Targeted Noninvasive Brain Stimulation to Improve Hand Dexterity in Stroke Patients

NCT ID: NCT04058288

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-28
• Study Completion Date: 2023-05-31

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.

Conditions

Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Stroke

People suffering from upper-limb motor dysfunction due to stroke

High-definition Transcranial Direct Current Stimulation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Vikram Shenoy Handiru

Associate Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guang Yue, PhD

Role: STUDY_DIRECTOR

Kessler Foundation

Locations

Kessler Foundation

West Orange, New Jersey, United States

Countries

United States

Other Identifiers

R-1056-19

Identifier Type: -

Identifier Source: org_study_id