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Clinical Trials/NCT04058288
NCT04058288
Completed
Not Applicable

Targeted Noninvasive Brain Stimulation (T-NIBS) for Improving Hand Dexterity in Stroke Patients

Kessler Foundation1 site in 1 country7 target enrollmentOctober 28, 2019
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Kessler Foundation
Enrollment
7
Locations
1
Primary Endpoint
Changes in the Nine-Hole Peg Test (NHPT) scores
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This study will investigate the use of High-definition Transcranial Direct Current Stimulation (HD-tDCS) in the functional improvement of hand dexterity while performing music-assisted hand exercises.

Detailed Description

Stroke is a serious medical and health problem in the US, and most of the stroke patients suffer from upper-limb motor deficits including weakened hand dexterity. As upper-limb motor functions are crucial for most of the daily living activities, there is a need for effective intervention. The current therapeutic approaches involve intensive physical therapy training involving repetitive tasks which causes fatigue and lack of engagement in the patients. To address this issue, the investigators will investigate the combined use of individually targeted noninvasive brain stimulation (T-NIBS) using High-definition Transcranial Direct Current Stimulation (HD-tDCS) and music-assisted hand exercises using MusicGlove to modulate the neuroplasticity in the desired manner to observe functional changes in hand dexterity.

Registry
clinicaltrials.gov
Start Date
October 28, 2019
End Date
May 31, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Kessler Foundation
Responsible Party
Principal Investigator
Principal Investigator

Vikram Shenoy Handiru

Associate Research Scientist

Kessler Foundation

Eligibility Criteria

Inclusion Criteria

  • Aged between 18-75 years
  • Clinically diagnosed with hemiparetic stroke (weakness on one side - either left or right side of the body)
  • Have had a stroke for more than 6 months
  • Have weakness in moving the fingers of the affected hand
  • Able to understand and perform the instructions that are part of the tDCS-MusicGlove testing and intervention.
  • Willing and able to participate in and travel to Kessler Foundation for the screening session, MRI session, and tDCS-MusicGlove sessions.
  • Able to sit and be active for 1.5 hours during the session without cardiac, respiratory and/or pain disturbances as assessed during the screening visit.
  • Able to provide informed consent.
  • Medically stable and not planning for a major change in medications for at least 4 weeks

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 history of smoking within the past 5 years
  • 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

Outcomes

Primary Outcomes

Changes in the Nine-Hole Peg Test (NHPT) scores

Time Frame: baseline (at day 1), during testing visits (day 2 and day 3)- all within 2 weeks from the screening and consenting

NHPT is a secondary outcome measure of finger dexterity that can be used in stroke patients with upper extremity motor deficits. It is considered to be a reliable measure of hand dexterity and recommended for inclusion in NIH toolbox Assessment of Neurological and Behavioral Function. NHPT requires participants to repeatedly place nine pegs into nine holes, one at a time, as quickly as possible and then remove them from the holes. The total time needed to complete the task is then recorded.

Changes in the Dexterity and Speed Test (DAST) scores

Time Frame: baseline (at day 1), during testing visits (day 2 and day 3)- all within 2 weeks from the screening and consenting

DAST is exclusively developed for MusicGlove performance assessment and it is designed to evaluate how fast and accurately do the subjects respond to the sequence of music notes that continuously sped up.

Secondary Outcomes

  • Changes in the Cortical Excitability using Motor Evoked Potentials (MEP)(baseline (at day 1), during testing visits (day 2 and day 3) - all within 2 weeks from the screening and consenting)

Study Sites (1)

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