Clinical trial NCT04724824: Validation of a Brain-Computer Interface for Stroke Neurological Upper Limb Rehabilitation
Official title: Validation of a Brain-Computer Interface for Neurorehabilitation With a Randomized Controlled Trial (Validación de Una Interfaz Cerebro-Computadora Para Rehabilitación Neurológica Por Medio de un Ensayo Clínico Controlado y Aleatorizado)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Stroke
Keywords: brain-computer interface
robotic orthosis
hemiparesis
motor rehabilitation
Lead sponsor: Instituto Nacional de Rehabilitacion
Sponsor class: OTHER_GOV
Collaborators: name: National Council of Science and Technology, Mexico
name: Hospital General Dr. Manuel Gea González
name: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
First posted: 2021-01-26
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean change from baseline in upper limb motor function on the Fugl-Meyer Assessment for the Upper Extremity
timeFrame: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
measure: Mean change from baseline in upper limb motor function on the Action Research Arm Test
timeFrame: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Secondary outcomes:
measure: Mean change from baseline in cortical activity measured with Functional Magnetic Resonance Imaging
timeFrame: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
measure: Mean change from baseline in corticospinal excitability measured with Transcranial Magnetic Stimulation
timeFrame: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
measure: Mean change from baseline in grip strength measured with a dynamometer
timeFrame: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Other outcomes:
Locations:
city: Tlalpan
country: Mexico
facility: Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation)
state: Mexico City
Study officials:
affiliation: Instituto Nacional de Rehabilitacion (National Institute of Rehabilitation)
name: Jessica Cantillo-Negrete, PhD
role: PRINCIPAL_INVESTIGATOR
References: