💬In plain words
What the trial is, and whether it could suit you
The goal of the present clinical trial is to explore whether an innovative technology-based approach can help individuals who have had a stroke and can no longer move their hands with ease. Our approach consists of a combination of two technologies: Transcranial Magnetic Stimulation (TMS) and a Brain-Computer Interface (BCI). The former entails the application of magnetic fields over the head to stimulate the brain preparing it for a better ability to produce movement. The latter consists of measuring brain activity to personalize a type of computer-based training that is designed to increase communication between the brain and the muscles.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Diagnosis of a subcortical stroke at least 6 months before the initiation of the trial and confirmed with magnetic resonance imaging (MRI) or computed tomography
2. Present moderate to severe hemiparesis in an upper limb
3. Language comprehension as well as visual and auditory perception sufficient to engage in Brain Computer Interface training
4. Age from 20 to 80 years old
5. Clear consciousness and stable vital signs
6. Eligible for MRI, EEG, BCI and TMS methods
Exclusion Criteria:
1. Drug abuse or recent changes in medications that may alter the central nervous system when the measurements begin or during the measurements (e.g., benzodiazepines, serotoninergic and dopaminergic agents)
2. History of seizure
3. Bone, joint and muscle diseases
4. Peripheral neuropathy or other neurological or psychiatric diseases (including, tinnitus, migraine, or mood disorders with the exception of minimal, mild, and moderate depression, reflected as a Beck depression scale score lower than 29).
5. Strong cognitive deficits (including speech, attention, hearing, vision, sensation or intelligence deficits) reflected as a Montreal Cognitive Assessment (MoCA) score lower or equal to 24
6. Lesions in the upper extremities
7. Bone, joint and muscle diseases
8. Severe spasticity (higher than 3) or pain in the upper limb and affecting wrist extension
9. Contraindications of undergoing TMS examinations: history of seizures, history of epilepsy, unclear unconsciousness, migraines or metals on the head
10. Contraindications for MRI: metals in the body, metallic prosthetics or claustrophobia
11. Participation in other interventional trials using BCI or rTMS within less than 6 months ago
12. Participation in another interventional clinical trial
13. Suspected lack of compliance
14. Pregnant or nursing women
HealthTeky