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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052-1424
      • Kessler Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the Nine-Hole Peg Test (NHPT) scores	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.	baseline (at day 1), during testing visits (day 2 and day 3)- all within 2 weeks from the screening and consenting
Changes in the Dexterity and Speed Test (DAST) scores	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.	baseline (at day 1), during testing visits (day 2 and day 3)- all within 2 weeks from the screening and consenting

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Investigators: Study Director: Guang Yue, PhD, Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2019
• Primary Completion (Actual): February 14, 2022
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: July 29, 2019
• First Submitted That Met QC Criteria: August 14, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: stroke; HD-tDCS; musicglove; Upper-limb rehab
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: R-1056-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No