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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
MetroHealth Medical Center
Study ID
NCT05866003
Status
Recruiting
Apply to this trial

Conditions

  • Hemiplegia
  • Stroke
  • Upper Extremity Paresis

Eligibility Criteria

Sex
ALL
Age
21 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Active conventional tDCS montage plus CCFES — DEVICE
    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.
  • Active unconventional tDCS montage plus CCFES — DEVICE
    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.
  • Sham tDCS plus CCFES — DEVICE
    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.
  • CCFES with Occupational Therapy — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jul 1, 2023
Status verified
Sep 2025
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
63 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active conventional tDCS plus CCFES
    The conventional tDCS montages involves placing the surface anode electrode on the scalp of the lesioned hemisphere and the surface cathode electrode on the scalp of the non-lesioned hemisphere. TDCS will deliver a low current while participants are undergoing CCFES-mediated functional task practice.
  • Active Comparator: Active unconventional tDCS plus CCFES
    The unconventional tDCS montages involves placing the surface anode electrode on the scalp of the non-lesioned hemisphere and the surface cathode electrode on the scalp of the lesioned hemisphere. TDCS will deliver a low current while participants are undergoing CCFES-mediated functional task practice.
  • Sham Comparator: Sham tDCS plus CCFES
    The sham tDCS montages involves placing the surface electrodes on the scalp over the lesioned and the non-lesioned hemisphere. TDCS will not be delivered during CCFES-mediated functional task practice.

Primary Outcome Measure

Box and Blocks Test (BBT) [ Time Frame: Change in BBT will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MetroHealth Medical CenterClevelandOhio44109
Amy Friedl, MS, OTR/L
[email protected]
216-957-3598
David A Cunningham, PhD
[email protected]
216-957-3349

Find similar trials in Cleveland, OH

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
MetroHealth Medical Center· Cleveland, OH

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