Improving hand motor functions in brain injury patients using brain stimulation and music-based exercises
Targeted Noninvasive Brain Stimulation (T-NIBS) for Upper Extremity Motor Rehabilitation in Acquired Brain Injury (ABI) Patients
This study is testing whether using brain stimulation along with music-based video game exercises can help improve hand movement in people who have had brain injuries like strokes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Kessler Foundation Academic / other |
| Locations | 1 site (West Orange, New Jersey) |
| Trial ID | NCT04057105 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of targeted non-invasive brain stimulation combined with music-assisted video game exercises to enhance hand motor functions in individuals with acquired brain injuries, such as stroke and traumatic brain injury. The approach aims to address persistent upper extremity dysfunction by personalizing the stimulation protocol to each patient's specific brain injury characteristics. Participants will undergo high-definition transcranial direct current stimulation (HD-tDCS) while engaging in MusicGlove exercises designed to improve hand dexterity. The study will also monitor changes in brain activity through EEG to evaluate the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of acquired brain injury, such as stroke or traumatic brain injury, who experience weak hand and finger movements at least six months post-injury.
Not a fit: Patients who are unable to move their hands due to severe muscle stiffness or have lost sensation in their hands may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve hand motor functions and daily living activities for patients with upper extremity dysfunction following brain injuries.
How similar studies have performed: While non-invasive brain stimulation has shown promise in stroke rehabilitation, the combination of HD-tDCS with music-assisted exercises in the TBI population is a novel approach that has not been extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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 tinnitus or severe hearing problems * Have a tattoo with metal-based ink in the head or neck. * Have severe skin damage on the scalp * Afraid of confined spaces (claustrophobic) * Have metallic implants, including intracranial electrodes, surgical clips, shrapnel or a pacemaker. * Currently taking medications that increase the risk of seizures * Pregnant
Where this trial is running
West Orange, New Jersey
- Kessler Foundation — West Orange, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Vikram Shenoy Handiru, PhD
- Email: vshenoy@kesslerfoundation.org
- Phone: 9733243578
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.