BCI-FES Therapy for Stroke Rehabilitation (NCT04279067) | Clinical Trial Compass
CompletedNot Applicable
BCI-FES Therapy for Stroke Rehabilitation
United States62 participantsStarted 2020-05-15
Plain-language summary
There are over 7 million stroke survivors in the US alone, with approximately 795,000 new cases annually. Despite the best available physiotherapy, 30-60% of stroke survivors remain affected by difficulty walking, with foot weakness often being the main cause. Given that post-stroke gait impairments remain poorly addressed, new methods that can provide lasting improvements are necessary. Brain-computer interface (BCI) technology may be one such novel approach. BCI technology enables "direct brain control" of external devices such as assistive devices and prostheses by translating brain waves into control signals. When BCI systems are integrated with functional electrical stimulation (FES) systems, they can be used to deliver a novel physical therapy to improve movement after stroke. BCI-FES systems are hypothesized to stimulate recovery after stroke beyond that of conventional physical therapy.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
What they're measuring
1
Gait Velocity
Timeframe: Baseline to End of Therapy (4 weeks after initiation of therapy)
. 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.
✕. Resting systolic blood pressure above 170, diastolic blood pressure above 100 at screening and baseline evaluations
✕. Implanted electronic device (e.g. pacemaker) or skull metallic implants (e.g. cranioplasty plate covering the leg motor area);
✕. 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)
✕. A new symptomatic stroke occurs apart from the index stroke during the screening process and prior to randomization