Magnetic Brain Stimulation and Computer-based Motor Training for Rehabilitation After Stroke

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.

Conditions

• Chronic Stroke

Interventions

DEVICE

Active rTMS

The Transcranial Magnetic Stimulation will consist of placing a figure-of-eight shape coil of wire over the head of the participants. Then, a brief electric current will pass through the coil, inducing a magnetic field capable of stimulating neurons located beneath the coil. For the active coil, the maximal stimulation intensity is reached beneath the center of the coil. In the present study, the intermittent theta-burst protocol will be implemented. This protocol is expected to modulate the excitability of the brain, priming it for a stronger activation of the motor-related brain areas engaged during brain-computer interface-based training. The structural MRI of each participant will be used to guide neuronavigation towards ipsilesional motor areas.

DEVICE

Sham rTMS

To implement a placebo stimulation, a sham coil will be used to deliver the same stimulation protocol. The sham coil is identical in dimensions and weight to the active coil but produces a diminished magnetic field. For the sham coil, the stimulation intensity is minimal beneath the center of the coil, the same area with the highest intensity during stimulation with an active coil. The structural MRI scan of each participant will be used to guide neuronavigation towards the same area where the active stimulation was applied.

Sponsors & Collaborators

• University of Halle Medical Faculty

  collaborator OTHER

• Max Planck Institute for Human Cognitive and Brain Sciences

  lead OTHER

Principal Investigators

• Aimee Flores-Sandoval, MsC · Charité Universitätmedizin Berlin and Max Planck Institute for Human Cognitive and Brain Sciences

• Arno Villringer, MD PhD · Max Planck Institute for Human Cognitive and Brain Sciences

• Bernhard Sehm, PD. med. · Max Planck Institute for Human Cognitive and Brain Sciences and Halle University

• Vadim Nikulin, PhD. · Max Planck Institute for Human Cognitive and Brain Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

20 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-08

Primary Completion

2026-09-19

Completion

2027-09-19

Countries

• Germany

Study Locations