Magnetic Brain Stimulation and Computer-based Motor Training for Rehabilitation After Stroke
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Chronic Stroke
In brief
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.
Key facts
- Study ID
- NCT06116942
- Run by
- Max Planck Institute for Human Cognitive and Brain Sciences
- People needed
- 24
- Starts
- 2023-11-08
- Expected to finish
- 2027-09-19
- Last updated by the study team
- 2023-11-09
Who can join
Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Max Planck Institute for Human Cognitive and Brain Sciences — Leipzig, Saxony, Germany (enrolling)
Full record on ClinicalTrials.gov
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