Theta-Burst-Stimulation in Der frühen Rehabilitation Von Schlaganfallpatienten
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- University of Cologne
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Relative grip force
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Gereon R. Fink
Prof. Dr. med.
University of Cologne
Eligibility Criteria
Inclusion Criteria
- •written consent
- •age: 40-90 years
- •ischemic stroke
- •hemiparesis with impaired hand motor function
Exclusion Criteria
- •Subjects who are legally detained in an official institute (§20 MPG)
- •Participation in clinical trial within the last 12 weeks
- •Electronic implants or ferromagnetic Implants located in the head, neck or thorax (e.g. clips, intracranial shunt, artificial heart valve, pacemaker)
- •Medication pump (e.g. insulin pump)
- •Metal splinters in eye or head
- •Pregnancy / breastfeeding
- •Severe Neurodegenerative disease
- •Severe Neuroinflammatory disease
- •History of seizures / epilepsy
- •Physical addiction to alcohol, medication, or drugs (excluded: nicotine)
Outcomes
Primary Outcomes
Relative grip force
Time Frame: 3 months after enrollment
grip force as measured with vigorimeter
Secondary Outcomes
- Relative grip force(after 8 days of intervention, and 3 months after enrollment)
- Degree of disability(after 8 days of intervention, and 3 months after enrollment)
- Quality of life(after 8 days of intervention, and 3 months after enrollment)
- Stroke severity(after 8 days of intervention, and 3 months after enrollment)
- Days of rehabilitation after intervention phase(3 months after enrollment)
- Activities of daily living at admission and discharge in external rehabilitation facility(3 months after enrollment)
- Motor function(after 8 days of intervention, and 3 months after enrollment)
- Motorcortex excitability(after 8 days of intervention, and 3 months after enrollment)