Clinical trial NCT04058288: Targeted Noninvasive Brain Stimulation to Improve Hand Dexterity in Stroke Patients
Official title: Targeted Noninvasive Brain Stimulation (T-NIBS) for Improving Hand Dexterity in Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: stroke
HD-tDCS
musicglove
Upper-limb rehab
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Changes in the Nine-Hole Peg Test (NHPT) scores
timeFrame: baseline (at day 1), during testing visits (day 2 and day 3)- all within 2 weeks from the screening and consenting
measure: Changes in the Dexterity and Speed Test (DAST) scores
timeFrame: baseline (at day 1), during testing visits (day 2 and day 3)- all within 2 weeks from the screening and consenting
Secondary outcomes:
measure: Changes in the Cortical Excitability using Motor Evoked Potentials (MEP)
timeFrame: baseline (at day 1), during testing visits (day 2 and day 3) - all within 2 weeks from the screening and consenting
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Guang Yue, PhD
role: STUDY_DIRECTOR
References: