at the cortex, which can be used to predict psychiatric symptom change following neuromodulatory TMS.

COMPLETED
Brain Function in Performance of Motor Tasks
Description

This study will examine how the areas in the brain are connected when they are controlling two finger movements at the same time. It will look at how people use what they see to help guide two different movements. This ability, which is important in everyday life, can be a problem for patients with neurological problems. Healthy right-handed volunteers 18 years of age and older may be eligible for this study. Candidates are screened with a medical history, physical examination and magnetic resonance imaging (MRI) of the brain. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. The subject lies on a table that can slide in and out of the scanner, wearing earplugs to muffle loud noises that occur during the scanning. Participants undergo functional MRI (fMRI). This is a standard MRI that is done while the subject performs skilled finger tasks in response to instructions they see on a screen. Researchers localize brain areas which show activity changes while the tasks are performed. Before the test session begins, subjects complete a questionnaire and have an opportunity to practice the task. Subjects control the position of one or two cursors on a screen using one or two fingers. They perform tracking or pointing tasks according to what they see on the screen. During the single-task experiment only one task is presented on the screen. During the dual-task experiment, two tasks are presented on the screen. Subjects perform either the single-task or dual-task experiment, but not both. The fMRI lasts about 90 minutes, with subjects asked to lie still during the scan for up to 9 minutes at a time. After completing the fMRI, subjects are scheduled for a research electroencephalogram (EEG) and magnetoencephalogram (MEG). The test is done while the subject performs tasks so that researchers can learn about the timing of changes in activity in certain brain regions during performance of the same tasks done for the fMRI.

RECRUITING
Developing Brain, Impulsivity and Compulsivity
Description

Background: Impulsivity is acting 'without thinking.' Compulsivity is being overly inflexible. People vary in how impulsive or compulsive they are. Extreme versions of these behaviors play a role in mental disorders. Researchers want to study changes in the brain to learn more about these behaviors. Differences in genes may also play a role. Objective: To learn about genetic \& brain features that explain why levels of impulsivity and compulsivity vary across people. Eligibility: People ages 6 - 80 Design: Participants will be screened with a medical history and medical record review. Participants will talk about their mental and behavioral development. They may discuss topics like drug use and sexual activity. They will complete surveys about their compulsivity and impulsivity. Parents of child participants may also complete these surveys. Participants may take memory, attention, and thinking tests. They may give blood or saliva samples for gene studies. Participants may have a magnetic resonance imaging scan. It will take pictures of their brain. The scanner is shaped like a cylinder. Participants will lie on a table that slides in and out of the scanner. A coil will be placed over their head. They will lie still, watch a movie, and play a game. Participants may have a magnetoencephalography scan. It records brain activity. Participants will sit in a room. A "cone" of magnetic field detectors will be lowered around their head. They will rest and play a game. Participants may ask family members to join the study. Participants under age 25 may repeat these tests every 1-2 years until they turn 25 or until the study ends. For those over age 25, participation will last less than 1 month.

RECRUITING
Transcranial Magnetic Stimulation for BECTS
Description

Benign epilepsy with centrotemporal spikes (BECTS) is the most common pediatric epilepsy syndrome. Affected children typically have a mild seizure disorder, but yet have moderate difficulties with language, learning and attention that impact quality of life more than the seizures. Separate from the seizures, these children have very frequent abnormal activity in their brain known as interictal epileptiform discharges (IEDs, or spikes), which physicians currently do not treat. These IEDs arise near the motor cortex, a region in the brain that controls movement. In this study, the investigators will use a form of non-invasive brain stimulation called transcranial magnetic stimulation (TMS) to determine the impact of IEDs on brain regions important for language to investigate: (1) if treatment of IEDs could improve language; and (2) if brain stimulation may be a treatment option for children with epilepsy. Participating children will wear electroencephalogram (EEG) caps to measure brain activity. The investigators will use TMS to stimulate the brain region where the IEDs originate to measure how this region is connected to other brain regions. Children will then receive a special form of TMS called repetitive TMS (rTMS) that briefly reduces brain excitability. The study will measure if IEDs decrease and if brain connectivity changes after rTMS is applied. The investigators hypothesize that the IEDs cause language problems by increasing connectivity between the motor cortex and language regions. The investigators further hypothesize that rTMS will reduce the frequency of IEDs and also reduce connectivity between the motor and language region

ACTIVE_NOT_RECRUITING
Mind and Body Approaches to Pain Reduction in Youth With Migraine
Description

The overarching objective of this protocol is to identify and understand the neural and pain processing mechanisms by which youth with migraine improve in response to preventive treatment. The study design of this mechanistic investigation includes functional magnetic resonance imaging (fMRI), daily headache diaries, assessment of conditioned pain modulation via quantitative sensory testing, and validated psychometric assessments before and after the delivery of one of five treatments over an 8 week period \[cognitive behavioral therapy (CBT), biofeedback-assisted relaxation training (BART) and cognitive reappraisal (CR) training, amitriptyline, and placebo\]. We are examining both distinct and common pathways that may help explain the response to various preventive treatments, as well as potential predictors of outcome.

COMPLETED
Reliability of the Human Brain Connectome
Description

Background: - Magnetic resonance imaging (MRI) is used to investigate brain function. Researchers want to use MRI to better understand the function patterns and connections between brain regions in healthy people. This might help people with brain diseases in the future. Objectives: * To evaluate MRI methods performed twice on the same day. * To evaluate brain function using positron emission tomography (PET). Eligibility: - Healthy volunteers at least 18 years old. Design: * Visit 1: * Participants will be screened with medical history, physical exam, and interview about drug and alcohol use and psychiatric history. * They will give blood and urine samples. Their breath will be tested for alcohol and smoking. * Visit 2: * Participants will have urine collected. They will have MRI scans, some while resting, some while doing tasks on a computer. * The MRI scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder, with a coil over their head. Participants will get earplugs for loud noises. * Visit 3: * Participants will have urine collected. * A needle will guide a thin plastic tube (catheter) into each arm. The needle will be removed, leaving the catheter in the vein. * Participants will then have a PET scan. They will get the chemical 18FDG in the catheter. They will lie on a bed that slides in and out of the PET scanner, with a cap on their head. * Participants may have tests of memory, attention, concentration, and thinking. They may complete interviews, questionnaires, tests on paper or computer, and simple actions. * Participants will wear a device for 1 week between visits to measure activity and sleep.