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 range18 Years – 75 Years

SexALL

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…

What they're measuring

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)

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)

Trial details

NCT IDNCT04057105

SponsorKessler Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-30

View on ClinicalTrials.gov More Upper Extremity Dysfunction trials

Plain-language summary

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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)

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)