Targeted Noninvasive Brain Stimulation to Improve Hand Dexterity in Stroke Patients

NCT04058288 | Completed FDA Device

• 1 other identifier: R-1056-19
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; HD-tDCS; musicglove; Upper-limb rehab

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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 Arms (1)

Stroke

People suffering from upper-limb motor dysfunction due to stroke

Device: High-definition Transcranial Direct Current Stimulation

Interventions

High-definition Transcranial Direct Current Stimulation DEVICE

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.

Stroke

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052-1424, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Guang Yue, PhD

  Kessler Foundation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Scientist

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 15, 2019
• Study Start: October 28, 2019
• Primary Completion: February 14, 2022
• Study Completion: May 31, 2023
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)