Theta-Burst-Stimulation in Recurrent Stroke Recovery
- Conditions
- NeurorehabilitationStroke
- Interventions
- Device: Magstim Super Rapid2 System
- Registration Number
- NCT03337867
- Lead Sponsor
- University Hospital of Cologne
- Brief Summary
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- written consent
- age: 40-90 years
- recurrent stroke
- hemiparesis with impaired hand motor function
- Subjects who are legally detained in an official institute (§20 MPG)
- 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)
- Insufficient compliance
- Present or past malignant tumor involving the central nervous system
- Severe Psychiatric disease
- Frequent medication with benzodiazepines, high-potency antipsychotics or tricyclic antidepressants before hospitalization or long-term during hospitalization
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Real-iTBS Magstim Super Rapid2 System - Sham-iTBS Magstim Super Rapid2 System -
- Primary Outcome Measures
Name Time Method Relative grip force 3 months after enrollment grip force as measured with vigorimeter
- Secondary Outcome Measures
Name Time Method Stroke severity After 8 days of intervention, and 3 months of enrollment National Instituts of Health Stroke Scale, NIHSS The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.
The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.Motor cortex excitability/ Motor evoked potential After 8 days of intervention, and 3 months of enrollment Motor evoked potential (MEP) induced by stimulation of the affected motor cortex
Degree of disability After 8 days of intervention, and 3 months of enrollment Modified Rankin Scale, mRS The scale runs from 0-6, running from perfect health (0) without symptoms to death (6).
Motor cortex excitability/ Resting motor threshold After 8 days of intervention, and 3 months of enrollment Resting motor threshold as measured by stimulation of the affected motor cortex, RMT
Activities of daily living at admission and discharge in external rehabilitation facility After 8 days of intervention, and 3 months of enrollment Barthel-Index (BI) scores as documented by external rehabilitation facility The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL). A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. The scale yield a score of 0-100.
Relative grip force After 8 days of intervention, and 3 months of enrollment Grip force as measured with vigorimeter
Motor cortex excitability/ Short-interval intracortical inhibition After 8 days of intervention, and 3 months of enrollment Short-interval intracortical inhibition Short-interval intracortical inhibition (SICI) is a widely used paired-pulse transcranial magnetic stimulation (TMS) measure to assess inhibition in human motor cortex
Motor cortex excitability/ Ipsilateral silent period After 8 days of intervention, and 3 months of enrollment Ipsilateral silent period The ipsilateral silent period (iSP) is supposed to be a specific marker of transcallosal motor inhibition. Measured by a short attenuation or interruption of ongoing voluntary electromyographic (EMG) activity in hand muscles induced by focal TMS of the ipsilateral M1.
Quality of life After 8 days of intervention, and 3 months of enrollment EuroQol 5D questionnaire, EQ-5D
Motor function After 8 days of intervention, and 3 months of enrollment Fugl-Meyer Motor Scale of the upper extremity, FM The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully.
Minimum score in upper limb = 0 Maximum score in upper limb = 66, Subscales are summedDays of rehabilitation after intervention phase 3 months after enrollment Days of rehabilitation after intervention phase as documented by external rehabilitation facility
Trial Locations
- Locations (1)
Christian Grefkles
🇩🇪Cologne, Germany