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NCT Number: NCT05343130

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

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.

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Key information

Conditions

Cervical Spinal Cord Injury Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Quadriplegia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Tlalpan, Mexico City, 14389, Mexico

Location status: Recruiting

Location contact

Jessica Cantillo-Negrete, PhD

CONTACT

[email protected]

+52 55 59991000 ext. 19008

Jessica Cantillo-Negrete, PhD

PRINCIPAL_INVESTIGATOR

Ruben I. Carino-Escobar, PhD

CONTACT

[email protected]

+52 55 59991000 ext. 19008

Ruben I. Carino-Escobar, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brain-Computer Interface

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

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.

Primary outcomes

  1. Action Research Arm Test (ARAT)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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 outcomes

  1. Spinal Cord Independence Measure III (SCIM-III)

    Time frame: 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)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Cantillo-Negrete, PhD

CONTACT

[email protected]

+525559991000 ext. 19008

Ruben I Carino-Escobar, PhD

CONTACT

[email protected]

+525559991000 ext. 19008

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Rehabilitacion

Other Gov

Collaborators

  • Instituto Tecnologico y de Estudios Superiores de Monterey

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 25, 2022
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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