Targeted Noninvasive Brain Stimulation to Improve Hand Dexterity in Stroke Patients (T-NIBS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04058288|
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : September 9, 2019
|Condition or disease||Intervention/treatment|
|Stroke||Device: High-definition Transcranial Direct Current Stimulation|
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|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|
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.
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058288
|Contact: VIKRAM Shenoy HANDIRU, PhDemail@example.com|
|Contact: Danit Mark, MSfirstname.lastname@example.org|
|United States, New Jersey|
|West Orange, New Jersey, United States, 07052-1424|
|Contact: Vikram Shenoy Handiru 973-324-3578 email@example.com|
|Sub-Investigator: Didier Allexandre, PhD|
|Study Director:||Guang Yue, PhD||Kessler Foundation|