Validation of a Brain-Computer Interface for Stroke Neurological Upper Limb Rehabilitation
NCT ID: NCT04724824
Last Updated: 2024-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2021-03-16
2024-06-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Brain-Computer Interface controlled robotic feedback
Brain-Computer Interface
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 controlled robotic feedback
Sham Brain-Computer Interface
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.
Interventions
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Brain-Computer Interface
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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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
Instituto Nacional de Rehabilitacion
OTHER_GOV
Responsible Party
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Jessica Cantillo-Negrete
Researcher in Medical Sciences
Principal Investigators
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Jessica Cantillo-Negrete, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Rehabilitacion (National Institute of Rehabilitation)
Locations
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Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation)
Tlalpan, Mexico City, Mexico
Countries
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References
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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.
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.
Other Identifiers
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SALUD-2018-02-B-S-45803
Identifier Type: -
Identifier Source: org_study_id
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