Phase
Condition
Limb Spasticity
Stroke
Cerebral Ischemia
Treatment
CCFES with Occupational Therapy
Sham tDCS plus CCFES
Active unconventional tDCS montage plus CCFES
Clinical Study ID
Ages 21-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 theworkspace for table-top task practice
Patient must be able to sit unassisted in an armless straight-back chair for theduration 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 onthe Medical Research Council (MRC) scale
Score of ≥1/14 and ≤ 11/14 on the hand section of the upper extremity Fugl-MeyerAssessment
While relaxed, surface NMES of finger extensors and thumb extensors and/or abductorsproduces a functional degree of hand opening without pain.
Exclusion
Exclusion Criteria:
Co-existing neurological condition other than prior stroke involving the hemipareticupper limb (e.g., peripheral nerve injury, PD, SCI, TBI, MS).
Uncontrolled seizure disorder
Use of seizure lowering threshold medications and the discretion of the studyphysician
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)
Study Design
Study Description
Connect with a study center
MetroHealth Medical Center
Cleveland, Ohio 44109
United StatesSite Not Available
MetroHealth Medical Center
Cleveland 5150529, Ohio 5165418 44109
United StatesActive - Recruiting

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