Theta-Burst-Stimulation in Early Rehabilitation of Stroke "TheSiReS"

Recruiting

Phase 2/3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Magstim Super Rapid2 System, intermittent theta-burst-stimulation (iTBS) protocol Device
    Intervention Desc: iTBS applied over ipsilesional M1
    ARM 1: Kind: Experimental
    Label: Real-rTMS
    Description: Repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex in the lesioned hemisphere using the intermittent theta-burst-stimulation protocol (iTBS; application of 3 pulses with a frequency of 50 Hz, in a theta-rhythm of 5 Hz for 2 seconds, repeated every 10 seconds, duration of one session: about 3,5 minutes) before physiotherapy for 8 days
  • Magstim Super Rapid2 System, sham-stimulation (in iTBS) Device
    Intervention Desc: iTBS applied with tilted coil over parieto-occipital vertex
    ARM 1: Kind: Experimental
    Label: Sham-rTMS
    Description: Repetitive transcranial magnetic stimulation (rTMS) in sham position (tilted coil over parieto-occipital vertex) before physiotherapy for 8 days

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Relative grip force 3 months after enrollment No
Secondary Motor function after 8 days of intervention, and 3 months after enrollment No
Secondary Stroke severity after 8 days of intervention, and 3 months after enrollment No
Secondary Degree of disability after 8 days of intervention, and 3 months after enrollment No
Secondary Motorcortex excitability after 8 days of intervention, and 3 months after enrollment No
Secondary Quality of life after 8 days of intervention, and 3 months after enrollment No
Secondary Activities of daily living at admission and discharge in external rehabilitation facility 3 months after enrollment No
Secondary Days of rehabilitation after intervention phase 3 months after enrollment No

Sponsors