Targeted Noninvasive Brain Stimulation (T-NIBS) to Improve Hand Motor Functions in Acquired Brain Injury

NCT04057105 | Completed FDA Device

• 1 other identifier: R-1067-19
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Upper Extremity Dysfunction; Traumatic Brain Injury

Keywords

HD-tDCS; TBI; Upper limb rehab; hand dexterity; MusicGlove; Noninvasive Brain Stimulation

Outcome Measures

Primary Outcomes (2)

• Change scores of Box and Block test (BBT)

  BBT is an easy-to-evaluate inexpensive test which mainly evaluates the unilateral gross dexterity. The MusicGlove exercise that is proposed in this study recruits the finger muscles which are for fine motor coordination. During this test, the participant will be asked to move one-by-one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds.

  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)

  Upper extremity Fugl-Meyer Assessment Score (UEFMA) primarily evaluates the functions of Shoulder/Elbow and Forearm, Wrist, Hand and Coordination and Speed in a series of performed tasks. The maximum score associated with the UE-FMA is 66 points. Each of the 33 specific tasks is scored as either 0 or an absence of function to a maximum score of 2 for the tasks being fully completed. The partial function can be scored as 1 for selected tasks. The change in scores from baseline-to-post-intervention and post-intervention-to-2-month-followup will be assessed.

  baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)

Secondary Outcomes (6)

• Change scores of Action Research Arm Test (ARAT)

  baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)

• Change scores of Nine Hole Peg Test (NHPT)

  baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)

• Change scores of Dexterity and Speed Test (DAST)

  baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)

• Changes in the Cortical Excitability using Motor Evoked Potentials (MEP)

  baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)

• Quality of Life After Brain Injury (QOLIBRI)

  baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)

Study Arms (2)

MusicGlove and Active HD-tDCS

ACTIVE COMPARATOR

During Active HD-tDCS, current up to 2mA will be delivered transiently for only 30 seconds and it will be turned ON for the remainder of 20 minutes.

Device: Active High-definition Transcranial Direct Current Stimulation (HD-tDCS); Device: MusicGlove

MusicGlove and Sham HD-tDCS

SHAM COMPARATOR

During Sham HD-tDCS, current up to 2mA will be delivered transiently for only 30 seconds to simulate the real-tDCS based skin sensation.

Device: MusicGlove

Interventions

Active High-definition Transcranial Direct Current Stimulation (HD-tDCS) DEVICE

Stimulation sessions will be conducted once a day on 10 weekdays over a period of 2-3 weeks. Anodal HD-tDCS will be delivered either in Active or Sham mode (as per the randomized order) in a 4x1 ring configuration (center electrode being Anode and the surrounding 4 electrodes being cathodes) over the affected motor area.

MusicGlove and Active HD-tDCS

MusicGlove DEVICE

Both groups will undergo MusicGlove video-game based hand exercises.

MusicGlove and Active HD-tDCS; MusicGlove and Sham HD-tDCS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

Related Publications (3)

• Beaulieu LD, Milot MH. Changes in transcranial magnetic stimulation outcome measures in response to upper-limb physical training in stroke: A systematic review of randomized controlled trials. Ann Phys Rehabil Med. 2018 Jul;61(4):224-234. doi: 10.1016/j.rehab.2017.04.003. Epub 2017 Jun 7.

  PMID: 28579362 BACKGROUND

• De Vico Fallani F, Richiardi J, Chavez M, Achard S. Graph analysis of functional brain networks: practical issues in translational neuroscience. Philos Trans R Soc Lond B Biol Sci. 2014 Oct 5;369(1653):20130521. doi: 10.1098/rstb.2013.0521.

  PMID: 25180301 BACKGROUND

• Friedman N, Chan V, Reinkensmeyer AN, Beroukhim A, Zambrano GJ, Bachman M, Reinkensmeyer DJ. Retraining and assessing hand movement after stroke using the MusicGlove: comparison with conventional hand therapy and isometric grip training. J Neuroeng Rehabil. 2014 Apr 30;11:76. doi: 10.1186/1743-0003-11-76.

  PMID: 24885076 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Guang Yue, PhD

  Kessler Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blinded (participant and the investigator are blinded from knowing the HD-tDCS allocation sequence)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 15, 2019
• Study Start: October 1, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)