Targeted Noninvasive Brain Stimulation (T-NIBS) to Improve Hand Motor Functions in Acquired Brain… (NCT04057105) | Clinical Trial Compass
CompletedNot Applicable
Targeted Noninvasive Brain Stimulation (T-NIBS) to Improve Hand Motor Functions in Acquired Brain Injury
United States14 participantsStarted 2020-10-01
Plain-language summary
Acquired Brain Injury (TBI) is a serious medical and health problem in the US. Individuals with an acquired brain injury due to stroke and Traumatic Brain Injury (TBI) commonly suffer from upper extremity physical impairments that persist even after years of injury; these deficits are attributed to the damage to brain structure and changes in structural and functional connectivity. Although the conventional rehabilitation approaches are helpful in assisting motor recovery often there is a complaint of fatigue due to the repetitive tasks and also, nearly half of the ABI survivors do not regain their ability to use their arms for daily activities.
To address this issue, Dr. Shenoy's proposed study will investigate the combined use of individually targeted non-invasive brain stimulation and music-assisted video game-based hand exercises to achieve functional recovery. Further, the project will also investigate how the intervention modulates brain activity (recorded using EEG) in terms of brain connectivity before- and after the -intervention. In the end, this study will allow us to understand the cortical dynamics of ABI rehabilitation upon brain stimulation. Extending further, this could pave the way to advance the knowledge of behavioral and neural aspects of motor control in patients with different types of neuromuscular disorders.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:18 and 75 years
* Confirmed diagnosis of Acquired brain injury (individuals with stroke or Traumatic Brain Injury)
* At least 6 months post-injury
* Complaints of weak movement of hands and fingers
* Ability to understand the instructions that are part of the tDCS-MusicGlove testing and intervention
* Willingness and ability to participate in and travel to Kessler Foundation for the baseline assessment visits, 10 training visits, and post-training follow-up visits
* Ability to sit and be active for 2 hours on a chair (or wheelchair) without cardiac, respiratory and/or pain disturbances as assessed during the screening visit.
* Willingness to give written informed consent.
* Medically stable and not planning for a major change in medications for at least 4 months
Exclusion Criteria:
* Unable to move the hand because of muscle stiffness (scoring 3 or more on the Ashworth scale)
* Have lost the sensation of hand movement
* Have a history of alcohol abuse and/or illicit drug use
* Have a problem with the eyesight that would make it difficult to notice the changing instructions on a computer screen
* Currently enrolled in another research study that might affect this research study
* A history of epilepsy (including family members who are diagnosed with epilepsy)
* An active history of migraine or chronic headache
* A history of mental illness (e.g. schizophrenia, anxiety, depression, and PTSD)
* Past or current history of treated ringing in the ears known as…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change scores of Box and Block test (BBT)
Timeframe: baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)
2
Change scores of Upper-extremity Fugl-Myer Assessment (UEFMA)
Timeframe: baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)