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

• Sponsor: Instituto Nacional de Rehabilitacion (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05343130
• Collaborator: Instituto Tecnologico y de Estudios Superiores de Monterey (Other)
• Enrollment: 32
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 28
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Spinal Cord Injury	Device: Brain-Computer Interface; Device: Sham Brain-Computer Interface	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Brain-Computer Interface controlled functional electrical stimulation feedback	Device: Brain-Computer Interface; Hand movement will be elicited using functional electrical stimulation activated by the brain-computer interface based on hand movement intention.
Sham Comparator: Sham Brain-Computer Interface controlled functional electrical stimulation feedback	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.

Outcome Measures

Primary Outcome Measures

1. Action Research Arm Test (ARAT) [At enrollment and after 7 weeks of the intervention onset]

   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.

2. Upper Extremity Motor Score (UEMS) [At enrollment and after 7 weeks of the intervention onset]

   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.

3. Capabilities of Upper Extremities Questionnaire (CUE-Q) [At enrollment and after 7 weeks of the intervention onset]

   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

1. Spinal Cord Independence Measure III (SCIM-III) [At enrollment and after 7 weeks of the intervention onset]

   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.

2. Life Satisfaction Questionnaire 9 (LISAT-9) [At enrollment and after 7 weeks of the intervention onset]

   Change of life satisfaction. Scale ranges from 0 to 54 points. A higher score is expected with a better life satisfaction.

Eligibility Criteria

Criteria

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

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

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
• Instituto Tecnologico y de Estudios Superiores de Monterey

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: NCT05343130
• Other Study ID Numbers: 10/22
• First Posted: Apr 25, 2022
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 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; functional electrical stimulation; motor rehabilitation; tetraplegia
• Additional relevant MeSH terms: Spinal Cord Injuries; Wounds and Injuries

Study Results

No Results Posted as of Aug 3, 2022