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

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Conditions

Upper Extremity DysfunctionTraumatic Brain InjuryHD-tDCSTBIUpper limb rehabhand dexterityMusicGloveNoninvasive Brain Stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Targeted Noninvasive Brain Stimulation (T-NIBS) for Upper Extremity Motor Rehabilitation in Acquired Brain Injury (ABI) Patients

Quick Facts

Study Start:2020-10-01
Study Completion:2024-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04057105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed diagnosis of Acquired brain injury (individuals with stroke or Traumatic Brain Injury)
  2. * At least 6 months post-injury
  3. * Complaints of weak movement of hands and fingers
  4. * Ability to understand the instructions that are part of the tDCS-MusicGlove testing and intervention
  5. * 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
  6. * 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.
  7. * Willingness to give written informed consent.
  8. * Medically stable and not planning for a major change in medications for at least 4 months
  1. * Unable to move the hand because of muscle stiffness (scoring 3 or more on the Ashworth scale)
  2. * Have lost the sensation of hand movement
  3. * Have a history of alcohol abuse and/or illicit drug use
  4. * Have a problem with the eyesight that would make it difficult to notice the changing instructions on a computer screen
  5. * Currently enrolled in another research study that might affect this research study
  6. * A history of epilepsy (including family members who are diagnosed with epilepsy)
  7. * An active history of migraine or chronic headache
  8. * A history of mental illness (e.g. schizophrenia, anxiety, depression, and PTSD)
  9. * Past or current history of treated ringing in the ears known as tinnitus or severe hearing problems
  10. * Have a tattoo with metal-based ink in the head or neck.
  11. * Have severe skin damage on the scalp
  12. * Afraid of confined spaces (claustrophobic)
  13. * Have metallic implants, including intracranial electrodes, surgical clips, shrapnel or a pacemaker.
  14. * Currently taking medications that increase the risk of seizures
  15. * Pregnant

Contacts and Locations

Principal Investigator

Guang Yue, PhD
STUDY_DIRECTOR
Kessler Foundation

Study Locations (Sites)

Kessler Foundation
West Orange, New Jersey, 07052
United States

Collaborators and Investigators

Sponsor: Kessler Foundation

  • Guang Yue, PhD, STUDY_DIRECTOR, Kessler Foundation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-01
Study Completion Date2024-12-30

Study Record Updates

Study Start Date2020-10-01
Study Completion Date2024-12-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Upper Extremity Dysfunction
  • Traumatic Brain Injury