Impact of nrTMS Therapy on the Progress of Neurorehabilitation

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Evaluation of the Benefit of Navigated Repetitive Transcranial Magnetic Stimulation for Therapy of Surgery-related Motor Deficits in Brain Tumor Patients

Conditions
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Transcranial Magnetic Stimulation, Repetitive

Intervention / Treatment
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* Device: navigated repetitive transcranial magnetic stimulation
* Procedure: physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New surgery-related paresis of upper extremity after brain tumor resection Written informed consent for participation Exclusion Criteria: Contraindications for MRI Contraindications for nrTMS Only biopsy instead of tumor resection Patients without preserved MEP response as measured by postoperative nTMS motor mapping

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2/3 nrTMS, 1/3 sham
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nrTMS group<br>15 minutes low-frequency nrTMS (1 Hz) of the uneffected hemisphere at 7 consecutive days | Device: navigated repetitive transcranial magnetic stimulation<br> <br> Procedure: physical therapy<br> <br> |
| Sham Comparator: sham group<br>15 minutes sham stimulation of the uneffected hemisphere at 7 consecutive days | Procedure: physical therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Fugl-Meyer Assessment (FMA) | Assessment upper extremity | Between first day of intervention and 3-months follow up | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |