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

July 11, 2024 updated by: Jessica Cantillo-Negrete, Instituto Nacional de Rehabilitacion

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Mexico City
      • Tlalpan, Mexico City, Mexico, 14389
        • Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brain-Computer Interface controlled robotic feedback
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.
Sham Comparator: Sham Brain-Computer Interface controlled robotic feedback
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline in upper limb motor function on the Fugl-Meyer Assessment for the Upper Extremity
Time Frame: 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
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
Time Frame: 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
At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline in cortical activity measured with Functional Magnetic Resonance Imaging
Time Frame: 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.
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
Time Frame: 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
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
Time Frame: 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
At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Rehabilitacion

Collaborators

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

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2021

Primary Completion (Actual)

June 24, 2024

Study Completion (Actual)

June 24, 2024

Study Registration Dates

First Submitted

January 22, 2021

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 26, 2021

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 11, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SALUD-2018-02-B-S-45803

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data collected during the study will be available to other researchers from the principal investigator on reasonable request.

IPD Sharing Time Frame

Six months after publication

IPD Sharing Access Criteria

Researchers that make a request for access data and their request is approved by the National Institute of Rehabilitation Ethics Committee

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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