NCT03857529Recruiting
Improving Stroke Motor Control With Non-invasive Brain Stimulation and Functional Electrical Stimulation
Contralaterally Controlled FES Plus Transcranial Direct Current Stimulation for Hand Motor Control After Stroke: A Pilot Study
Source: ClinicalTrials.gov · Last updated 29 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 26 Feb 2019
- Start date
- 1 Aug 2019
- Primary completion date
- 1 Aug 2028
- Lead sponsor
- MetroHealth Medical Center
- Diseases
- Stroke
- NCT number
- NCT03857529
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 1 Aug 2019 to the primary completion date, 1 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
- Metal implant in the head
Other illness
- 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
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MetroHealth Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.