Recruiting

tDCS & CCFES

Sponsor:

MetroHealth Medical Center

Code:

NCT05866003

Conditions

Stroke

Upper Extremity Paresis

Hemiplegia

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Active conventional tDCS montage plus CCFES

Active unconventional tDCS montage plus CCFES

Sham tDCS plus CCFES

CCFES with Occupational Therapy

Study Details

Brief 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.

Conditions

Stroke

Upper Extremity Paresis

Hemiplegia

Study ID

NCT05866003

Start date

Jul 1, 2023

Status verified date

Sep, 2025

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 21 and ≤ 90
2. ≥ 6 and ≤ 24 months since first clinical hemorrhagic or nonhemorrhagic stroke
3. Able to follow 3-stage command
4. Able to remember 2 of 3 items after 30 minutes
5. Full volitional elbow extension/flexion and hand opening/closing of unaffected limb
6. Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice
7. Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment
8. Medically stable
9. ≥ 10° finger and wrist extension
10. Skin intact on hemiparetic arm, hand and scalp
11. Muscle contraction can be elicited with Transcranial Magnetic Stimulation
12. Unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the Medical Research Council (MRC) scale
13. Score of ≥1/14 and ≤ 11/14 on the hand section of the upper extremity Fugl-Meyer Assessment
14. While relaxed, surface NMES of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.

Exclusion Criteria:

1. Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, PD, SCI, TBI, MS).
2. Uncontrolled seizure disorder
3. Use of seizure lowering threshold medications and the discretion of the study physician
4. Cardiac pacemaker or other implanted electronic device
5. Pregnant
6. IM Botox injections in any UE muscle in the last 3 months
7. Insensate arm, forearm, or hand
8. Deficits in communication that interfere with reasonable study participation
9. Severely impaired cognition and communication
10. Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
11. Severe shoulder or hand pain (unable to position hand in the workspace without pain)

Study Design

Enrollment

63 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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.

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.

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.

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 and Locations

Central contacts

Locations

MetroHealth Medical Center

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

More Information

Sponsor

MetroHealth Medical Center

Last update posted

Sep 29, 2025

Last verified

Sep, 2025

Keywords

  • Stroke
  • Rehabilitation
  • Therapy
  • Electrical Stimulation
  • Brain stimulation
  • Hand
  • CCFES
  • Motor Cortex
  • TMS
  • Motor Recovery
  • Central Nervous System
  • CVA
  • Upper Limb

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MetroHealth Medical Center on 2025-09-29.