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

NCT04724824 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-07-12

No results posted yet for this study

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

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • National Council of Science and Technology, Mexico

    collaborator OTHER

  • Hospital General Dr. Manuel Gea González

    collaborator OTHER_GOV

  • El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

    collaborator OTHER

  • Instituto Nacional de Rehabilitacion

    lead OTHER_GOV

Principal Investigators

  • Jessica Cantillo-Negrete, PhD · Instituto Nacional de Rehabilitacion (National Institute of Rehabilitation)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-16
Primary Completion
2024-06-24
Completion
2024-06-24

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04724824 on ClinicalTrials.gov