tDCS + CCFES-mediated Functional Task Practice for Post-stroke Upper Extremity Hemiplegia

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Stroke, Upper Extremity Paresis, Hemiplegia

In brief

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.

Key facts

Study ID

NCT05866003

Run by

MetroHealth Medical Center

People needed

63

Starts

2023-07-01

Expected to finish

2028-04-01

Last updated by the study team

2025-09-29

Who can join

Age: 21 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• 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)

Where it is running

• MetroHealth Medical Center — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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