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

Stroke Clinical Trial

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04724824
• Other study ID #: SALUD-2018-02-B-S-45803
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2021
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: Instituto Nacional de Rehabilitacion
• Contact: Jessica Cantillo-Negrete, PhD
• Phone: +52 55 59991000
• Email: jcantillo[@]inr.gob.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

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 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.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation)	Tlalpan	Mexico City

Sponsors (4)

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

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Mean change from baseline in cortical activity measured with Functional Magnetic Resonance Imaging	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
Secondary	Mean change from baseline in corticospinal excitability measured with Transcranial Magnetic Stimulation	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
Secondary	Mean change from baseline in grip strength measured with a dynamometer	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