Treatment Trials

1,547 Clinical Trials for Various Conditions

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RECRUITING
Impact of a Biophoton Therapy on Patients With Brain Disorders
Description

Previous clinical studies revealed that the newly developed biophoton therapy has been safe and effective in treating patients with Alzheimer's disease, dementia, stroke, traumatic brain injury, or Parkinson's disease. The current study is to confirm the previous clinical observation by conducting as a randomized, triple-blinded, placebo-controlled prospective intervention clinical research. About 80 patients with brain disorder (Alzheimer's disease, dementia, stroke, traumatic brain injury, Parkinson's disease) will participate in the intervention clinical study at the Tesla MedBed Center located in Butler, PA.

RECRUITING
SRS Compared with FSRS for Treatment of Intact Metastatic Brain Disease, FRACTIONATE Trial
Description

This phase II trial compares the effect of single fraction stereotactic radiosurgery to fractionated stereotactic radiosurgery for the treatment of patients with cancer that has spread to the brain (metastatic brain disease). Stereotactic radiosurgery (SRS) is a form of radiation therapy that focuses high-power energy on a small area of the body. This trial is being done to determine if single (one) fraction stereotactic radiosurgery is better than fractionated stereotactic radiosurgery or vice versa in controlling tumor and side effects in patients with tumors that have spread to the brain.

RECRUITING
PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease
Description

Background: About 5 million adults in the U.S. have Alzheimer s disease or another adult-onset neurodegenerative disorder. Many studies have found that inflammation in the brain contributes to these diseases. Researchers want to find a better way to measure this inflammation. Objective: To learn whether COX-1 and/or COX-2 is elevated in the brains of individuals with neurodegenerative brain disease compared to healthy volunteers. Eligibility: Adults age 18 years and older in good general health who have an adult-onset neurodegenerative dementia, such as AD, FTD, corticobasal syndrome, Huntington s disease, or MCI, ALS and healthy adult volunteers enrolled in protocols 01-M-0254 or 17-M-0181. Design: Participants will be screened with medical history, physical exam with vital signs, and lab tests. They will have a neuropsychological testing. Their heart function will be measured. Participants will have a magnetic resonance imaging (MRI) scan. The MRI scanner is a metal tube surrounded by a strong magnetic field. Participants will lie on a table that slides in and out of the tube. The machine makes noise. Participants will get earplugs. Participants will have 2 PET scans. They will be injected with the study drugs through an intravenous catheter placed in an arm vein. The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. A plastic mask will be molded to their head to keep them from moving. A thin plastic tube will be put into an artery at the wrist or elbow crease area. This will be used to draw blood during the scan. Participants will have 2-5 study visits. Participation lasts 1 week to 4 months, depending on scheduling.

RECRUITING
A Study Comparing GLIADEL to Stereotactic Radiosurgery in Metastatic Brain Disease
Description

This study is being done to see if adding GLIADEL to the site where the tumor was removed works as well as just having the tumor removed with radiation treatment done within six weeks after the surgery to keep the cancer from coming back.

ACTIVE_NOT_RECRUITING
Single Fraction Stereotactic Radiosurgery Compared With Fractionated Stereotactic Radiosurgery in Treating Patients With Resected Metastatic Brain Disease
Description

This phase III trial studies how well single fraction stereotactic radiosurgery works compared with fractionated stereotactic radiosurgery in treating patients with cancer that has spread to the brain from other parts of the body and has been removed by surgery. Single fraction stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Fractionated stereotactic radiosurgery delivers multiple, smaller doses of radiation therapy over time. This study may help doctors find out if fractionated stereotactic radiosurgery is better or worse than the usual approach with single fraction stereotactic radiosurgery.

COMPLETED
P-glycoprotein Function in Brain Diseases
Description

This study will measure the function of a protein called P-glycoprotein (P-gp), which is found at the blood-brain barrier, a membrane that normally prevents toxic material from entering the brain. Impaired P-gp function may allow toxins to enter the brain and cause some people to develop certain brain diseases. Healthy subjects and people with Alzheimer s disease, Parkinson s disease or frontotemporal dementia who are 35 years of age or older and in overall good health may be eligible for this study. Participants undergo the following procedures during three outpatient visits to the NIH Clinical Center: * Medical history, psychological evaluation, physical examination and blood and urine tests, including tests for illegal and addictive drugs. * PET scan: This test uses small amounts of a radioactive chemical called a tracer that labels active areas of the brain so the activity can be seen with a special camera. Before starting the scan, a catheter (plastic tube) is placed in a vein in the arm to inject the tracer. The subject lies on the scanner bed, with a special mask fitted to the head and attached to the bed to help keep the head still during the scan so the images obtained are clear. A brief initial scan is done to calibrate the scanner. Then, a radioactive tracer called \[(15)O\]H(2)O is injected into the catheter and the PET camera takes pictures of blood flow to the brain for about 60 seconds. Next, another tracer, \[(11)C\]dLop, is injected into the catheter and pictures are taken for about 2 hours to determine how much of this tracer is allowed to enter the brain. * Magnetic resonance imaging (MRI): This procedure is done within 1 year (before or after) the PET scan. MRI uses a magnetic field and radio waves to produce images of the brain. For this procedure, the patient lies on a table that can slide in and out of the scanner (a tube-like device), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scan.

COMPLETED
A Study of the Genetic Analysis of Brain Disorders
Description

A study of the complex genetics of brain development will be undertaken with an emphasis on those genes that cause the most common structural brain anomaly in humans called holoprosencephaly (HPE). This malformation of the brain can result from either environmental or genetic causes, and it is the aim of these investigations to determine the genes responsible for both normal and abnormal brain development through the study of patients with this disorder. Mutations in one such gene, Sonic Hedgehog, have been shown by us to be responsible for approximately one quarter of familial cases of HPE. Other genes either related to the hedgehog pathway or located at unrelated defined genetic loci may also contribute to HPE and are the subject of active investigation. We anticipate that many genes important for normal brain development will be identified in the search for genetic causes of HPE.

COMPLETED
Acute Side Effects in Patients Who Are Undergoing Stereotactic Radiosurgery for Brain Tumors or Other Brain Disorders
Description

RATIONALE: Learning about the side effects of stereotactic radiosurgery in patients with brain tumors or other brain disorders may help doctors plan treatment and help patients live more comfortably. PURPOSE: This clinical trial is studying the acute side effects in patients who are undergoing stereotactic radiosurgery for brain tumors or other brain disorders.

RECRUITING
Amygdala Memory Enhancement
Description

The objective is to understand how amygdala activation affects other medial temporal lobe structures to prioritize long-term memories. The project is relevant to disorders of memory and to disorders involving affect and memory, including traumatic brain injury and post-traumatic stress disorder.

RECRUITING
Pilot Study for PET/MR Imaging of Covid-19
Description

The primary goal of this project is to study the feasibility of a prototype brain-dedicated PET insert for an MR scanner for simultaneous acquisition of PET/MR images of metabolism and perfusion in Covid-19 negative and positive/once positive subjects. This study serves as a pilot study for establishing an imaging protocol for combined PET and MR derived functional information as well as MRI acquired anatomical information.

RECRUITING
Clinical Translation of a Novel Brain PET Insert for Simultaneous PET/MR
Description

The primary goal of this project is to study the feasibility of a brain-dedicated PET insert for an MR scanner for simultaneous acquisition of PET/MR images of human brains. The study will also allow us to compare the imaging performance of the investigator's brain-dedicated PET insert against a commercial whole-body permanently integrated PET/MRI system using a common radiopharmaceutical.

Conditions
COMPLETED
Effects of Sensory Flicker and Electrical Flicker Stimulation
Description

The study will evaluate whether sensory flicker can modulate neural activity of deep brain regions in humans, and whether it can have relevant effects on behavior. Moreover, it will compare those effects to the gold-standard method of modulating brain circuits, direct electrical stimulation of the brain (the same mechanism as deep brain stimulation), using a powerful within-subjects design.

Conditions
COMPLETED
pRESET for Occlusive Stroke Treatment
Description

Compare the safety and effectiveness of pRESET to Solitaire in the treatment of stroke related to large vessel occlusion

COMPLETED
Low Intensity Focused Ultrasound for Learning and Memory and Emotion Regulation
Description

The goal of this clinical trial is to investigate the impact of low intensity focused ultrasound pulsation (LIFUP) to two different brain regions, the amygdala and entorhinal cortex, in older adults. The main questions it aims to answer are: 1. Will LIFUP change brain activity in the targeted regions? 2. Will LIFUP to the amygdala have an impact on anxiety and emotion regulation? 3. Will LIFUP to the entorhinal cortex have an impact on memory performance? Participants will complete two in-person visits including neuropsychological testing, MRI of the brain, and LIFUP to the brain.

WITHDRAWN
Study to Develop Head Stabilizer for Use During Brain Radiation Therapy
Description

The purpose of this study is to begin to develop a device to stabilize the head during stereotactic radiosurgery (SRS). SRS is a therapy for brain disorders and cancers that uses a precise dose of radiation to treat a disease, and is different from whole brain radiation. This study aims to stabilize patient head motions during radiation therapy through the use of a special experimental head holder. The investigators would like to first see how the experimental device works in whole brain radiation.

COMPLETED
Intra-individual Open-label, Single Center Study to Compare Unenhanced MRI With Dotarem Enhanced MRI
Description

The goal of this study is to evaluate safety and efficacy of Dotarem enhanced MRI in pediatric and neonatal population who are referred for contrast enhanced MRI at Phoenix Children's Hospital.

Conditions
RECRUITING
Inflammatory and Infectious Diseases of the Nervous System
Description

Background: - Inflammation is how the body reacts to infection or injury. Infections or inflammation in the brain and nerves can be serious. There aren t always good tests to detect this. Researchers want to learn more about how diseases affect the brain and nerves to develop better tests and treatments. Objective: - To learn more about how inflammation and infections hurt the brain and nervous system. Eligibility: - People at least 2 years old with a diagnosis or suspected diagnosis of nervous system infection or inflammation. Design: * For some participants, a clinician outside of NIH will collect blood, tissue, and other samples. These will be sent to NIH and analyzed. * Other participants will have several visits to NIH. Children may not have all these tests. * Participants will have: * Medical history. * Physical and neurological exam. * Blood and urine samples collected. * Saliva collected. They will chew on a piece of sterile cotton for one minute. * Magnetic resonance imaging (MRI) scan. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder. Participants will get a contrast agent through an intravenous (IV) catheter during the MRI. A needle will be used to guide a thin plastic tube (catheter) into an arm vein. * Lumbar puncture. Skin will be numbed and a needle will be inserted into the space between the bones in the back. Fluid will be removed. * Some participants may have optional study procedures. These may include eye tests, memory and thinking testing, tests with electrodes on the head, or skin biopsy.

Conditions
COMPLETED
PET Imaging in Chronic Traumatic Encephalopathy
Description

Background: - Chronic traumatic encephalopathy (CTE) is a brain disease caused in part by head injury. The brain changes from CTE can only be seen at autopsy. Researchers want to test a new brain scan to help diagnose CTE in living patients. Objective: - To determine if a new type of brain scan can detect changes that occur in chronic traumatic encephalopathy. Eligibility: - Adults age 18 60 with previous head injury or participation in certain sports. Design: * Participants will be screened with: * Physical exam * Blood and urine tests * Tests of thinking, mood, and memory * 30-minute magnetic resonance imaging (MRI) brain scan. A magnetic field and radio waves take pictures of the brain. Participants will lie on a table that slides into a metal cylinder. They will get earplugs for the loud knocking sounds. * Visit 1: Participants will have a 70-minute PET scan of the brain with a small amount of a radioactive chemical. That will be injected through an intravenous tube (catheter) in each arm. A catheter will also be put into an artery at the wrist or elbow. * Participants will lie on a bed that slides in and out of a donut-shaped scanner. A plastic mask may be molded to their face and head. Vital signs and heart activity will be checked before and during the scan. * Blood and urine will be taken before and after the scan. * Participants will be checked on by phone the next day. * Visit 2: Participants will repeat Visit 1 with a different chemical and no artery catheter. * Visit 3: Participants may have a spinal tap. Some fluid will be removed by needle between the bones in the back.

