Efficacy of a Brain-Computer Interface Controlled Functional Electrical Stimulation Therapy for Spinal Cord Injury Neurorehabilitation

NCT ID: NCT05343130

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Brain-Computer Interface controlled functional electrical stimulation feedback

Group Type EXPERIMENTAL

Brain-Computer Interface

Intervention Type DEVICE

Hand movement will be elicited using functional electrical stimulation activated by the brain-computer interface based on hand movement intention.

Sham Brain-Computer Interface controlled functional electrical stimulation feedback

Group Type SHAM_COMPARATOR

Sham Brain-Computer Interface

Intervention Type DEVICE

Hand movement will be elicited using functional electrical stimulation which activation will be independent of the brain-computer interface based on hand movement intention.

Interventions

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Brain-Computer Interface

Hand movement will be elicited using functional electrical stimulation activated by the brain-computer interface based on hand movement intention.

Intervention Type DEVICE

Sham Brain-Computer Interface

Hand movement will be elicited using functional electrical stimulation which activation will be independent of the brain-computer interface based on hand movement intention.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Tecnologico y de Estudios Superiores de Monterey

OTHER

Sponsor Role collaborator

Instituto Nacional de Rehabilitacion

OTHER_GOV

Sponsor Role lead

Responsible Party

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Jessica Cantillo-Negrete

Researcher in Medical Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessica Cantillo-Negrete, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Rehabilitacion (National Institute of Rehabilitation)

Locations

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Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation)

Tlalpan, Mexico City, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Jessica Cantillo-Negrete, PhD

Role: CONTACT

+525559991000 ext. 19008

Ruben I Carino-Escobar, PhD

Role: CONTACT

+525559991000 ext. 19008

Facility Contacts

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Jessica Cantillo-Negrete, PhD

Role: primary

+52 55 59991000 ext. 19008

Ruben I. Carino-Escobar, PhD

Role: backup

+52 55 59991000 ext. 19008

Other Identifiers

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10/22

Identifier Type: -

Identifier Source: org_study_id

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