Functional Electrical Stimulation (FES) for Upper Extremity Recovery in Stroke

Completed

Phase 2 Results N/A

Eligibility Criteria

Inclusion Criteria

- Age 21-89
- Evidence of clinical symptoms from a hemorrhagic or nonhemorrhagic stroke with all symptoms from previous stroke(s) completely resolved
- Medically stable
- Less than 6 months post-stroke
- Intact skin on the hemiparetic side
- Able to follow 3-stage commands
- Able to recall 2/3 objects after 30 minutes
- Full passive ROM at the wrist and the thumb, index and long finger MCP joints on the affected side
- Presence of a detectable, volitionally-activated EMG signal from the paretic wrist or finger extensors (ECR or EDC)
- Affected wrist extensors ≤ 4 on MRC scale
- Score of ≤ 11/14 on Section C (hand) of UE portion of Fugl Meyer Assessment (FMA)
- Ability to tolerate NMES to the ECR and EDC for full wrist and finger extension
- Caregiver available to assist with the device every day (unless subject capable of using it independently

Exclusion Criteria

- History of ventricular arrythmias or any other arrythmias (i.e. fast atrial fibrillation, ventricular tachycardia, or supraventricular tachycardia) with hemodynamic instability
- History of other upper motor neuron lesion
- Absent sensation of the affected limb
- Pregnancy
- History of more than one seizure per month during the last year (or, since the stroke if no seizures prior to stroke)
- Discharge to a skilled nursing facility or long-term care facility (EXCEPTION: Subjects may be d/c'd to the 6A SNF unit at MetroHealth Medical Center)
- Uncompensated hemineglect
- Implanted stimulator (such as a pacemaker)
- Evidence of hand pain as defined by current metacarpophalangeal (MCP) joint pain upon palpation and/or wrist or MCP pain upon extension