NCT02910024

Theta-Burst-Stimulation in Early Rehabilitation of Stroke

Theta-Burst-Stimulation in Der frühen Rehabilitation Von Schlaganfallpatienten

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The present prospective, randomized, controlled, double-blinded trial investigates the effects of intermittent theta-burst stimulation (iTBS) during the early rehabilitation after stroke. Patients with hemipresis will receive either sham or real iTBS over their affected hemispheres before occupational therapy for 8 days. Motor recovery is assessed one day after the intervention phase and three months after enrollment.

Detailed description

To date, rehabilitation of stroke with hemiparesis mainly includes physiotherapy and occupational therapy. Yet, the majority of patients retain movement impairment relevant for activities of daily living. One explanation for this deficit is the insufficient recovery of connectivity between brain regions after stroke. It is possible to modulate this process by repetitive transcranial magnetic stimulation (rTMS) using the protocol of intermittent theta-burst stimulation (iTBS). Previous data indicate that modulation of the motor cortex with iTBS enhances the effects of subsequent motor training. The present study aims at investigating whether daily repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy leads to better motor recovery, compared with physiotherapy after sham stimulation. In the first weeks and after three months, motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of stroke patients. Amendment (approved by the Ethics-Committee of the Medical Faculty of the University of Cologne, 20/12/2016): Specification of exclusion criteria. Amendment (approved by the Ethics-Committee of the Medical Faculty of the University of Cologne, 15/11/2018): Change of inclusion and exclusion criteria.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Magstim Super Rapid2 System, intermittent theta-burst-stimulation (iTBS) protocol	iTBS applied over ipsilesional M1
DEVICE	Magstim Super Rapid2 System, sham-stimulation (in iTBS)	iTBS applied with tilted coil over parieto-occipital vertex

Timeline

• Start date: 2016-04-01
• Primary completion: 2022-09-15
• Completion: 2022-09-15
• First posted: 2016-09-21
• Last updated: 2022-09-21

Locations

1 site across 1 country: Germany