NCT05866003Recruiting
tDCS + CCFES-mediated Functional Task Practice for Post-stroke Upper Extremity Hemiplegia
tDCS During Contralaterally Controlled FES for Upper Extremity Hemiplegia
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)
After a stroke, it is very common to lose the ability to open the affected hand. Occupational and physical rehabilitation therapy (OT and PT) combined with non-invasive brain stimulation may help a person recover hand movement. The purpose of this study is to compare 3 non-invasive brain stimulation protocols combined with therapy to see if they result in different amounts of recovery of hand movement after a stroke.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 63 (estimated)
- First submitted
- 14 Apr 2023
- Start date
- 1 Jul 2023
- Primary completion date
- Apr 2028
- Lead sponsor
- MetroHealth Medical Center
- Diseases
- Stroke
- NCT number
- NCT05866003
What you commit to
- Study type: Interventional
- Planned participants: 63
- From 1 Jul 2023 to the primary completion date, Apr 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, PD, SCI, TBI, MS).
Other illness
- Uncontrolled seizure disorder
- Use of seizure lowering threshold medications and the discretion of the study physician
- Cardiac pacemaker or other implanted electronic device
Other
- Pregnant
- IM Botox injections in any UE muscle in the last 3 months
- Insensate arm, forearm, or hand
- Deficits in communication that interfere with reasonable study participation
- 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 and ≤ 90
- ≥ 6 and ≤ 24 months since first clinical hemorrhagic or nonhemorrhagic stroke
- Able to follow 3-stage command
- Able to 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 and wrist extension
- Skin intact on hemiparetic arm, hand and scalp
- Muscle contraction can be elicited with Transcranial Magnetic Stimulation
- Unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the Medical Research Council (MRC) scale
- Score of ≥1/14 and ≤ 11/14 on the hand section of the upper extremity Fugl-Meyer Assessment
- While relaxed, surface NMES of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.
Age in the registry: 21 years to 90 years · 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.