Validation of a Brain-Computer Interface for Stroke Neurological Upper Limb Rehabilitation

NCT04724824 | Completed DMC

• 1 other identifier: SALUD-2018-02-B-S-45803
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic; Stroke

Keywords

brain-computer interface; robotic orthosis; hemiparesis; motor rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• 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 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 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

Study Arms (2)

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

Interventions

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.

Brain-Computer Interface controlled robotic feedback

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.

Sham Brain-Computer Interface controlled robotic feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Rehabilitacion: lead
• National Council of Science and Technology, Mexico: collaborator
• Hospital General Dr. Manuel Gea González: collaborator
• El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez: collaborator

Study Sites (1)

Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation)

Tlalpan, Mexico City, 14389, Mexico

Location

Related Publications (2)

• 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 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.

  PMID: 40064104 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Paresis

Interventions

Brain-Computer Interfaces

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Jessica Cantillo-Negrete, PhD

  Instituto Nacional de Rehabilitacion (National Institute of Rehabilitation)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher in Medical Sciences

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 26, 2021
• Study Start: March 16, 2021
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Six months after publication
• Access Criteria: Researchers that make a request for access data and their request is approved by the National Institute of Rehabilitation Ethics Committee

Locations

ME (1)