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

• Sponsor: Instituto Nacional de Rehabilitacion (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04724824
• Collaborator: National Council of Science and Technology, Mexico (Other), Hospital General Dr. Manuel Gea González (Other), El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 29.5
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Ischemic; Stroke	Device: Brain-Computer Interface; Device: Sham Brain-Computer Interface	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Mar 16, 2021
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. 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.

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation)	Tlalpan	Mexico City	Mexico	14389

Sponsors and Collaborators

• Instituto Nacional de Rehabilitacion
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jessica Cantillo-Negrete, Researcher in Medical Sciences, Instituto Nacional de Rehabilitacion
• ClinicalTrials.gov Identifier: NCT04724824
• Other Study ID Numbers: SALUD-2018-02-B-S-45803
• First Posted: Jan 26, 2021
• Last Update Posted: Apr 29, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jessica Cantillo-Negrete, Researcher in Medical Sciences, Instituto Nacional de Rehabilitacion: brain-computer interface; robotic orthosis; hemiparesis; motor rehabilitation
• Additional relevant MeSH terms: Stroke; Ischemic Stroke

Study Results

No Results Posted as of Apr 29, 2022