NCT05866003

tDCS + CCFES-mediated Functional Task Practice for Post-stroke Upper Extremity Hemiplegia

tDCS During Contralaterally Controlled FES for Upper Extremity Hemiplegia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: MetroHealth Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

After a stroke, it is very common to lose the ability to open the affected hand. Occupational and physical rehabilitation therapy (OT and PT) combined with non-invasive brain stimulation may help a person recover hand movement. The purpose of this study is to compare 3 non-invasive brain stimulation protocols combined with therapy to see if they result in different amounts of recovery of hand movement after a stroke.

Detailed description

This study is a randomized clinical trail (RCT) of stroke survivors with chronic (6 to 24 months) hemiplegia randomized to: 1) conventional transcranial direct current stimulation (tDCS), 2) unconventional tDCS, or 3) sham tDCS during contralaterally controlled functional electrical stimulation mediated occupational therapy. The treatment will last 12 weeks and be followed by a 6-month follow-up period. Assessors, therapists and participants will be blinded to which tDCS treatment is received. This will be the first RCT of tDCS + CCFES.

Conditions

• Stroke
• Upper Extremity Paresis
• Hemiplegia

Interventions

Type	Name	Description
DEVICE	Active conventional tDCS montage plus CCFES	tDCS is a non-invasive brain stimulation technique. A small machine (9-volt battery operated device) will use a weak amount of electric current to stimulate the brain without any invasive procedure. Electrodes, covered in sponges soaked in saline, will be placed over certain parts of your head and held in place using a rubber strap. In addition, an electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract.
DEVICE	Active unconventional tDCS montage plus CCFES	tDCS is a non-invasive brain stimulation technique. A small machine (9-volt battery operated device) will use a weak amount of electric current to stimulate the brain without any invasive procedure. Electrodes, covered in sponges soaked in saline, will be placed over certain parts of your head and held in place using a rubber strap. In addition, An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract.
DEVICE	Sham tDCS plus CCFES	An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator.
BEHAVIORAL	CCFES with Occupational Therapy	An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator. During the lab visits, all participants will use CCFES to assist hand opening during occupational therapy task practice.

Timeline

• Start date: 2023-07-01
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2023-05-19
• Last updated: 2025-09-29

Locations

1 site across 1 country: United States