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

Recruiting
18 years of age
Both
Phase N/A

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Overview

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

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

Study details

Cervical Spinal Cord Injury

NCT05343130

Instituto Nacional de Rehabilitacion

27 January 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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