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| Name | Class |
|---|---|
| National Council of Science and Technology, Mexico | OTHER |
| Hospital General Dr. Manuel Gea González | OTHER_GOV |
| El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brain-Computer Interface controlled robotic feedback | Experimental |
| |
| Sham Brain-Computer Interface controlled robotic feedback | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in upper limb motor function on the Fugl-Meyer Assessment for the Upper Extremity | 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 | 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 upper limb motor function on the Action Research Arm Test | Analysis of changes on the Action Research Arm Test will reveal if there is a clinical significant motor function compared to baseline | At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in cortical activity measured with Functional Magnetic Resonance Imaging | Blood-oxygen-level-dependent imaging will be analyzed to assess if there are changes in cortical activity compared to baseline. | At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Cantillo-Negrete, PhD | Instituto Nacional de Rehabilitacion (National Institute of Rehabilitation) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation) | Tlalpan | Mexico City | 14389 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40606836 | Derived | 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. | |
| 40064104 |
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De-identified individual participant data collected during the study will be available to other researchers from the principal investigator on reasonable request.
Six months after publication
Researchers that make a request for access data and their request is approved by the National Institute of Rehabilitation Ethics Committee
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D062207 | Brain-Computer Interfaces |
| ID | Term |
|---|---|
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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| 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. |
|
| Mean change from baseline in corticospinal excitability measured with Transcranial Magnetic Stimulation | Motor Evoked Potentials parameters will reveal if there are changes of corticospinal excitability in both hemibodies compared to baseline | 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 | Analysis of hand strength measurements will reveal if there were changes compared to baseline | At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset |
| Derived |
| 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |