tDCS + CCFES-mediated Functional Task Practice for Post-stroke Upper Extremity Hemiplegia
Stroke, Upper Extremity Paresis, Hemiplegia
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Rehabilitation, Therapy, Electrical Stimulation, Brain stimulation, Hand, CCFES, Motor Cortex, TMS, Motor Recovery, Central Nervous System, CVA, Upper Limb
Eligibility Criteria
Inclusion Criteria: Age ≥ 21 and ≤ 90 ≥ 6 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 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)
Sites / Locations
- MetroHealth Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Sham Comparator
Active conventional tDCS plus CCFES
Active unconventional tDCS plus CCFES
Sham tDCS plus CCFES
The conventional tDCS montages involves placing the surface anode electrode on the scalp of the lesioned hemisphere and the surface cathode electrode on the scalp of the non-lesioned hemisphere. TDCS will deliver a low current while participants are undergoing CCFES-mediated functional task practice.
The unconventional tDCS montages involves placing the surface anode electrode on the scalp of the non-lesioned hemisphere and the surface cathode electrode on the scalp of the lesioned hemisphere. TDCS will deliver a low current while participants are undergoing CCFES-mediated functional task practice.
The sham tDCS montages involves placing the surface electrodes on the scalp over the lesioned and the non-lesioned hemisphere. TDCS will not be delivered during CCFES-mediated functional task practice.