Treatments for Recovery of Hand Function in Acute Stroke Survivors

Completed

Phase 1/2 Results

Eligibility Criteria

Inclusion Criteria

- Age 18 to 80
- Within 6 months of first clinical hemorrhagic or nonhemorrhagic stroke
- Cortical or subcortical stroke
- Unilateral upper extremity hemiparesis with severe finger extensor and flexor paresis (<= grade 4 on Medical Research Council (MRC) scale)
- Adequate movement of the shoulder and elbow to allow volitional positioning of the affected hand in the workspace.
- Surface NMES of finger and thumb extensors produces functional hand opening without pain
- Full volitional opening of the contralateral hand of the unimpaired side.
- Able to follow 3 stage commands
- Able to remember at least 2 of 3 items after 30 minutes
- Able to hear and respond (by opening the less affected hand) to auditory cues issued from the stimulator?
- Caregiver available and willing to help assist with the device and home regimen and ensure compliance
- Skin intact on hemiparetic arm
- Medically stable

Exclusion Criteria

- Insensate forearm and/or hand
- Edema of the affected forearm and/or hand
- History of potentially fatal cardiac arrhythmias.
- Cardiac pacemakers or any other implanted electronic systems
- Pregnant women
- Uncontrolled seizure disorder
- Severely impaired cognition or comprehension
- Uncompensated hemineglect
- Severe depression (>= 13 on Beck Depression Inventory Fast Screen)
- Ipsilateral lower motor neuron lesion
- Parkinson's Disease
- Spinal cord injury
- Traumatic brain injury
- Multiple sclerosis
- Lack of functional passive range of motion of the wrist or fingers of affected side
- Severe shoulder or hand pain (unable to volitionally position hand in the workspace without pain)
- Intramuscular botulinum toxin injections in upper extremity muscle in the last 3 months