Magnetic brain stimulation and computer training for stroke rehabilitation
Repetitive Transcranial Magnetic Stimulation for Enhancing Brain Computer Interphase-induced Plasticity in Stroke: a Crossover Design
NA · Max Planck Institute for Human Cognitive and Brain Sciences · NCT06116942
This study is testing if combining magnetic brain stimulation with computer training can help people recover their movement skills after a stroke.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Max Planck Institute for Human Cognitive and Brain Sciences (other) |
| Locations | 1 site (Leipzig, Saxony) |
| Trial ID | NCT06116942 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to investigate the effectiveness of combining Transcranial Magnetic Stimulation (TMS) with a Brain-Computer Interface (BCI) to improve motor function in individuals who have experienced a stroke. Participants will undergo 25 sessions that include both active and sham TMS, followed by personalized BCI training based on their brain activity. The study will assess the impact of this innovative approach on brain plasticity and motor recovery, while also measuring adherence to the protocol for future research. Data will be collected through EEG and MRI assessments, along with various tests and questionnaires.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 80 who have experienced a subcortical stroke at least 6 months prior and have moderate to severe hemiparesis in an upper limb.
Not a fit: Patients with a history of seizures, significant psychiatric disorders, or those who are unable to engage in BCI training may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance motor recovery and quality of life for stroke survivors with limited hand movement.
How similar studies have performed: While the combination of TMS and BCI is a novel approach, similar studies have shown promise in enhancing rehabilitation outcomes for stroke patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Leipzig, Saxony
- Max Planck Institute for Human Cognitive and Brain Sciences — Leipzig, Saxony, Germany (RECRUITING)
Study contacts
- Principal investigator: Bernhard Sehm, PD. med. — Max Planck Institute for Human Cognitive and Brain Sciences and Halle University
- Study coordinator: Aimee Arely Flores Sandoval, MsC
- Email: flores@cbs.mpg.de
- Phone: +49 341 9940
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Stroke, Transcranial Magnetic Stimulation, Intermittent Theta Burst Stimulation, Brain-Computer Interface, Rehabilitation, EEG, MRI, Molecular changes