Ischemic Stroke Clinical Trial
Official title:
Brain Computer Interface - Functional Electrical Stimulation (BCI-FES) Therapy for Stroke Rehabilitation
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.
Status | Recruiting |
Enrollment | 66 |
Est. completion date | October 15, 2024 |
Est. primary completion date | July 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Age18-80 years inclusively at time of consent; 2. Radiologically confirmed stroke, ischemic or intracerebral hemorrhage (ICH) in etiology, with day of onset at least 26 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 (with or without ankle foot orthosis (AFO), and 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 dorsiflexion =10 degrees; 8. Passive Range of Motion at least 0 degrees ankle dorsiflexion in subtalar neutral or with FES 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. **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. 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 covering the leg motor area); 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) 7. A new symptomatic stroke occurs apart from the index stroke during the screening process and prior to randomization 8. Life expectancy < 6 months 9. Skin breakdown over electrical stimulation sites; 10. 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 11. Unable or unwilling to perform study procedures/therapy, or expectation of non-compliance with study procedures/therapy 12. Pregnancy; 13. Significant pain (visual analog scale >4), chest pain, or shortness of breath with walking. 14. Receiving any outside concurrent physical therapy involving the lower extremities after enrollment in the study up to 1 month post treatment 15. Any general medical condition and psychosocial situation that substantially interferes with reasonable participate in study appointments 16. Non-English speaking, such that subject does not speak sufficient English to comply with study procedures 17. Concurrent enrollment in another investigational interventional study 18. 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) 19. Concurrent use of FES orthosis for gait. 20. 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): 21. TMS: Metallic hardware on the scalp (e.g. vascular clips or cranioplasty mesh) 22. TMS: Implanted medication pumps, intracardiac line, or central venous catheter 23. TMS: History of cortical stroke or other cortical lesion such as brain tumor 24. TMS: Prior diagnosis of seizure or epilepsy 25. TMS: Any electrical, mechanical, or magnetic implants 26. TMS: History of neurosurgery 27. TMS: uncontrolled Migraine headaches 28. TMS: Any current medications that affect seizure threshold such as tricyclic antidepressants and neuroleptics 29. TMS: Unstable medical conditions |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Irvine - Sue & Bill Gross Stem Cell Research Center | Irvine | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Irvine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Gait Velocity | Gait velocity will be assessed by measuring the time to traverse the middle 6 m of a 10-m walkway (5 repetitions/assessment). Scores are reported in meters/second with higher scores indicating better function. | Change in Gait velocity from Screening to 1 month | |
Secondary | Change in Dorsiflexion Range of Motion | The paretic foot will be placed in an articulated brace which maintains the ankle at neutral during idling, while fixing the tibia perpendicular to the ground and the femur horizontal to the ground. The brace will be instrumented with an electro-goniometer and torque meter to automatically measure the maximum dorsiflexion which ranges from 0-20 degrees with higher score indicating better function | Change in Dorsiflexion Range of Motion from Screening to 1 month | |
Secondary | Change Leg Motor Fugl-Meyer score (Leg FM) | Assessed according to the FM rating system which is an impairment scale of hemiparesis; scores range from 0-34 with higher scores indicating less impairment | Change Leg Motor Fugl-Meyer score (Leg FM) from Baseline to 1 month | |
Secondary | Change Gait Endurance (Six minute walk test: 6MWT) | The distance walked over 6 minutes. Score is reported in meters and higher score indicates better function. | Change Gait Endurance (Six minute walk test: 6MWT) from Screening to 1 month | |
Secondary | Change in Fall Frequency | Number of falls experienced weekly. Score is reported in numbers with lower scores indicating better function. | Change in Fall Frequency from Screening to 1 month | |
Secondary | Change in EEG Map (Electroencephalogram) | Subjects will undergo 64-channel EEG recording as they engage in 100 alternating 10-s long epochs of idling and attempted dorsiflexion. The EEG ERD/ERS, defined as the drop/rise in alpha (8-12 Hz) and beta (13-30 Hz) band power during attempted dorsiflexion (compared to idling) will be calculated and averaged over all epochs and across all channels. Change in ERD and ERS will be express as signal-to-noise ratio, with higher values indicating improved function. | Change in EEG Map (Electroencephalogram) from Baseline to 1 month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Recruiting |
NCT05518305 -
Platelet Expression of FcγRIIa and Arterial Hemodynamics to Predict Recurrent Stroke in Intracranial Atherosclerosis
|
||
Recruiting |
NCT06029959 -
Stroke and CPAP Outcome Study 3
|
N/A | |
Recruiting |
NCT03728738 -
Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke
|
Phase 3 | |
Terminated |
NCT03396419 -
IMPACT- 24col Collateral Blood Flow Assessment Following SPG Stimulation in Acute Ischemic Stroke (ImpACT-24B Sub-Study)
|
||
Recruiting |
NCT05065216 -
Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)
|
Phase 2/Phase 3 | |
Recruiting |
NCT04897334 -
Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke
|
N/A | |
Not yet recruiting |
NCT06032819 -
Differentiating Between Brain Hemorrhage and Contrast
|
||
Not yet recruiting |
NCT06026696 -
Cohort of Neurovascular Diseases Treated in the Acute Phase and Followed at Lariboisière
|
||
Recruiting |
NCT02910180 -
Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders
|
||
Withdrawn |
NCT01866189 -
Identification of Hypoxic Brain Tissues by F-MISO PET in Acute Ischemic Stroke
|
N/A | |
Completed |
NCT02922452 -
A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects
|
Phase 1 | |
Completed |
NCT03554642 -
Walkbot Robotic Training for Improvement in Gait
|
Phase 3 | |
Recruiting |
NCT03041753 -
Reperfusion Injury After Stroke Study
|
N/A | |
Completed |
NCT02549846 -
AdminiStration of Statin On Acute Ischemic stRoke patienT Trial
|
Phase 4 | |
Completed |
NCT02610803 -
Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke
|
N/A | |
Completed |
NCT01678534 -
Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial
|
Phase 2 | |
Completed |
NCT02924168 -
Radial Shock Waves for Functional Disability in Stroke
|
N/A |