Combining brain stimulation with therapy to improve hand movement after stroke
tDCS During Contralaterally Controlled FES for Upper Extremity Hemiplegia
This study is testing whether different types of brain stimulation combined with therapy can help stroke survivors improve their hand movement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 21 Years to 90 Years |
| Sex | All |
| Sponsor | MetroHealth Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05866003 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of three different non-invasive brain stimulation protocols combined with occupational therapy for stroke survivors experiencing upper extremity hemiplegia. Participants will be randomly assigned to receive either conventional tDCS, unconventional tDCS, or sham tDCS alongside contralaterally controlled functional electrical stimulation (CCFES) during a 12-week treatment period. The study will include a 6-month follow-up to assess recovery outcomes. All participants, therapists, and assessors will be blinded to the treatment received to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 90 who have experienced a stroke 6 to 24 months prior and have specific functional capabilities.
Not a fit: Patients with severe cognitive impairments or those unable to follow commands may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance recovery of hand movement in stroke survivors, improving their quality of life.
How similar studies have performed: This study represents a novel approach, as it is the first randomized clinical trial combining tDCS with CCFES for this purpose.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Cleveland, Ohio
- MetroHealth Medical Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: David A Cunningham, PhD — MetroHealth Medical Center and Case Western Reserve University
- Study coordinator: Amy Friedl, MS,OTR/L
- Email: strokeresearch@metrohealth.org
- Phone: 216-957-3598
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.