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Low-frequency navigated repetitive transcranial magnetic stimulation (nrTMS) of the non-damaged hemisphere to increase cortical excitability of the damaged hemisphere and to reduce the increased neuronal inhibition in patients suffering from new surgery-related paresis after brain tumor resection
Postoperative loss of motor function greatly impairs the patients' quality of life and life expectancy of patients with brain tumors is significant limited. Hence the reduction of time spent on neurorehabilitation is very important.
Inclusion of patients that underwent brain tumor resection with a surgery-related paresis of the upper extremity.
Randomized controlled and double blinded trial - 2/3 nrTMS, 1/3 sham. Fifteen minutes low-frequency nrTMS (1 Hz) of the uneffected hemisphere at 7 consecutive days: nrTMS group or sham group. Thirty minutes physical therapy of the upper extremity in both groups.
MRI, nTMS motor mapping, assessments for motor status of upper extremity including Fugl-Meyer-Assessment (FMA), National Institution of Health Stroke Scale (NIHSS), Jebsen Taylor Hand Function Test (JTHFT), Nine Hole Peg Test (NHPT), and Karnofsky Performance Scale (KPS) postoperatively, after the 7th day of intervention and after 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nrTMS group | Active Comparator | 15 minutes low-frequency nrTMS (1 Hz) of the uneffected hemisphere at 7 consecutive days |
|
| sham group | Sham Comparator | 15 minutes sham stimulation of the uneffected hemisphere at 7 consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| navigated repetitive transcranial magnetic stimulation | Device |
| ||
| physical therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Fugl-Meyer Assessment (FMA) | Assessment upper extremity | Between first day of intervention and 3-months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Nine Hole Peg Test (NHPT) | Fine motor skills upper extremity | First day of intervention = postoperatively, after the 7th day of intervention and after 3 months |
| National Institutes of Health Stroke Scale (NIHSS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandro M. Krieg, MD | Contact | +498941402151 | sandro.krieg@tum.de | |
| Sebastian Ille, MD | Contact | +498941402151 | sebastian.ille@tum.de |
| Name | Affiliation | Role |
|---|---|---|
| Sandro M. Krieg, MD | Department of Neurosurgery, School of Medicine, TU Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery | Recruiting | Munich | Bavaria | 81675 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33984536 | Derived | Ille S, Kelm A, Schroeder A, Albers LE, Negwer C, Butenschoen VM, Sollmann N, Picht T, Vajkoczy P, Meyer B, Krieg SM. Navigated repetitive transcranial magnetic stimulation improves the outcome of postsurgical paresis in glioma patients - A randomized, double-blinded trial. Brain Stimul. 2021 Jul-Aug;14(4):780-787. doi: 10.1016/j.brs.2021.04.026. Epub 2021 May 11. |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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2/3 nrTMS, 1/3 sham
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| Procedure |
|
The scale measures neurological outcome; Total score is reported; Scores on the NIHSS range from 0 to 42, with higher scores indicating more severe disability
| First day of intervention = postoperatively, after the 7th day of intervention and after 3 months |
| Jebsen Taylor Hand Function Test (JTHFT) | Functionality upper extremity | First day of intervention = postoperatively, after the 7th day of intervention and after 3 months |
| Karnofsky Performance Status (KPS) | The scale measures general oncological outcome; the total score is reported; Scores on the KPS scale range from 0% to 100%, with higher scores indicating less disability and and better quality of life in cancer patients | First day of intervention = postoperatively, after the 7th day of intervention and after 3 months |