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)
| Registry | NCT04724824 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: triple, treatment |
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| Enrollment | 23 (Actual) |
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| Sponsor | Instituto Nacional de Rehabilitacion (Other gov); collaborators: National Council of Science and Technology, Mexico, Hospital General Dr. Manuel Gea González, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez |
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| Conditions | Stroke, Ischemic, Stroke |
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| Interventions | Brain-Computer Interface, Sham Brain-Computer Interface (Device) |
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| Dates | start 2021-03-16, primary completion 2024-06-24, completion 2024-06-24, first posted 2021-01-26, last updated 2024-07-12 |
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| Locations | 1 site in Mexico |
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Related Papers Related Patents Related Grants Related Experts
All trials for Stroke, Ischemic All trials for Stroke All trials of Brain-Computer Interface All trials of Sham Brain-Computer Interface
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Brain-Computer Interface controlled robotic feedback | Experimental | Device: Brain-Computer Interface | |
| Sham Brain-Computer Interface controlled robotic feedback | Sham comparator | Device: Sham Brain-Computer Interface | |
- Brain-Computer Interface (Device): Passive hand movement will be provided to patients' paralyzed hand by means of a robotic hand orthosis that will be activated by the brain-computer interface based on hand movement intention.
- Sham Brain-Computer Interface (Device): Passive hand movement will be provided to patients' paralyzed hand by means of a robotic hand orthosis which activation will be independent of the output of the brain-computer interface based on hand movement intention.
+Outcome measures
Primary outcomes
- Mean change from baseline in upper limb motor function on the Fugl-Meyer Assessment for the Upper Extremity [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 [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 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]: Blood-oxygen-level-dependent imaging will be analyzed to assess if there are changes in cortical activity compared to baseline.
- 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]: Motor Evoked Potentials parameters will reveal if there are changes of corticospinal excitability in both hemibodies compared to baseline
- 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]: Analysis of hand strength measurements will reveal if there were changes compared to baseline
+Eligibility
Sex: All, ages: 18 Years to any
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
+Locations (1)
| Facility | City | Country | Status |
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| Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation) | Tlalpan, Mexico City | Mexico | |
+Publications
- Results publication: Cantillo-Negrete J, Rodriguez-Garcia ME, Carrillo-Mora P, Arias-Carrion O, Ortega-Robles E, Galicia-Alvarado MA, Valdes-Cristerna R, Ramirez-Nava AG, Hernandez-Arenas C, Quinzanos-Fresnedo J, Pacheco-Gallegos MDR, Marin-Arriaga N, Carino-Escobar RI. The ReHand-BCI trial: a randomized controlled trial of a brain-computer interface for upper extremity stroke neurorehabilitation. Front Neurosci. 2025 Jun 18;19:1579988. doi: 10.3389/fnins.2025.1579988. eCollection 2025. PMID 40606836
- Results publication: Rodriguez-Garcia ME, Carino-Escobar RI, Carrillo-Mora P, Hernandez-Arenas C, Ramirez-Nava AG, Pacheco-Gallegos MDR, Valdes-Cristerna R, Cantillo-Negrete J. Neuroplasticity changes in cortical activity, grey matter, and white matter of stroke patients after upper extremity motor rehabilitation via a brain-computer interface therapy program. J Neural Eng. 2025 Mar 20;22(2). doi: 10.1088/1741-2552/adbebf. PMID 40064104
+Investigators