Targeted Noninvasive Brain Stimulation to Improve Hand Dexterity in Stroke Patients

Stroke Clinical Trial

— T-NIBS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04058288
• Other study ID #: R-1056-19
• Status: Completed
• Start date: October 28, 2019
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2023
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 31, 2023
• Est. primary completion date: February 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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