COMPLETED
Crossover Comparison of MultiHance and Dotarem
Description

This study aims at a comparison between MultiHance at a dose of 0.1 mmol/kg and 0.05 mmol/kg and Dotarem at a dose of 0.1 mmol/kg in brain tumor patients to show superiority of MultiHance.

Conditions
COMPLETED
Study on Moebius Syndrome and Congenital Facial Weakness Disorders
Description

Background: - Moebius syndrome limits the ability to make facial expressions like smile, frown or blink - and move the eyes laterally. It can also cause speech, swallowing or breathing difficulties and affect parts of the body, such as the limbs, jaw, muscles, or the heart. Some individuals with Moebius can have intellectual impairment or behavior problems. Researchers want to study the clinical features of individuals with Moebius or related disorders and explore the genetic and/or environmental causes of these conditions. Objective: - To learn more about the genetics and clinical characteristics of Moebius syndrome and other Congenital Facial Weakness disorders. Eligibility: - People ages 2 to 80 years with congenital facial weakness, isolated or combined with other congenital anomalies, and their family members. Design: * Participants with Moebius syndrome or other congenital facial weakness disorder will be evaluated at the NIH Clinical Research Center over 3 to 5 days and undergo the following procedures: * Medical and family history and physical examination, including body measurements and vital signs. * Blood or saliva will be collected for genetic tests and to evaluate liver, kidney, heart and hormonal functions. * Eye examination, including having a video taken of their eyes moving. * Hearing evaluation. * Speech and language assessment, including swallowing studies. * Dental exam. * Detailed neurological evaluation, including electromyogram/nerve conduction and blink reflex study. * Rehabilitation medicine evaluation, including muscle and tongue strength testing and assessment of balance. * Neurocognitive and behavioral testing and questionnaires to assess quality of life and copying mechanisms. * Imaging studies of their head, by magnetic resonance and diffusion tensor imaging -MRI/DTI. Participants will lie on a table that slides into a metal cylinder that takes images of internal body structures using magnets. Child participants may be sedated. * Some adults may have additional X-rays of their head or limbs, if there are abnormal findings. * Medical photographs of the face and affected body parts may be taken. * Other specialized tests or consultations, as indicated. * Participants can choose to have a skin biopsy taken. * A follow-up visit will be offered to participants for review of genetic test findings and possibly additional clinical tests, as indicated. Family members of the patients will have a medical and family history and physical examination. Blood or saliva will be obtained for genetic studies.

COMPLETED
Comparison of Prohance® With Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain
Description

This study aims at a direct comparison between ProHance (0.1 mmol/kg) and a validated comparator Gadovist/Gadavist (0.1 mmol/kg) in a crossover intra-individual design in subjects with brain tumors to confirm the identical overall technical and diagnostic performance of the two MR contrast agents.

Conditions
COMPLETED
Dose Finding Study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
Description

The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI with Gadavist Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with OptiMARK.

COMPLETED
A Phase I Study of ABT-888 in Combination With Conventional Whole Brain Radiation Therapy (WBRT) in Cancer Patients With Brain Metastases
Description

This Phase I clinical trial is studying the side effects and best dose of ABT-888 when given together with Whole Brain Radiation Therapy (WBRT) in treating patients with brain metastases.

