NCT05005780

Stroke Therapy With Brain Oscillation Synchronized Stimulation

Stroke Therapy With Brain Oscillation Synchronized Stimulation: Randomized Controlled Pilot Study to Compare the Therapeutic Effectiveness of a Personalized EEG-triggered Repetitive High-frequency TMS Therapy Protocol With Standard Low-frequency TMS Therapy Protocol in Patients With Spastic Paresis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This randomized, controlled, double-blind clinical pilot trial investigates the therapeutic potential of a novel personalized therapeutic brain-stimulation protocol in chronic stroke patients with spasticity. Stroke patients will either receive ipsilesional 100 Hz transcranial magnetic stimulation (TMS) triplet burst protocol synchronized to the ongoing µ-alpha oscillation or contralesional 1 Hz repetitive TMS (rTMS) protocol. Motor recovery is assessed directly after as well as three months after completion of the therapy.

Detailed description

Stroke is one of the leading cause for long-term disability worldwide. The standard approach to treat deficits after stroke is a rehabilitation therapy, that follows the stroke event directly. This therapy mainly includes physiotherapy and occupational therapy. Yet, despite intensive rehabilitation efforts, more than half of all stroke patients remain greatly disabled. Repetitive TMS is capable of inducing plasticity-like effects in the brain, that are expected to enhance adaptive plasticity processes leading to functional regain after stroke. In the motor cortex, brain oscillation-synchronized TMS, i.e. TMS triggered dependent on the phase of instantaneous µ-alpha oscillations as detected by real-time EEG (electroencephalography) analysis, has been shown to consistently increase motor cortical excitability and plasticity effects. We therefore hypothesis that a greater therapeutic potential of TMS to modulate dysfunctional brain networks can be exploited by personalizing TMS therapy to individual brain states (i.e. brain oscillations). This study aims to investigate the effectiveness of an ipsilesional 100 Hz TMS triplet burst protocol synchronized to the ongoing µ-alpha oscillation compared to the current TMS standard therapy of contralesional 1 Hz rTMS in chronic stroke patients. Both groups will undergo stimulation therapy three times a week, with each session directly followed by physiotherapy. Motor recovery will be assessed directly after as well as three months after completion of the therapy.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Negative peak triggered 100 Hz triplet burst TMS	MagVenture MagPro X100: Ipsilesional negative peak triggered 100 Hz triplet burst TMS.
DEVICE	1 Hz rTMS	MagVenture MagPro X100: Contralesional 1 Hz rTMS.

Timeline

• Start date: 2019-10-02
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2021-08-16
• Last updated: 2023-08-18

Locations

1 site across 1 country: Germany