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

Last updated: September 23, 2025
Sponsor: MetroHealth Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Limb Spasticity

Stroke

Cerebral Ischemia

Treatment

CCFES with Occupational Therapy

Sham tDCS plus CCFES

Active unconventional tDCS montage plus CCFES

Clinical Study ID

NCT05866003
STUDY00000229
  • Ages 21-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 theworkspace for table-top task practice

  7. Patient must be able to sit unassisted in an armless straight-back chair for theduration 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 onthe Medical Research Council (MRC) scale

  13. Score of ≥1/14 and ≤ 11/14 on the hand section of the upper extremity Fugl-MeyerAssessment

  14. While relaxed, surface NMES of finger extensors and thumb extensors and/or abductorsproduces a functional degree of hand opening without pain.

Exclusion

Exclusion Criteria:

  1. Co-existing neurological condition other than prior stroke involving the hemipareticupper 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 studyphysician

  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

Total Participants: 63
Treatment Group(s): 4
Primary Treatment: CCFES with Occupational Therapy
Phase:
Study Start date:
July 01, 2023
Estimated Completion Date:
April 30, 2028

Study 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.

Connect with a study center

  • MetroHealth Medical Center

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • MetroHealth Medical Center

    Cleveland 5150529, Ohio 5165418 44109
    United States

    Active - Recruiting

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