BCI-FES Therapy for Stroke Rehabilitation

Prior treatment

• Implanted electronic device (e.g. pacemaker) or skull metallic implants (e.g. cranioplasty plate covering the leg motor area);
• A new symptomatic stroke occurs apart from the index stroke during the screening process and prior to randomization
• Received chemical denervation (eg Botox) to legs in the preceding 6 months, or expectation that chemical denervation will be administered to the leg prior to expected completion of the study
• Unable or unwilling to perform study procedures/therapy, or expectation of non-compliance with study procedures/therapy
• Receiving any outside concurrent physical therapy involving the lower extremities after enrollment in the study up to 1 month post treatment
• Concurrent enrollment in another investigational interventional study
• Concurrent use of FES orthosis for gait.
• A new symptomatic stroke occurs apart from the index stroke during the screening process and prior to randomization
  • If TMS Eligible (note that potential subjects who do not qualify for TMS will not be excluded from the main study, they will only be excluded from undergoing TMS procedures):
• TMS: Implanted medication pumps, intracardiac line, or central venous catheter
• TMS: Prior diagnosis of seizure or epilepsy
• TMS: Any electrical, mechanical, or magnetic implants

Other illness

• A major, active, coexistent medical, neurological (apart from stroke) or psychiatric disease (apart from stroke), including alcoholism or dementia, orthopedic injuries, that substantially affects gait. \*\*Because old orthopedic injuries may or may not affect gait, at the discretion of the site's study PI, exclusion criterion #2 related to orthopedic injuries can be waived if the injury was not on the stroke affected side and the joint/muscles are back to normal motor and range of motion function.
• A major medical disorder that substantially reduces the likelihood that a subject will be able to comply with all study procedures or safely complete study procedures. This includes, but not limited to documented serious cardiac conditions, serious pulmonary conditions, legal blindness, end stage renal or liver disease, pulmonary embolism or deep venous thrombosis.
• Deficits in communication that interfere with reasonable study participation: language or attention impairment (score\>1 on NIH Stroke Scale items 9 and 11, respectively)
• Significant cognitive impairment, defined as Montreal Cognitive Assessment score \< 22 (For those with aphasia: \*\*Because Montreal Cognitive Assessment scores may be difficult to interpret for patients with aphasia, at the discretion of the site's study PI, exclusion criterion #5 ("MoCA score cannot be \<22") can be waived)
• Any general medical condition and psychosocial situation that substantially interferes with reasonable participate in study appointments
• TMS: History of cortical stroke or other cortical lesion such as brain tumor
• TMS: History of neurosurgery
• TMS: Any current medications that affect seizure threshold such as tricyclic antidepressants and neuroleptics
• TMS: Unstable medical conditions

Other

• Resting systolic blood pressure above 170, diastolic blood pressure above 100 at screening and baseline evaluations
• Life expectancy \< 6 months
• Skin breakdown over electrical stimulation sites;
• Pregnancy;
• Significant pain (visual analog scale \>4), chest pain, or shortness of breath with walking.
• Non-English speaking, such that subject does not speak sufficient English to comply with study procedures
• Severe depression, defined as Geriatric Depression Scale Score \>11: \*\*Because Geriatric Depression scale scores may be difficult to interpret for some patients, at the discretion of the site's study PI, exclusion criterion #17 ("Geriatric Depression score cannot be \>11") can be waived)
• TMS: Metallic hardware on the scalp (e.g. vascular clips or cranioplasty mesh)
• TMS: uncontrolled Migraine headaches

• Age18-80 years inclusively at time of consent;
• Radiologically confirmed stroke, ischemic or intracerebral hemorrhage (ICH) in etiology, with day of onset at least 26 weeks prior to day of randomization
• Gait velocity\<0.8 m/s at screening and baseline visits.
• Foot-drop in affected limb as defined by dorsiflexion active range of motion (AROM) via goniometry in seated position foot dangling is less than passive range of motion and less than 15 degrees.
• Plantarflexors spasticity\<3 on modified Ashworth Scale;
• Can walk \>10 m (with or without ankle foot orthosis (AFO), and cane or walker permitted) at a supervised level;
• Can tolerate FES with pain no more than 4 on pain analog scale and has adequate muscle response of dorsiflexion ≥10 degrees;
• Passive Range of Motion at least 0 degrees ankle dorsiflexion in subtalar neutral or with FES