Improving Stroke Motor Control With Non-invasive Brain Stimulation and Functional Electrical Stimulation
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Stroke, Rehabilitation, Hand
In brief
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.
Key facts
- Study ID
- NCT03857529
- Run by
- MetroHealth Medical Center
- People needed
- 15
- Starts
- 2019-08-01
- Expected to finish
- 2028-08-01
- Last updated by the study team
- 2025-09-29
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- MetroHealth Medical Center — Cleveland, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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