Validation of a Brain-Computer Interface for Neurorehabilitation With a Randomized Controlled Trial (Validación de Una Interfaz Cerebro-Computadora Para Rehabilitación Neurológica Por Medio de un Ensayo Clínico Controlado y Aleatorizado)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Mean change from baseline in upper limb motor function on the Fugl-Meyer Assessment for the Upper Extremity
Study Overview
Brief Summary
The study's main goal is to determine if clinical and physiological effects of a brain-computer interface intervention for the neurorehabilitation of stroke patients' upper limb are greater than the effects of a sham robotic feedback. For this purpose a randomized controlled trial will be performed to compare somatosensory sham robotic feedback with the same somatosensory feedback controlled with the brain-computer interface output.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of first ischemic stroke
- •Time since stroke onset higher than 3 months and lower than 24 months
- •Hand paresis
- •Normal or corrected to normal vision
- •Without previous diagnosed neurological diseases
Exclusion Criteria
- •Clinical diagnosis of severe aphasia
- •Clinical diagnosis of severe depression
- •Clinical diagnosis of severe attention deficits
- •Previous diagnosis of traumatic brain injury
- •Previous diagnosis of spinal cord injury
- •Previous diagnosis of peripheral nerve injury
Arms & Interventions
Brain-Computer Interface controlled robotic feedback
Intervention: Brain-Computer Interface (Device)
Sham Brain-Computer Interface controlled robotic feedback
Intervention: Sham Brain-Computer Interface (Device)
Outcomes
Primary Outcomes
Mean change from baseline in upper limb motor function on the Fugl-Meyer Assessment for the Upper Extremity
Time Frame: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Analysis of changes on the Fugl-Meyer Assessment for the Upper Extremity will reveal if there is a clinical significant sensorimotor function compared to baseline
Mean change from baseline in upper limb motor function on the Action Research Arm Test
Time Frame: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Analysis of changes on the Action Research Arm Test will reveal if there is a clinical significant motor function compared to baseline
Secondary Outcomes
- Mean change from baseline in corticospinal excitability measured with Transcranial Magnetic Stimulation(At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset)
- Mean change from baseline in cortical activity measured with Functional Magnetic Resonance Imaging(At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset)
- Mean change from baseline in grip strength measured with a dynamometer(At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset)
Investigators
Jessica Cantillo-Negrete
Researcher in Medical Sciences
Instituto Nacional de Rehabilitacion