Back to resultsEfficacy of a Brain-Computer Interface Controlled Functional Electrical Stimulation Therapy for Spinal Cord Injury Neurorehabilitation
Primary Purpose
Cervical Spinal Cord Injury
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 Cervical Spinal Cord Injury focused on measuring brain-computer interface, functional electrical stimulation, motor rehabilitation, tetraplegia
Eligibility Criteria
Inclusion Criteria:
- Spinal Cord Injury at neurological levels C6 or C7
- American Spinal Injury Association (ASIA) classification A, B, C or D
- Upper limb spasticity of less or equal to +1 measured with the Modified Ashworth Scale
- Time since disease onset of more than 6 months and less than 60 months
- Normal or corrected to normal vision
Exclusion Criteria:
- Severe attention deficits
- Previous diagnosis of traumatic brain injury
- Previous diagnosis of peripheral nerve injury
- Previous stroke diagnosis
- Previous diagnosis of neurodegenerative diseases
- History of fractures in upper extremities
- Skin lesions
- Contractures in upper extremities that hamper mobility
- Excessive muscle spasms
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 functional electrical stimulation feedback
Sham Brain-Computer Interface controlled functional electrical stimulation feedback
Arm Description
Outcomes
Primary Outcome Measures
Action Research Arm Test (ARAT)
Change of upper limbs function. Scale ranges from 0 to 57 points for each upper limb. A higher score means a better upper limb function.
Upper Extremity Motor Score (UEMS)
Change of upper limbs function. Scale ranges from 0 to 50 points if both upper limbs are assessed. A higher score means a better upper limb function.
Capabilities of Upper Extremities Questionnaire (CUE-Q)
Change of the functional limitation in tetraplegia. Scale ranges from 32 to 224 points if both upper limbs are assessed. A higher score means less functional limitation outcome.
Secondary Outcome Measures
Spinal Cord Independence Measure III (SCIM-III)
Change of achievements of daily function. Scale ranges from 0 to 100 points. A higher score means a better capacity to perform activities of the daily living.
Life Satisfaction Questionnaire 9 (LISAT-9)
Change of life satisfaction. Scale ranges from 0 to 54 points. A higher score is expected with a better life satisfaction.
Full Information
NCT ID
NCT05343130
First Posted
April 18, 2022
Last Updated
September 27, 2023
Sponsor
Instituto Nacional de Rehabilitacion
Collaborators
Instituto Tecnologico y de Estudios Superiores de Monterey
1. Study Identification
Unique Protocol Identification Number
NCT05343130
Brief Title
Efficacy of a Brain-Computer Interface Controlled Functional Electrical Stimulation Therapy for Spinal Cord Injury Neurorehabilitation
Official Title
Efficacy of a Therapy With Brain-Computer Interface Controlled Functional Electrical Stimulation for Neurorehabilitation of Patients With Spinal Cord Injury (Eficacia de Una Terapia Con estimulación eléctrica Funcional Controlada Con Interfaz Cerebro-computadora Para neurorrehabilitación de Pacientes Con lesión Medular)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Rehabilitacion
Collaborators
Instituto Tecnologico y de Estudios Superiores de Monterey
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 the efficacy of a therapy with brain-computer interface controlled functional electrical stimulation for neurorehabilitation of spinal cord injury patients' upper limbs. For this purpose, a randomized controlled trial will be performed to compare the clinical and physiological effects of the brain-computer interface therapy with those of a sham intervention comprised by the application of functional electrical stimulation independently of brain-computer interface control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spinal Cord Injury
Keywords
brain-computer interface, functional electrical stimulation, motor rehabilitation, tetraplegia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Brain-Computer Interface controlled functional electrical stimulation feedback
Arm Type
Experimental
Arm Title
Sham Brain-Computer Interface controlled functional electrical stimulation feedback
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Brain-Computer Interface
Intervention Description
Hand movement will be elicited using functional electrical stimulation activated by the brain-computer interface based on hand movement intention.
Intervention Type
Device
Intervention Name(s)
Sham Brain-Computer Interface
Intervention Description
Hand movement will be elicited using functional electrical stimulation which activation will be independent of the brain-computer interface based on hand movement intention.
Primary Outcome Measure Information:
Title
Action Research Arm Test (ARAT)
Description
Change of upper limbs function. Scale ranges from 0 to 57 points for each upper limb. A higher score means a better upper limb function.
Time Frame
At enrollment and after 7 weeks of the intervention onset
Title
Upper Extremity Motor Score (UEMS)
Description
Change of upper limbs function. Scale ranges from 0 to 50 points if both upper limbs are assessed. A higher score means a better upper limb function.
Time Frame
At enrollment and after 7 weeks of the intervention onset
Title
Capabilities of Upper Extremities Questionnaire (CUE-Q)
Description
Change of the functional limitation in tetraplegia. Scale ranges from 32 to 224 points if both upper limbs are assessed. A higher score means less functional limitation outcome.
Time Frame
At enrollment and after 7 weeks of the intervention onset
Secondary Outcome Measure Information:
Title
Spinal Cord Independence Measure III (SCIM-III)
Description
Change of achievements of daily function. Scale ranges from 0 to 100 points. A higher score means a better capacity to perform activities of the daily living.
Time Frame
At enrollment and after 7 weeks of the intervention onset
Title
Life Satisfaction Questionnaire 9 (LISAT-9)
Description
Change of life satisfaction. Scale ranges from 0 to 54 points. A higher score is expected with a better life satisfaction.
Time Frame
At enrollment and after 7 weeks of the intervention onset
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Spinal Cord Injury at neurological levels C6 or C7
American Spinal Injury Association (ASIA) classification A, B, C or D
Upper limb spasticity of less or equal to +1 measured with the Modified Ashworth Scale
Time since disease onset of more than 6 months and less than 60 months
Normal or corrected to normal vision
Exclusion Criteria:
Severe attention deficits
Previous diagnosis of traumatic brain injury
Previous diagnosis of peripheral nerve injury
Previous stroke diagnosis
Previous diagnosis of neurodegenerative diseases
History of fractures in upper extremities
Skin lesions
Contractures in upper extremities that hamper mobility
Excessive muscle spasms
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Cantillo-Negrete, PhD
Phone
+525559991000
Ext
19008
Email
jcantillo@inr.gob.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Ruben I Carino-Escobar, PhD
Phone
+525559991000
Ext
19008
Email
ricarino@inr.gob.mx
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
19008
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
Efficacy of a Brain-Computer Interface Controlled Functional Electrical Stimulation Therapy for Spinal Cord Injury Neurorehabilitation
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