Validation of a Brain-Computer Interface for Stroke Neurological Upper Limb Rehabilitation

Instituto Nacional de Rehabilitacion

Status: Completed

Conditions: Stroke; Stroke, Ischemic

Treatments: Device: Brain-Computer Interface; Device: Sham Brain-Computer Interface

Study type: Interventional

Funder types: Other

Identifiers

NCT04724824

SALUD-2018-02-B-S-45803

Details and patient eligibility

About

The study's main goal is to determine if clinical and physiological effects of a brain-computer interface intervention for the neurorehabilitation of stroke patients' upper limb are greater than the effects of a sham robotic feedback. For this purpose a randomized controlled trial will be performed to compare somatosensory sham robotic feedback with the same somatosensory feedback controlled with the brain-computer interface output.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of first ischemic stroke
• Time since stroke onset higher than 3 months and lower than 24 months
• Hand paresis
• Normal or corrected to normal vision
• Without previous diagnosed neurological diseases

Exclusion criteria

• Clinical diagnosis of severe aphasia
• Clinical diagnosis of severe depression
• Clinical diagnosis of severe attention deficits
• Previous diagnosis of traumatic brain injury
• Previous diagnosis of spinal cord injury
• Previous diagnosis of peripheral nerve injury

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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23 participants in 2 patient groups

Brain-Computer Interface controlled robotic feedback

Experimental group

Treatment:

Device: Brain-Computer Interface

Sham Brain-Computer Interface controlled robotic feedback

Sham Comparator group

Treatment:

Device: Sham Brain-Computer Interface