Status:
COMPLETED
Targeted Noninvasive Brain Stimulation (T-NIBS) to Improve Hand Motor Functions in Acquired Brain Injury
Lead Sponsor:
Kessler Foundation
Conditions:
Upper Extremity Dysfunction
Traumatic Brain Injury
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 extre...
Detailed Description
Persistent physical deficits associated with upper extremities including motor weakness, spasticity, and the lack of bimanual coordination of fingers, hands, and arms are particularly problematic as i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04057105
Start Date
October 1 2020
End Date
December 30 2024
Last Update
August 6 2025
Active Locations (1)
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1
Kessler Foundation
West Orange, New Jersey, United States, 07052