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Targeted Noninvasive Brain Stimulation to Improve Hand Dexterity in Stroke Patients (T-NIBS)

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ClinicalTrials.gov Identifier: NCT04058288
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Vikram Shenoy Handiru, Kessler Foundation

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.

Condition or disease Intervention/treatment
Stroke Device: High-definition Transcranial Direct Current Stimulation

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.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Targeted Noninvasive Brain Stimulation (T-NIBS) for Improving Hand Dexterity in Stroke Patients
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : November 2020

Group/Cohort Intervention/treatment
Stroke
People suffering from upper-limb motor dysfunction due to stroke
Device: High-definition Transcranial Direct Current Stimulation
Stimulation sessions will be conducted on 2 different visits separated by 2-week gap. In a crossover design, Anodal HD-tDCS will be delivered either in Active/Sham mode (during the first visit) and Sham/Active during the second visit in a 4x1 ring configuration (center electrode being Anode and the surrounding 4 electrodes being cathodes) over the affected motor area.




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Changes in the Cortical Excitability using Motor Evoked Potentials (MEP) [ Time Frame: baseline (at day 1), during testing visits (day 2 and day 3) - all within 2 weeks from the screening and consenting ]
    MEP outcome measures have become the norm in brain stimulation studies. We hypothesize that the MEP amplitude and latency before- and after-intervention would reveal more information about the neuroplasticity changes during motor recovery. The motor evoked potential (MEP) will be provided by twenty unconditioned stimuli (120% RMT).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primarily, the stroke survivors from the New Jersey/New York City area. Although not restricted to any primary care clinic, we encourage participants from the Kessler Institute for Rehabilitation.
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058288


Contacts
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Contact: VIKRAM Shenoy HANDIRU, PhD 9733243578 vshenoy@kesslerfoundation.org
Contact: Danit Mark, MS dmark@kesslerfoundation.org

Locations
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United States, New Jersey
Kessler Foundation Recruiting
West Orange, New Jersey, United States, 07052-1424
Contact: Vikram Shenoy Handiru    973-324-3578    vshenoy@kesslerfoundation.org   
Sub-Investigator: Didier Allexandre, PhD         
Sponsors and Collaborators
Kessler Foundation
Investigators
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Study Director: Guang Yue, PhD Kessler Foundation

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Responsible Party: Vikram Shenoy Handiru, Associate Research Scientist, Kessler Foundation
ClinicalTrials.gov Identifier: NCT04058288     History of Changes
Other Study ID Numbers: R-1056-19
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Vikram Shenoy Handiru, Kessler Foundation:
stroke
HD-tDCS
musicglove
Upper-limb rehab
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases