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Repetitive Transcranial Magnetic Stimulation for Enhancing Brain Computer Interphase-induced Plasticity in Stroke: a Crossover Design

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Max Planck Institute for Human Cognitive and Brain Sciences
RECRUITING
Leipzig
Contact Information
Primary
Aimee Arely Flores Sandoval, MsC
flores@cbs.mpg.de
+49 341 9940
Backup
Arno Villringer, MD PhD
villringer@cbs.mpg.de
+49 341 9940
Time Frame
Start Date: 2023-11-08
Estimated Completion Date: 2027-09-19
Participants
Target number of participants: 24
Treatments
Experimental: Active stimulation - Placebo stimulation
Participants will undergo a 2 intervention periods. The first intervention period will consist of a 2-week course of rTMS followed by BCI-mediated training. This intervention will be succeeded by a 4-week washout period to mitigate any carry-over effects. The second intervention period will entail 2 weeks of sham rTMS followed by BCI-mediated training.
Experimental: Placebo stimulation - Active stimulation
Participants will undergo the same interventions as the first arm but delivered in inverse order. The first intervention period will consist of 2 weeks of sham rTMS followed by BCI-mediated training. The second intervention period will entail 2 weeks of rTMS prior to BCI-mediated training and will start after a 4-weeks washout period.
Related Therapeutic Areas
Sponsors
Leads: Max Planck Institute for Human Cognitive and Brain Sciences
Collaborators: University of Halle Medical Faculty

This content was sourced from clinicaltrials.gov