NCT03857529 Improving Stroke Motor Control With Non-invasive Brain Stimulation and Functional Electrical Stimulation
| NCT ID | NCT03857529 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MetroHealth Medical Center |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2019-08-01 |
| Primary Completion | 2028-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2019-08-01 with a primary completion date of 2028-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This pilot study for stroke patients with chronic upper limb hemiplegia will examine the effects of non-invasive brain stimulation and neuromuscular electrical stimulation on hand motor control and corticospinal excitability. Specifically, this study will investigate the effects of timing and delivery of tDCS in conjunction with contralaterally controlled functional electrical stimulation.
Eligibility 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
Contact & Investigator
David A Cunningham, PhD
PRINCIPAL INVESTIGATOR
MetroHealth Medical Center
Frequently Asked Questions
Who can join the NCT03857529 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03857529 currently recruiting?
Yes, NCT03857529 is actively recruiting participants. Contact the research team at Dxc536@case.edu for enrollment information.
Where is the NCT03857529 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT03857529 clinical trial?
NCT03857529 is sponsored by MetroHealth Medical Center. The principal investigator is David A Cunningham, PhD at MetroHealth Medical Center. The trial plans to enroll 15 participants.
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