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

Not Applicable

Completed

• Conditions: Stroke, Ischemic; Stroke
• Interventions: Device: Sham Brain-Computer Interface; Device: Brain-Computer Interface

• Registration Number: NCT04724824
• Lead Sponsor: Instituto Nacional de Rehabilitacion

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-22
• Study First Submitted QC: 2021-01-22
• Study First Posted: 2021-01-26
• Study Start: 2021-03-16
• Primary Completion: 2024-06-24
• Study Completion: 2024-06-24
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Brain-Computer Interface controlled robotic feedback	Sham Brain-Computer Interface	-
Brain-Computer Interface controlled robotic feedback	Brain-Computer Interface	-

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in upper limb motor function on the Fugl-Meyer Assessment for the Upper Extremity	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
Mean change from baseline in upper limb motor function on the Action Research Arm Test	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 Outcome Measures

Name	Time	Method
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	Motor Evoked Potentials parameters will reveal if there are changes of corticospinal excitability in both hemibodies compared to baseline
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	Blood-oxygen-level-dependent imaging will be analyzed to assess if there are changes in cortical activity compared to baseline.
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	Analysis of hand strength measurements will reveal if there were changes compared to baseline

Trial Locations

Locations (1)

Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation); 🇲🇽 Tlalpan, Mexico City, Mexico