NCT05866003 · MetroHealth Medical Center
tDCS + CCFES-mediated Functional Task Practice for Post-stroke Upper Extremity Hemiplegia
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, PD, SCI, TBI, MS).
- Uncontrolled seizure disorder
- Use of seizure lowering threshold medications and the discretion of the study physician
- Cardiac pacemaker or other implanted electronic device
- 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)
Where
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 29, 2025 · Source of record for eligibility and locations