Status:
RECRUITING
Improving Stroke Motor Control With Non-invasive Brain Stimulation and Functional Electrical Stimulation
Lead Sponsor:
MetroHealth Medical Center
Conditions:
Stroke
Rehabilitation
Eligibility:
All Genders
21+ years
Phase:
NA
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 co...
Eligibility Criteria
Inclusion
- Age ≥ 21
- ≥ 6 months since first clinical hemorrhagic or nonhemorrhagic stroke
- Able to follow 3-stage commands and remember 2 of 3 items after 30 minutes
- Full volitional elbow extension/flexion and hand opening/closing of unaffected limb
- Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice
- Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment
- Medically stable
- ≥ 10° finger extension
- 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
- Skin intact on hemiparetic arm, hand and scalp
- While relaxed, surface neuromuscular electrical stimulation of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.
- No significant visual or hearing impairment
Exclusion
- 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).
- Uncontrolled seizure disorder
- Use of seizure lowering threshold medications at the discretion of the study physician (Dr. Rich Wilson)
- Cardiac pacemaker or other implanted electronic device and/or stent
- Pregnant
- Intramuscular botox injections in any upper extremity muscle in the last 3 months
- Insensate arm, forearm, or hand
- Severely impaired cognition and communication
- Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
- Severe shoulder or hand pain (unable to position hand in the workspace without pain)
- Metal implant in the head
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03857529
Start Date
August 1 2019
End Date
August 1 2028
Last Update
September 29 2025
Active Locations (1)
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1
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109