Stroke, Ischemic, Stroke
Conditions
Keywords
brain-computer interface, robotic orthosis, hemiparesis, motor rehabilitation
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.
Interventions
DEVICEBrain-Computer Interface
Passive hand movement will be provided to patients' paralyzed hand by means of a robotic hand orthosis that will be activated by the brain-computer interface based on hand movement intention.
Passive hand movement will be provided to patients' paralyzed hand by means of a robotic hand orthosis which activation will be independent of the output of the brain-computer interface based on hand movement intention.
Sponsors
National Council of Science and Technology, Mexico
Hospital General Dr. Manuel Gea González
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Instituto Nacional de Rehabilitacion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in upper limb motor function on the Fugl-Meyer Assessment for the Upper Extremity | At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset | Analysis of changes on the Fugl-Meyer Assessment for the Upper Extremity will reveal if there is a clinical significant sensorimotor function compared to baseline |
| Mean change from baseline in upper limb motor function on the Action Research Arm Test | At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset | Analysis of changes on the Action Research Arm Test will reveal if there is a clinical significant motor function compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in cortical activity measured with Functional Magnetic Resonance Imaging | At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset | Blood-oxygen-level-dependent imaging will be analyzed to assess if there are changes in cortical activity compared to baseline. |
| Mean change from baseline in corticospinal excitability measured with Transcranial Magnetic Stimulation | At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset | Motor Evoked Potentials parameters will reveal if there are changes of corticospinal excitability in both hemibodies compared to baseline |
| Mean change from baseline in grip strength measured with a dynamometer | At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset | Analysis of hand strength measurements will reveal if there were changes compared to baseline |
Countries
Mexico
Outcome results
None listed