tDCS + CCFES-mediated Functional Task Practice for Post-stroke Upper Extremity Hemiplegia
tDCS During Contralaterally Controlled FES for Upper Extremity Hemiplegia
Who can join
Ages 21 to 90 · All sexes
Full eligibility criteria
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)
About the study
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.
What is being tested
- Active conventional tDCS montage plus CCFES (device)
- Active unconventional tDCS montage plus CCFES (device)
- Sham tDCS plus CCFES (device)
- CCFES with Occupational Therapy (behavioral)
Sponsor: MetroHealth Medical Center · Participants: 63 · Started: Jul 1, 2023
Contact the study team
- Amy Friedl, MS,OTR/L · Phone: 216-957-3598
- David Cunningham, PhD · Phone: 216-957-3349
Official record on ClinicalTrials.gov — NCT05866003
Locations in the U.S.
| Ohio | MetroHealth Medical Center, Cleveland |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.