Status:
RECRUITING
Magnetic Brain Stimulation and Computer-based Motor Training for Rehabilitation After Stroke
Lead Sponsor:
Max Planck Institute for Human Cognitive and Brain Sciences
Collaborating Sponsors:
University of Halle Medical Faculty
Conditions:
Chronic Stroke
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
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 approa...
Detailed Description
Aims of the study: 1. to provide preliminary evidence of the effect of rTMS (repetitive Transcranial Magnetic Stimulation) on brain-computer interface (BCI)-mediated plasticity on individuals with he...
Eligibility Criteria
Inclusion
- 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
- Present moderate to severe hemiparesis in an upper limb
- Language comprehension as well as visual and auditory perception sufficient to engage in Brain Computer Interface training
- Age from 20 to 80 years old
- Clear consciousness and stable vital signs
- Eligible for MRI, EEG, BCI and TMS methods
Exclusion
- 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)
- History of seizure
- Bone, joint and muscle diseases
- 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).
- 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
- Lesions in the upper extremities
- Bone, joint and muscle diseases
- Severe spasticity (higher than 3) or pain in the upper limb and affecting wrist extension
- Contraindications of undergoing TMS examinations: history of seizures, history of epilepsy, unclear unconsciousness, migraines or metals on the head
- Contraindications for MRI: metals in the body, metallic prosthetics or claustrophobia
- Participation in other interventional trials using BCI or rTMS within less than 6 months ago
- Participation in another interventional clinical trial
- Suspected lack of compliance
- Pregnant or nursing women
Key Trial Info
Start Date :
November 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 19 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06116942
Start Date
November 8 2023
End Date
September 19 2027
Last Update
November 9 2023
Active Locations (1)
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1
Max Planck Institute for Human Cognitive and Brain Sciences
Leipzig, Saxony, Germany, 04103