Brain Computer Interface, Chronic Stroke Survivors With Plegic Hand, Hemiparesis, Spasticity as Sequela of Stroke, Stroke
Conditions
Keywords
Neurolutions, IpsiHand
Brief summary
BCI-REHAB was a randomized clinical trial comparing an at-home brain-computer interface therapy system versus an at-home exercise program for upper-extremity rehabilitation in the chronic phases of stroke. The purpose of the trial was to evaluate the efficacy of BCI-based therapy tested against standard exercise therapy and assess the potential for meaningful motor improvement in the home environment.
Detailed description
After meeting the inclusion criteria, all participants underwent an EEG evaluation to ensure that EEG features sufficient for device control could be detected. Participants who met the inclusion/exclusion criteria and passed the EEG test were randomly assigned (1:1) to either home-based BCI rehabilitation (BCI) or a Home Exercise rehabilitation regimen Program (HEP). Participants were instructed to use the device for home-based therapy sessions 1 hour per day, 5 days per week, for a continuous 12 weeks. During the therapy sessions, the system would guide the patient through a series of routines in which they would imagine opening and closing their affected hand. At the instant the BCI detected sensorimotor cortex EEG spectral features associated with imagined ipsilateral hand movements, the handpiece opened and closed the participant's hand in a three-finger pinch grip. Participants did not receive occupational or physical therapy services while participating in the self-directed BCI Therapy. Participants allocated to the HEP control group received a structured home exercise program designed to control for non-specific motor and sensory engagement associated with the intervention. They completed an in-person baseline assessment of function and an HEP training session with an OT. The program consisted of a customized set of range of motion and functional tasks targeting the hand, wrist, elbow, and shoulder. Participants were instructed to complete 1 hour of home exercise per day, 5 days per week, over the course of 12 weeks. The Primary outcome assessment was the in-person Upper Extremity Fugl-Meyer (UEFM) completed on day 1 (baseline) and after 12 weeks of participation.
Interventions
DEVICENeurolutions IpsiHand Upper Extremity Rehabilitation System
Electroencephalography (EEG)-driven upper extremity powered exerciser. An EEG-driven upper extremity powered exerciser is a non-invasive prescription device intended for rehabilitation by driving movement or exercise of an impaired upper extremity in response to the detection of purpose oriented electrical activity produced by the patient's brain.
OTHERHome Exercise rehabilitation regimen Program (HEP)
The program consisted of a customized set of range of motion and functional tasks targeting the hand, wrist, elbow, and shoulder. Participants were instructed to complete 1 hour of home exercise per day, 5 days per week, over the course of 12 weeks.
Sponsors
Neurolutions, Inc.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1:1 Randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Adults age (18-85) 2. Adults who sustained a CVA 3. Have upper extremity hemiparesis/hemiplegia 4. Participants who are not receiving Botox Injections for the upper extremity may be included. Should a participant be receiving Botox injections for the upper extremity, they may be included but Botox administration must be timed to coincide within a week of the beginning of training.
Exclusion criteria
1. Participants who are not receiving Botox Injections for the upper extremity may be included. Should a participant be receiving Botox injections for the upper extremity, they may be included but Botox administration must be timed to coincide within a week of the beginning of training. 2. Participants who are too cognitively impaired to understand the task or provide informed consent will be excluded. A Short-Blessed Test score of 8 or more will be excluded. 3. Participants who have contractures in the affected wrist and digits will be excluded, as the device will not comfortably fit. 4. Participants who have receptive aphasia and unable to follow written directions will be excluded. A score of 6 or less on the MS Aphasia Screening Test will be excluded. 5. Participants receiving any formal upper extremity therapy will be excluded. 6. Participants with ataxia apraxia or severe psychiatric illness (other than post stroke depression) will be excluded. 7. Participants who are pregnant or breast-feeding will be excluded. 8. Participants who have nerve or sensory impairment that may limit or interfere with their ability to sense pain will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upper Extremity Fugl-Meyer (UEFM) | 12 weeks | Assessment tool of upper extremity motor function. Lowest score 0, highest score 66. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlexandre Carter, MD, PhD
Washington University in Saint Louis
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age | 56.4 Years STANDARD_DEVIATION 16.2 |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black | 6 Participants |
| Race/Ethnicity, Customized Other/Unknown | 4 Participants |
| Race/Ethnicity, Customized White | 49 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 38 Participants |
| Upper Extremity Fugl-Meyer | 26.3 Units on a scale STANDARD_DEVIATION 17.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 42 |
| other Total, other adverse events | 0 / 43 | 0 / 42 |
| serious Total, serious adverse events | 0 / 43 | 0 / 42 |
Outcome results
None listed