Skip to content

Targeted Noninvasive Brain Stimulation to Improve Hand Dexterity in Stroke Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04058288
Acronym
T-NIBS
Enrollment
7
Registered
2019-08-15
Start date
2019-10-28
Completion date
2023-05-31
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

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

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.

Interventions

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.

Sponsors

Kessler Foundation
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in the Nine-Hole Peg Test (NHPT) scoresbaseline (at day 1), during testing visits (day 2 and day 3)- all within 2 weeks from the screening and consentingNHPT 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) scoresbaseline (at day 1), during testing visits (day 2 and day 3)- all within 2 weeks from the screening and consentingDAST 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

MeasureTime frameDescription
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 consentingMEP 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026