Theta-Burst-Stimulation in Recurrent Stroke Recovery
|ClinicalTrials.gov Identifier: NCT03337867|
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : January 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stroke Neurorehabilitation||Device: Magstim Super Rapid2 System||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Theta-Burst-Stimulation in Recurrent Stroke Recovery|
|Actual Study Start Date :||January 11, 2018|
|Estimated Primary Completion Date :||November 1, 2019|
|Estimated Study Completion Date :||February 1, 2020|
|Active Comparator: Real-iTBS||
Device: Magstim Super Rapid2 System
Intermittent theta-burst-stimulation (iTBS) protocol
|Sham Comparator: Sham-iTBS||
Device: Magstim Super Rapid2 System
- Relative grip force [ Time Frame: 3 months after enrollment ]grip force as measured with vigorimeter
- Relative grip force [ Time Frame: After 8 days of intervention, and 3 months of enrollment ]Grip force as measured with vigorimeter
- Motor function [ Time Frame: After 8 days of intervention, and 3 months of enrollment ]Action Research Arm Test, ARAT
- Motor function [ Time Frame: 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 summed
- Stroke severity [ Time Frame: 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.
- Degree of disability [ Time Frame: 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/ Motor evoked potential [ Time Frame: After 8 days of intervention, and 3 months of enrollment ]Motor evoked potential (MEP) induced by stimulation of the affected motor cortex
- Motor cortex excitability/ Resting motor threshold [ Time Frame: After 8 days of intervention, and 3 months of enrollment ]Resting motor threshold as measured by stimulation of the affected motor cortex, RMT
- Motor cortex excitability/ Short-interval intracortical inhibition [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: After 8 days of intervention, and 3 months of enrollment ]EuroQol 5D questionnaire, EQ-5D
- Activities of daily living at admission and discharge in external rehabilitation facility [ Time Frame: 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.
- Days of rehabilitation after intervention phase [ Time Frame: 3 months after enrollment ]Days of rehabilitation after intervention phase as documented by external rehabilitation facility
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03337867
|Contact: Caroline Tscherpelfirstname.lastname@example.org|
|Contact: Caroline Tscherpel||+49 221 478 email@example.com|
|Cologne, Germany, 50937|
|Contact: Christian Grefkes, MD +49 221 478 82872 firstname.lastname@example.org|
|Contact: Caroline Tscherpel +49 221 478 82872 email@example.com|
|Principal Investigator: Christian Grefkes|
|Sub-Investigator: Caroline Tscherpel|
|Principal Investigator:||Christian Grefkes, MD||University Hospital Cologne|