BCI-FES Therapy for Stroke Rehabilitation
Keywords
Abstract
Description
Preliminary research indicates that applying this technique to foot weakness after stroke is safe and may improve walking function. Hence, this warrants further investigation to: 1. determine if BCI-FES therapy can provide lasting gains in walking in chronic stroke patients; 2. determine what factors influence BCI-FES therapy; and 3. explicitly elucidate the underlying neural repair mechanisms. First, a Phase II clinical trial in patients with foot drop due to chronic stroke will compare the effect of BCIFES dorsiflexion therapy to that of dose- and intensity-matched standard physical therapy (Aim 1). Comparing the improvement in walking speed and other secondary outcome measures between the two groups will test if BCI-FES therapy provides functional and neurological gains beyond those of standard physical therapy. The relationship between the patient baseline characteristics (walking speed, ankle function, stimulated muscle responses, brain wave features, sensation) and the outcomes will determine what features influence responsiveness to BCI-FES dorsiflexion therapy (Aim 2). Finally, the underlying mechanism driving the improvements of BCI-FES will be studied (Aim 3). Determining that BCI-FES therapy can provide improvements beyond that of standard therapy may lead to a new treatment for stroke patients. The underlying mechanism can inform the design of future physical therapy techniques or improve current ones. Finally, BCI-FES therapy may ultimately become a novel form of physical therapy to reduce post-stroke disability, and in turn reduce the public health burden of stroke.
Dates
| Last Verified: | 05/31/2020 |
| First Submitted: | 02/11/2020 |
| Estimated Enrollment Submitted: | 02/18/2020 |
| First Posted: | 02/19/2020 |
| Last Update Submitted: | 06/17/2020 |
| Last Update Posted: | 06/21/2020 |
| Actual Study Start Date: | 04/16/2020 |
| Estimated Primary Completion Date: | 02/14/2023 |
| Estimated Study Completion Date: | 09/14/2023 |
Condition or disease
Intervention/treatment
Device: BCI-FES dorsiflexion therapy with physiotherapy
Behavioral: BCI-FES dorsiflexion therapy with physiotherapy
Behavioral: Dose-and intensity-matched physiotherapy
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: BCI-FES dorsiflexion therapy with physiotherapy Subjects will undergo placement of an EEG cap using standard technique connected to our custom BCI system. Subjects will provide 5 min of training EEG data as they engage in alternating epochs of idling and attempted foot dorsiflexion (of the paretic side). In the online phase, the subjects will perform 20-25 BCI-FES runs. A total of 12 sessions will be performed at a rate of 3x/week (over 4 weeks). Each BCI-FES therapy session will be followed by 1 hour of conventional physiotherapy.
Conventional Physical Therapy: This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises. | Device: BCI-FES dorsiflexion therapy with physiotherapy 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. The automated software will analyze the data to generate and calibrate a BCI decoder. In the online phase, the subjects will perform 20-25 BCI-FES runs. In each run, subjects will follow 10 alternating epochs of 10-s long idling/dorsiflexion textual cues, and respond by either idling or attempting dorsiflexion to elicit BCI-FES mediated contractions of the TA muscle. |
| Experimental: Dose-and intensity-matched physiotherapy Conventional Physical Therapy: This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises. A total of 12 sessions will be performed at 3x/week.
In the dose-matched control group (Group 2), it will be 2 hours/session. | Behavioral: Dose-and intensity-matched physiotherapy This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises. A total of 12 sessions will be performed at 3x/week. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: 1. Age18-80 years inclusively at time of consent; 2. Radiologically confirmed first unilateral stroke, ischemic or intracranial hemorrhage (ICH) in etiology, with day of onset 26-104 weeks prior to day of randomization 3. Gait velocity<0.8 m/s at screening and baseline visits; 4. 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. 5. Plantarflexors spasticity<3 on modified Ashworth Scale; 6. Can walk >10 m (no ankle foot orthosis (AFO), but cane or walker permitted) at a supervised level; 7. Can tolerate FES with pain no more than 4 on pain analog scale and has adequate muscle response of TA dorsiflexion ≥10 degrees; 8. Passive Range of Motion at least +10 degrees ankle dorsiflexion in subtalar neutral Exclusion Criteria: 1. 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. 2. 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. 3. Resting systolic blood pressure above 170, diastolic blood pressure above 100 at screening and baseline evaluations 4. Implanted electronic device (e.g. pacemaker) or skull metallic implants (e.g. cranioplasty plate); 5. Deficits in communication that interfere with reasonable study participation: language or attention impairment (score>1 on NIH Stroke Scale items 9 and 11, respectively) 6. 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)6. A new symptomatic stroke occurs apart from the index stroke during the screening process and prior to randomization 7. Life expectancy < 6 months 8. Skin breakdown over electrical stimulation sites; 9. Received chemical denervation (eg Botox) to arms, legs, or trunk in the preceding 6 months, or expectation that chemical denervation will be administered to the arm, leg, or trunk prior to expected completion of the study 10. Unable or unwilling to perform study procedures/therapy, or expectation of non-compliance with study procedures/therapy 11. Pregnancy; 12. Significant pain (visual analog scale >4), chest pain, or shortness of breath with walking. 13. Receiving any outside concurrent physical therapy 14. Any general medical condition and psychosocial situation that substantially interferes with reasonable participate in study appointments 15. Non-English speaking, such that subject does not speak sufficient English to comply with study procedures 16. Concurrent enrollment in another investigational interventional study 17. Severe depression, defined as Geriatric Depression Scale Score >11 18. Prior or concurrent use of FES orthosis for gait. 19. 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): 20. TMS: Metallic hardware on the scalp (e.g. vascular clips or cranioplasty mesh) 21. TMS: Implanted medication pumps, intracardiac line, or central venous catheter 22. TMS: History of cortical stroke or other cortical lesion such as brain tumor 23. TMS: Prior diagnosis of seizure or epilepsy 24. TMS: Any electrical, mechanical, or magnetic implants 25. TMS: History of neurosurgery 26. TMS: uncontrolled Migraine headaches 27. TMS: Any current medications that affect seizure threshold such as tricyclic antidepressants and neuroleptics 28. TMS: Unstable medical conditions |
Outcome
Primary Outcome Measures
1. Change in Gait Velocity [Change in Gait velocity from Screening to 1 month]
Secondary Outcome Measures
1. Change in Dorsiflexion Range of Motion [Change in Dorsiflexion Range of Motion from Screening to 1 month]
2. Change Leg Motor Fugl-Meyer score (Leg FM) [Change Leg Motor Fugl-Meyer score (Leg FM) from Baseline to 1 month]
3. Change Gait Endurance (Six minute walk test: 6MWT) [Change Gait Endurance (Six minute walk test: 6MWT) from Screening to 1 month]
4. Change in Fall Frequency [Change in Fall Frequency from Screening to 1 month]
5. Change in EEG Map (Electroencephalogram) [Change in EEG Map (Electroencephalogram) from Baseline to 1 month]
