Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Swiss National Science Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Background: Stroke is a leading cause of adult disability. Non-invasive brain stimulation can induce significant and sustained improvements in functional outcome. However the effect is inconsistent and difficult to predict, in particular in the subacute phase after stroke. Although several different stimulation techniques are available, it is unknown which is suitable for which patient.
Objectives: This study has three main objectives:
Method: 45 patients with ischemic or hemorrhagic stroke will be randomly assigned to one of 3 groups: cTBS, tDCS, or sham stimulation. Each group will receive the corresponding stimulation therapy 3 times per week for 3 weeks, immediately before intensive physical therapy. Before and after the treatment period, standardized assessments of sensorimotor function areas are obtained together with electroencephalography and functional magnetic resonance recordings. These recordings will be used to analyze and compare the neural effects of each treatment modality.
Clinical Implication: The results of this study might help optimize and individualize stimulation treatment for patients with subacute stroke. It may hence facilitate the transfer of brain stimulation therapy to routine clinical practice.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cTBS | Active Comparator | A transcranial magnetic stimulator (MagPro X100, Medtronic Functional Diagnostics, Skovlunde, Denmark) will deliver continuous bursts of bipolar magnetic pulses exerting an inhibition on the underlying brain tissue (cTBS). The stimulation coil will be placed over the unaffected primary motor cortex. The stimulation protocol implies 200 bursts, each consisting of three pulses applied at 30 Hz, repeated at inter-burst intervals of 167 ms. Two stimulation trains of 30 s, separated by 15 min, will be applied 3 times per week for 3 weeks and will be immediately followed by physical therapy. |
|
| cathodal tDCS | Active Comparator | A stimulator (NeuroConn GmbH, Illmenau, Germany) will deliver cathodal transcranial direct current stimulation (tDCS) of the unaffected motor cortex. The anode will be placed over the contralateral supraorbital region. Stimulation will be performed for 25 min, 3 times per week for 3 weeks during upper extremity treatment sessions. |
|
| sham stimulation | Sham Comparator | This group will receive the same stimulation protocol as used for the active groups except that sham stimuli will be applied. Half of the patients receive sham cTBS, the other half sham tDCS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cTBS | Device |
|
| |
| cathodal tDCS |
| Measure | Description | Time Frame |
|---|---|---|
| Change in compound motor score slope at week 4 | The Fugl Meyer motor assessment (FMA), the Nine Hole Peg test (expressed as pegs per minute), and the Jamar dynamometer strength of the affected arm are normalized to the healthy arm and averaged to a compound motor score. This score is obtained twice before treatment (at weeks -1 and 0 relative to treatment start), and twice after treatment (at weeks 4 and 8). Primary outcome measure is the change in slope from week 0 to 4 as compared to the slope between week -1 and 0. | week 4 after treatment start |
| Change in alpha-band coherence between the affected motor cortex and the rest of the brain | Calculated from electroencephalography recordings | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fugl Meyer Upper Extremity Motor Score at week 4 | Week 4 | |
| Change in Fugl Meyer Upper Extremity Motor Score at week 8 | Week 8 | |
| Change in alpha-band coherence between the unaffected motor cortex and the rest of the brain |
| Measure | Description | Time Frame |
|---|---|---|
| Total Fugl Meyer motor assessment score at week 4 | Week 4 | |
| Total Fugl Meyer motor assessment score at week 8 | Week 8 | |
| Change in average velocity in the Nine Hole Peg test at week 4 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adrian G Guggisberg, MD | University Hospital, Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Neurorééducation, Unversity Hospital | Geneva | 1211 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23941616 | Background | Rizk S, Ptak R, Nyffeler T, Schnider A, Guggisberg AG. Network mechanisms of responsiveness to continuous theta-burst stimulation. Eur J Neurosci. 2013 Oct;38(8):3230-8. doi: 10.1111/ejn.12334. Epub 2013 Aug 14. | |
| 29223708 | Derived | Nicolo P, Magnin C, Pedrazzini E, Plomp G, Mottaz A, Schnider A, Guggisberg AG. Comparison of Neuroplastic Responses to Cathodal Transcranial Direct Current Stimulation and Continuous Theta Burst Stimulation in Subacute Stroke. Arch Phys Med Rehabil. 2018 May;99(5):862-872.e1. doi: 10.1016/j.apmr.2017.10.026. Epub 2017 Dec 7. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 2, 2018 | |
| Reset | Dec 3, 2018 | |
| Release | May 7, 2019 | |
| Reset | Jul 17, 2019 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 2, 2018 | Dec 3, 2018 | |||
| May 7, 2019 |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
|
|
| sham stimulation | Device |
|
| Week 4 |
| Change in activity of daily life scale (motor activity log, MAL) | Week 4 |
| Change in activity of daily life scale (motor activity log, MAL) | Week 8 |
| Number of adverse events | Week 4 |
| Number of adverse events | Week 8 |
expressed in pegs/sec |
| Week 4 |
| Change in average velocity in the Nine Hole Peg test at week 8 | expressed in pegs/sec | Week 8 |
| Change in Jamar Dynamometer strength at week 4 | Week 4 |
| Change in Jamar Dynamometer strength at week 8 | Week 8 |
| Change in Score of the Box and Block test, week 4 | Week 4 |
| Change in Score of the Box and Block test, week 8 | week 8 |
| Correlation between change in alpha band coherence and clinical improvements | Alpha band coherence is calculated from electroencephalography (EEG) recordings | Week 4 |
| Change in fractional anisotropy of the affected cortico-spinal tract | Calculated from diffusion tensor imaging (DTI) sequences of magnetic | Week 4 |
| Change in correlations of spontaneous fMRI fluctuations within the motor network | Calculated from functional magnetic resonance (fMRI) recordings | Week 4 |
| Jul 17, 2019 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |