Theta-Burst-Stimulation in Recurrent Stroke Recovery

Not yet recruiting

Phase 2 Results N/A

Trial Description

The present study aims at investigating the effects of intermittent theta-burst stimulation (iTBS) for motor recovery in recurrent stroke patients. Therefore a daily intervention of repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy is compared to a control condition, sham stimulation combined with subsequent physiotherapy. Motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the first weeks and after three months.

Detailed Description

To date, the majority of neuromodulation approaches aiming at improving motor recovery after stroke are limited to patients with first-ever ischemic stroke. Therefore, rehabilitation of recurrent stroke mainly includes physiotherapy and occupational therapy. Yet, particular these patients retain movement impairment relevant for activities of daily living.
By using repetitive transcranial magnetic stimulation (rTMS), it is possible to promote recovery of connectivity between brain regions, particularly after stroke and thereby improve motor performance. Previous data indicate that intermittent theta-burst stimulation (iTBS), a protocol of neuromodulation, enhances the effects of subsequent motor training in early rehabilitation after stroke.
The current study aims at investigating whether daily repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy leads to better motor recovery in recurrent stroke, compared to control condition, physiotherapy after sham stimulation. Motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the first weeks and after three months.

Conditions

Interventions

  • Magstim Super Rapid2 System Device
    Intervention Desc: Sham stimulation
    ARM 1: Kind: Experimental
    Label: Real-iTBS
    ARM 2: Kind: Experimental
    Label: Sham-iTBS

Outcomes

Type Measure Time Frame Safety Issue
Primary Relative grip force 3 months after enrollment
Secondary Motor function After 8 days of intervention, and 3 months of enrollment
Secondary Stroke severity After 8 days of intervention, and 3 months of enrollment
Secondary Degree of disability After 8 days of intervention, and 3 months of enrollment
Secondary Motorcortex excitability/ Motor evoked potential After 8 days of intervention, and 3 months of enrollment
Secondary Motorcortex excitability/ Resting motor threshold After 8 days of intervention, and 3 months of enrollment
Secondary Motorcortex excitability/ Short-interval intracortical inhibition After 8 days of intervention, and 3 months of enrollment
Secondary Motorcortex excitability/ Ipsilateral silent period After 8 days of intervention, and 3 months of enrollment
Secondary Quality of life After 8 days of intervention, and 3 months of enrollment
Secondary Activities of daily living at admission and discharge in external rehabilitation facility After 8 days of intervention, and 3 months of enrollment
Secondary Days of rehabilitation after intervention phase 3 months after enrollment
Secondary Motor cortex excitability/ Motor evoked potential After 8 days of intervention, and 3 months of enrollment
Secondary Motor cortex excitability/ Resting motor threshold After 8 days of intervention, and 3 months of enrollment
Secondary Motor cortex excitability/ Short-interval intracortical inhibition After 8 days of intervention, and 3 months of enrollment
Secondary Motor cortex excitability/ Ipsilateral silent period After 8 days of intervention, and 3 months of enrollment

Sponsors