Back to resultsValidation of a Brain-Computer Interface for Stroke Neurological Upper Limb Rehabilitation
Primary Purpose
Stroke, Ischemic, Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Brain-Computer Interface
Sham Brain-Computer Interface
Sponsored by
About this trial
This is an interventional treatment trial for Stroke, Ischemic focused on measuring brain-computer interface, robotic orthosis, hemiparesis, motor rehabilitation
Eligibility Criteria
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
Sites / Locations
- Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Brain-Computer Interface controlled robotic feedback
Sham Brain-Computer Interface controlled robotic feedback
Arm Description
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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.
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
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
Full Information
NCT ID
NCT04724824
First Posted
January 22, 2021
Last Updated
February 17, 2023
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
1. Study Identification
Unique Protocol Identification Number
NCT04724824
Brief Title
Validation of a Brain-Computer Interface for Stroke Neurological Upper Limb Rehabilitation
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Stroke
Keywords
brain-computer interface, robotic orthosis, hemiparesis, motor rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Brain-Computer Interface controlled robotic feedback
Arm Type
Experimental
Arm Title
Sham Brain-Computer Interface controlled robotic feedback
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Brain-Computer Interface
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Brain-Computer Interface
Intervention Description
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 Outcome Measure Information:
Title
Mean change from baseline in upper limb motor function on the Fugl-Meyer Assessment for the Upper Extremity
Description
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
Time Frame
At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Title
Mean change from baseline in upper limb motor function on the Action Research Arm Test
Description
Analysis of changes on the Action Research Arm Test will reveal if there is a clinical significant motor function compared to baseline
Time Frame
At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Secondary Outcome Measure Information:
Title
Mean change from baseline in cortical activity measured with Functional Magnetic Resonance Imaging
Description
Blood-oxygen-level-dependent imaging will be analyzed to assess if there are changes in cortical activity compared to baseline.
Time Frame
At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Title
Mean change from baseline in corticospinal excitability measured with Transcranial Magnetic Stimulation
Description
Motor Evoked Potentials parameters will reveal if there are changes of corticospinal excitability in both hemibodies compared to baseline
Time Frame
At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Title
Mean change from baseline in grip strength measured with a dynamometer
Description
Analysis of hand strength measurements will reveal if there were changes compared to baseline
Time Frame
At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Cantillo-Negrete, PhD
Phone
+52 55 59991000
Ext
19008
Email
jcantillo@inr.gob.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Jimena Quinzaños-Fresnedo, PhD
Phone
+52 55 59991000
Ext
13410
Email
jimenaquinzanos@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Cantillo-Negrete, PhD
Organizational Affiliation
Instituto Nacional de Rehabilitacion (National Institute of Rehabilitation)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation)
City
Tlalpan
State/Province
Mexico City
ZIP/Postal Code
14389
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Cantillo-Negrete, PhD
Phone
+52 55 59991000
Ext
19008
Email
jcantillo@inr.gob.mx
First Name & Middle Initial & Last Name & Degree
Ruben I. Carino-Escobar, PhD
Phone
+52 55 59991000
Ext
19007
Email
ricarino@inr.gob.mx
First Name & Middle Initial & Last Name & Degree
Jessica Cantillo-Negrete, PhD
First Name & Middle Initial & Last Name & Degree
Ruben I. Carino-Escobar, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Validation of a Brain-Computer Interface for Stroke Neurological Upper Limb Rehabilitation
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