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

ConditionCervical Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto Nacional de Rehabilitacion

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Severe attention deficits

Previous diagnosis of traumatic brain injury

Previous diagnosis of peripheral nerve injury

Previous stroke diagnosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Brain-Computer Interface controlled functional electrical stimulation feedbackExperimental treatment 1 intervention
Group B: Sham Brain-Computer Interface controlled functional electrical stimulation feedbackSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At enrollment and after 7 weeks of the intervention onset
2

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.

Time frame
At enrollment and after 7 weeks of the intervention onset
3

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.

Time frame
At enrollment and after 7 weeks of the intervention onset

Secondary outcomes

1

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.

Time frame
At enrollment and after 7 weeks of the intervention onset
2

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.

Time frame
At enrollment and after 7 weeks of the intervention onset

Other outcomes

Sponsors and contacts

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Instituto Nacional de Rehabilitacion

Lead sponsor

Instituto Tecnologico y de Estudios Superiores de Monterey

Collaborator

Source ClinicalTrials.gov
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