Improving hand motor control in stroke patients using brain and electrical stimulation
Contralaterally Controlled FES Plus Transcranial Direct Current Stimulation for Hand Motor Control After Stroke: A Pilot Study
This study is testing if combining brain stimulation with electrical stimulation can help stroke patients improve their hand movement and control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | MetroHealth Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT03857529 on ClinicalTrials.gov |
What this trial studies
This pilot study focuses on stroke patients with chronic upper limb hemiplegia and aims to evaluate the effects of non-invasive brain stimulation combined with functional electrical stimulation on hand motor control and corticospinal excitability. The study will specifically investigate the timing and delivery of transcranial direct current stimulation (tDCS) alongside contralaterally controlled electrical stimulation. Participants will undergo assessments to determine their eligibility based on specific motor function criteria and will receive targeted interventions to enhance their rehabilitation outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older who have experienced a stroke at least six months prior and have specific motor function capabilities.
Not a fit: Patients with severe motor impairments or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve hand motor control and rehabilitation outcomes for stroke patients.
How similar studies have performed: Other studies have shown promise with similar non-invasive brain stimulation techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 21 2. ≥ 6 months since first clinical hemorrhagic or nonhemorrhagic stroke 3. Able to follow 3-stage commands and remember 2 of 3 items after 30 minutes 4. Full volitional elbow extension/flexion and hand opening/closing of unaffected limb 5. Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice 6. Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment 7. Medically stable 8. ≥ 10° finger extension 9. Unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the manual muscle test AND a score of ≥1 and ≤ 11/14 on the hand section of the upper extremity Fugl-Meyer Assessment 10. Skin intact on hemiparetic arm, hand and scalp 11. While relaxed, surface neuromuscular electrical stimulation of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain. 12. No significant visual or hearing impairment Exclusion Criteria: 1. Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, Parkinson's disease, spinal cord injury, traumatic brain injury, multiple sclerosis). 2. Uncontrolled seizure disorder 3. Use of seizure lowering threshold medications at the discretion of the study physician (Dr. Rich Wilson) 4. Cardiac pacemaker or other implanted electronic device and/or stent 5. Pregnant 6. Intramuscular botox injections in any upper extremity muscle in the last 3 months 7. Insensate arm, forearm, or hand 8. Severely impaired cognition and communication 9. Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation) 10. Severe shoulder or hand pain (unable to position hand in the workspace without pain) 11. Metal implant in the head
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
- Study coordinator: David A Cunningham, PhD
- Email: Dxc536@case.edu
- Phone: (216) 957-3349
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.