ENROLLING_BY_INVITATION
Brain Tissue Specimen Collection
Description

The Molecular Neurosurgical Tissue Bank will function as a tissue or specimen repository for biopsy specimens from patients (both adult and pediatric) undergoing brain surgery and brain procedures.

Conditions
UNKNOWN
Oxygen Toxicity of HBOT in Chronic Brain Injury
Description

Hypothesis: That HBOT can be toxic in the low-pressure range.

COMPLETED
Analysis of Brain Tumors Using Matrix Assisted Laser Desorption/Ionization Mass Spectrometry
Description

We are collecting brain tissue specimens and blood samples from patients at Vanderbilt University Medical Center who are undergoing intracranial surgery to remove brain tissue, including brain tumors, tissue from epilepsy surgery and brain tissue removed during surgery for other non-cancerous types of brain tissus. These specimens will then be studied using a novel microscopic laser-directed protein mass spectrometric analysis, looking for unique protein signatures.

Conditions
COMPLETED
Neurologic Injuries in Adults With Urea Cycle Disorders
Description

Urea cycle disorders (UCDs) are a group of rare inherited metabolism disorders. The purpose of this study is to evaluate how UCD-related neurologic injuries affect adults with one of the most common types of UCD.

RECRUITING
Brain Development Research Program
Description

Dr. Elliott Sherr and his collaborators at University of California, San Francisco (UCSF) are studying the genetic causes of disorders of cognition and epilepsy, in particular disorders of brain development that affect the corpus callosum, such as Aicardi syndrome, as well as two additional brain malformations, polymicrogyria and Dandy-Walker malformation. The goal of the investigators' research is to use a better understanding of the underlying genetic causes as a foundation to develop better treatments for these groups of patients.

RECRUITING
Longitudinal Study of Urea Cycle Disorders
Description

Urea cycle disorders (UCD) are a group of rare inherited metabolism disorders. Infants and children with UCD commonly experience episodes of vomiting, lethargy, and coma. The purpose of this study is to perform a long-term analysis of a large group of individuals with various UCDs. The study will focus on the natural history, disease progression, treatment, and outcome of individuals with UCD.

COMPLETED
Differences in Brain Processing of First and Second Languages (Korean and English)
Description

This study will examine differences in how the brain processes English and Korean in native Korean speakers who are fluent and non-fluent in English as a second language. It is thought that people who are non-fluent in a second language process the second language differently from their native language-using different areas of the brain and requiring additional working memory. The study will increase understanding of language acquisition, brain plasticity and bilingualism. Native Korean speakers between 18 and 50 years of age with English as a second language may be eligible for this study. Three groups of individuals will be enrolled: 1) less fluent bilinguals - those who have lived in the United States for at least 1, but less than 2 years and studied English after age 12 and who have a TOEFL (Test of English as a Foreign Language) score above 550; 2) fluent bilinguals with early acquisition - those who were exposed to English before age 7 and lived in the United States after that; and 3) fluent bilinguals with late acquisition - those who were exposed to English after age 12 and lived in the United States after age 10. People with a history of head injury or neurological or thought disorder, left-handed people, and people who cannot read the material used in the study will be excluded from the study. Participants will undergo magnetic resonance imaging (MRI) scanning while reading words in English or Korean; while translating from one language to the other; and while answering questions about the meaning of words in each language. MRI uses a strong magnetic field to image brain tissue. The patient lies on a table that slides into a narrow metal cylinder, which is the scanner. The head is restrained gently with foam padding to limit movement. The patient can see out of the scanner through a mirror and is in contact with the technician via an intercom at all times during the procedure. The scans measures blood flow to different parts of the brain, providing information about what brain regions are being used during the tasks performed. Another scan will be done to obtain a detailed picture of the brain's structure. This study will evaluate the usefulness of MRI in identifying brain areas involved in processing different languages and increase knowledge about how illness affects brain function. It may help plan treatment for bilingual patients who must undergo brain surgery for uncontrolled epilepsy or who have a neurological disorder affecting different languages with varying degrees.