Magnetic brain stimulation and computer training for stroke rehabilitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.