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Completed

NCT Number: NCT04724824

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Tlalpan, Mexico City, 14389, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Rehabilitacion

Other Gov

Collaborators

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

Registry information

Official study title

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)

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 26, 2021
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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