Clinical trial NCT05343130: 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
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Spinal Cord Injury
Keywords: brain-computer interface
functional electrical stimulation
motor rehabilitation
tetraplegia
Lead sponsor: Instituto Nacional de Rehabilitacion
Sponsor class: OTHER_GOV
Collaborators: name: Instituto Tecnologico y de Estudios Superiores de Monterey
First posted: 2022-04-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: At enrollment and after 7 weeks of the intervention onset
measure: Upper Extremity Motor Score (UEMS)
timeFrame: At enrollment and after 7 weeks of the intervention onset
measure: Capabilities of Upper Extremities Questionnaire (CUE-Q)
timeFrame: At enrollment and after 7 weeks of the intervention onset
Secondary outcomes:
measure: Spinal Cord Independence Measure III (SCIM-III)
timeFrame: At enrollment and after 7 weeks of the intervention onset
measure: Life Satisfaction Questionnaire 9 (LISAT-9)
timeFrame: At enrollment and after 7 weeks of the intervention onset
Other outcomes:
Locations:
city: Tlalpan
country: Mexico
facility: Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation)
state: Mexico City
Study officials:
affiliation: Instituto Nacional de Rehabilitacion (National Institute of Rehabilitation)
name: Jessica Cantillo-Negrete, PhD
role: PRINCIPAL_INVESTIGATOR
References: