12 Clinical Trials for Various Conditions
Objectives Noninvasive stimulation of the central and peripheral nervous system, including transcranial magnetic stimulation (TMS), transcranial direct and alternating current stimulation (tDCS and tACS, respectively) and cutaneous/peripheral nerve stimulation (C/PNS) alone or paired with TMS (paired associative stimulation, PAS), has been increasingly used in the investigation of cortical plasticity and as a possible adjuvant strategy in neurorehabilitation. It has been shown that TMS, tDCS, tACS and C/PNS can modulate motor function in healthy volunteers, as well as in patients with neurological disorders such as stroke. One fundamental problem is that the optimal parameters of stimulation to modulate motor function by all of these techniques are not known. The purpose of this protocol is to explore within safe guidelines, the effects of different stimulation parameters on motor cortical function, on oscillatory brain dynamics measured with magnetoencephalography (MEG) and electroencephalography (EEG), on eye movements, and on fMRI activation. In addition, this protocol will be used to train new fellows coming to NINDS Human Cortical Physiology Section (HCPS) in the use of TMS, tDCS, tACS and C/PNS techniques. We expect that information emerging from these studies will allow us to 1) optimize experimental protocols or stimulation parameters to collect pilot data in healthy volunteer for future patient-oriented hypothesis-driven protocols,2)to collect pilot data for power analysis for future patient-oriented hypothesis driven protocols, and 3) to train new fellows in the use of these different methods. Study Population Up to 1500 healthy volunteers, age 18 and older. Design Healthy volunteers will receive one or more of the following types of stimulation alone or in combination: (1) single- and paired-pulse TMS with inter-stimulus intervals of greater than 1s and up to 20s and intensities of up to 100% of stimulator output; (2) 1 Hz TMS for up to 30mins and up to 115% of resting motor threshold (RMT) intensity; (3) tDCS applied at an intensity of up to 4 mA for a duration of up to 60mins, as long the total charge does not exceed 7.2 C; (4) tACS applied at a peak-to-peak intensity of up to 4 mA for a duration of up to 60 minutes, minutes, as long the total charge does not exceed 7.2 C; (5) C/PNS applied alone with intensities below 130% of the peripherally-elicited-motor-threshold for up to 2 hours, or intensities up to 300% of sensory threshold when C/PNS is paired with TMS. All of these parameters of stimulation and procedures have safely been used as previously reported in the literature. Sham stimulations will be delivered for each modality as scientifically needed. Some substudies may involve recording of behavior or brain activity only (such as behavioral testing, MRI, and MEG) if brain stimulation targets are unknown. This information can help design future brain stimulation protocols. Each subject may participate in up to 20 sessions. A single session may last no longer than 8 hours to allow for initial testing paradigm followed by retests or performing other components of the same substudy later in the day. Appropriate rest breaks and meal breaks will occur during long sessions. Subjects participate in one experimental session per day under this protocol. The 20 experimental sessions will be scheduled over a twenty-year period. CTDB is used to track the number of sessions per subject so it does not exceed 20 sessions. The AIs are responsible for entering the subjects/sessions into CTDB. We will test the effects of these different forms of stimulation on motor cortical excitability, cognitive and motor behavioral tasks, and brain state measures derived from neuroimaging data (i.e. - MRI, fMRI, MEG and EEG). Stimulation may be applied before, after, or during physiological (i.e. motor evoked potentials, M-wave, F-wave, or H-Reflexes), neuroimaging or behavioral measures. Under this protocol, we conduct: Exploratory Sub-studies: These substudies are exploratory in nature and are conducted in order to develop information to generate better informed future hypotheses and/or power analyses. We have set an upper limit of 40 subjects per sub-study. Hypothesis-Testing Sub-studies: Hypothesis-testing sub-studies are studies with specific hypotheses to be tested. These sub-studies undergo statistical and PIRC review after 6 subjects per group (e.g., after 12 subjects, 6 per arm, if two groups are studied), before additional subjects can be recruited. Together, the P.I. and PIRC will decide whether to continue the sub-study with more subjects without an amendment or whether an amendment or protocol would be necessary. A memo requesting a review of hypothesis-testing sub-studies for possible additional enrollment (beyond 6) will be sent to PIRC and the statistical reviewer. This protocol is ...
The purpose of this research study is to explore ways to improve motor, cognitive and immune functions for aging adults using multiple techniques like lifestyle changes and risk factor management, as well as medications and supplements believed to have a positive effect on health.
The purpose of this study is to understand how the brain controls movement and how Non-invasive Brain Stimulation (NIBS) with a technique called High-density transcranial direct current stimulation (HD-tDCS) can alter brain processes to improve behavior. Participants in this study will be randomized to either HD-tDCS with standard intervention or personalized dose-controlled multifocal network-targeted HD-tDCS. The hypothesis is that dexterous hand function will improve after a standard HD-tDCS dose and increase even more after personalized dose-controlled multifocal network-targeted HD-tDCS.
This project will study the feasibility of motor rehabilitation in people with cerebellar ataxia using real-time functional magnetic resonance imaging neurofeedback (rt-fMRI NF) in conjunction with motor imagery. To do so, data will be collected from healthy adults in this protocol, to be compared with data from cerebellar ataxia participants.
Background: When people have a stroke, they often have difficulty moving their arms and hands. Transcranial magnetic stimulation (TMS) can improve how well people with and without stroke can move their arms and hands. But the effects of TMS are minor, and it doesn t work for everyone. Researchers want to study how to time brain stimulation so that the effects are more consistent. Objective: To understand how the brain responds to transcranial magnetic stimulation so that treatments for people with stroke can be improved. Eligibility: Adults ages 18 and older who had a stroke at least 6 months ago Healthy volunteers ages 50 and older Design: Participants will have up to 5 visits. At visit 1, participants will be screened with medical history and physical exam. Participants with stroke will also have TMS and surface electromyography (sEMG). For TMS, a brief electrical current will pass through a wire coil on the scalp. Participants may hear a click and feel a pull. Muscles may twitch. Participants may be asked to do simple movements during TMS. For sEMG, small electrodes will be attached to the skin and muscle activity will be recorded. At visit 2, participants will have magnetic resonance imaging (MRI). They will lie on a table that slides into a metal cylinder in a strong magnetic field. They will get earplugs for the loud noise. At visit 3, participants will have TMS, sEMG, and electroencephalography (EEG). For EEG, small electrodes on the scalp will record brainwaves. Participants will sit still, watch a movie, or do TMS. Participants may be asked to have 2 extra visits to redo procedures.
This study will evaluate new assessment tools and equipment and new ways of using existing tools and equipment in the NIH Clinical Center s Rehabilitation Medicine Department in order to maximize patients function. The Department assesses and treats NIH patients with chronic pain, problems in walking or getting around, activities of daily living, performing tasks needed for jobs or hobbies, communicating and chewing and swallowing. Children and adults of all ages with disabilities and healthy normal volunteers may be eligible for this study. The following kinds of assessments are evaluated in this study: Assessments of Impairments Impairments are problems such as loss of movement, weakness or loss of sensation. Assessments may include measurements of range of motion, strength, sensation, pain, joint stability or mobility, joint angles, limb and girth, gait, exercise tolerance, stamina, or ultrasound imaging of muscle and swallowing function. Assessments of Function and Performance Functional and performance assessments look at how well subjects perform actions, such as walking or getting around, dressing, or preparing meals. They may include evaluations of activities of daily living, leisure activities, fatigue, vocational activity, school activity, coping skills, and quality of life. The assessments may be done by questionnaires or interviews and by watching subjects perform the activities. Assessments of Treatment Techniques Treatment techniques are assessed by evaluating methods and equipment used to treat patients with impairments or problems with function. They may evaluate, for example, the use of heat, cold, strengthening exercises, fitness exercises, TENS units, splinting and orthotics, or shoe modifications.
Neurological impairment such as stroke and aging is a leading cause of adult disability. Traditional rehabilitative therapies can help regain motor function and ameliorate disability. There are increasing community and other facilities offering rehabilitation in the form of conventional, recreational and alternative (Yoga, Tai-chi) therapy. However, the implementation of these conventional therapy techniques in individuals with a neurological disorder like stroke and the elderly population is tedious, resource-intensive, and costly, often requiring transportation of patients to specialized facilities. Based on recent evidence suggesting significant benefits of repetitive, task-orientated training, investigators propose to evaluate the feasibility of an alternative therapies such as exergaming based therapy to improve overall physical function of community-dwelling individuals with neurological impairments and the elderly, compared to conventional therapeutic rehabilitation. This pilot study aims to systematically obtain pilot data on compliance and efficacy as well as performing power analysis and sample size calculation for developing it into a randomized controlled trial for extramural funding purposes. The objective of the study is to determine the safety, feasibility, compliance and efficacy of exergaming therapy to improve overall physical function of community-dwelling chronic stroke individuals and the elderly population.
The neurosurgical standard of care for treating a patient with a tumor invading hand primary motor cortex (M1) includes performing a craniotomy with intraoperative direct electrical stimulation (DES) mapping and to resect as much tumor as possible without a resultant permanent neurological deficit. However, the subjective nature of current intraoperative hand motor assessments do not offer a comprehensive understanding of how hand strength and function may be impacted by resection. Additionally, there is a paucity of data to inform how altering DES parameters may effect motor mapping. Here, the investigators seek to demonstrate a feasible, standardized protocol to quantitatively assess hand strength and function and systematically assess several stimulation parameters to improve intraoperative measurements and better understand how cortical stimulation interacts with underlying neural function.
Background: Training in a new motor skill often involves periods of active practice and periods of rest. During early motor skill learning, improvements in performance usually happen during the short rest periods between practice sessions. Researchers want to use improved imaging techniques to study the contributions of specific parts of the brain to how people learn and retain movement skills. Objective: To learn the part played by different layers in the brain in retaining a newly learned movement skill. Eligibility: Healthy, right-handed, English-speaking people age 18-50. Design: Participants will be screened with: * Medical and neurological history * Medicine review * Physical exam * Neurological exam. Participants may have 2 magnetic resonance imaging (MRI) scans of the brain. During the MRI, they will lie in the scanner. The scanner makes noise. They will get earplugs. Participants will have behavior testing. A specific order of keys will be displayed on a computer screen. Participants will practice typing the keys with their left hand 36 times (in 10-second blocks). They will repeat this test with a random order of keys. Participants will see single numbers displayed one after the other on the computer screen. They will make single tap responses using the finger that corresponds with the number on the screen. Participants will have up to 4 study sessions. Each session will take about 5 hours.
Background: - Two areas on the surface of the brain, the dorsolateral prefrontal cortex (DLPFC) and motor cortex (MC), play a key role during learning. Researchers are interested in determining the effect that transcranial magnetic stimulation (TMS) on the DLPFC and MC has on participants' performance of learning tasks. By studying the effect of TMS on reaction time, learning, and memory, researchers hope to better understand how to treat conditions such as Parkinson's disease and traumatic brain injury that affect these parts of the brain. Objectives: * To study the effects of transcranial magnetic stimulation on the dorsolateral prefrontal cortex and motor cortex. * To learn which areas of the brain are used to perform certain learning and memory tasks. Eligibility: - Healthy, right-handed individuals between 18 and 70 years of age. Design: * Participants will be screened with a physical and neurological examination and a medical and psychiatric history. * Participants will be asked to take part in one of five different parts of this study. Most participants will have four 2-hour visits to the National Institutes of Health Clinical Center. Some participants (those involved in Part 5) will have only one 2-hour visit. * Parts 1 and 2 (four visits): Participants will have TMS, and then do a learning task that may provide a small monetary reward. On the first visit, before the TMS, participants will take an intelligence test based on reading aloud the words given on a card. Participants who have not had a routine magnetic resonance imaging (MRI) scan of the brain within the past year will also have a scan. * Parts 3 and 4 (four visits): Participants will have a functional MRI scan while doing a learning task that may provide a small monetary reward. On the first visit, before the functional MRI, participants will take an intelligence test based on reading aloud the words given on a card. Participants who have not had a routine magnetic resonance imaging (MRI) scan of the brain within the past year will also have a scan. * Part 5 (one visit): Participants will take an intelligence test based on reading aloud the words given on a card. Then, participants will have TMS followed by a functional MRI scan. During the functional MRI, participants will do a button-pressing task that may provide a small monetary reward. * Participants will also be asked to provide a small blood sample for genetic analysis.
The goal of this study is to determine which parts of the brain make it possible for some people to move skillfully with their left non-dominant hand.
Positron Emission Tomography (PET) is a technique used to investigate activity in areas of the brain. The PET technique allows researchers to study the normal processes in the brain (central nervous system) of normal individuals and patients with neurologic illnesses without physical / structural damage to the brain. When a region of the brain is active, it uses more fuel in the form of oxygen and sugar (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and water. Blood carries fuel to the brain and waste products away from the brain. As brain activity increases, blood flow to and from the area of activity also increases. This is known as regional cerebral blood flow (rCBF). Knowing these facts, researchers can use radioactive water (H215O) and PET scans to observe what areas of the brain are receiving more blood flow. In this study researchers plan to investigate the changes in regional cerebral blood flow (rCBF) as patients participate in different activities. The activities are designed to stimulate the areas of the brain responsible for voluntary motor activity and sensation. By comparing the results of PET scans performed in different conditions, researchers can locate regions of the brain responsible for specific tasks. This study should provide new information about voluntary movements in humans and the preparation involved in controlling them.