NCT06116942Recruiting
Magnetic Brain Stimulation and Computer-based Motor Training for Rehabilitation After Stroke
Repetitive Transcranial Magnetic Stimulation for Enhancing Brain Computer Interphase-induced Plasticity in Stroke: a Crossover Design
Source: ClinicalTrials.gov · Last updated 9 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 27 Sept 2023
- Start date
- 8 Nov 2023
- Primary completion date
- 19 Sept 2026
- Lead sponsor
- Max Planck Institute for Human Cognitive and Brain Sciences
- Diseases
- Stroke
- NCT number
- NCT06116942
What you commit to
- Study type: Interventional
- Planned participants: 24
- From 8 Nov 2023 to the primary completion date, 19 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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).
- Bone, joint and muscle diseases
- Contraindications of undergoing TMS examinations: history of seizures, history of epilepsy, unclear unconsciousness, migraines or metals on the head
Other
- 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
- Severe spasticity (higher than 3) or pain in the upper limb and affecting wrist extension
- 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
Who the study is looking for
- 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
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Max Planck Institute for Human Cognitive and Brain Sciences Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.