Clinical trial NCT03982329: Impact of nrTMS Therapy on the Progress of Neurorehabilitation
Official title: Evaluation of the Benefit of Navigated Repetitive Transcranial Magnetic Stimulation for Therapy of Surgery-related Motor Deficits in Brain Tumor Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transcranial Magnetic Stimulation, Repetitive
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2019-06-11
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2/3 nrTMS, 1/3 sham
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Fugl-Meyer Assessment (FMA)
timeFrame: Between first day of intervention and 3-months follow up
Secondary outcomes:
measure: Nine Hole Peg Test (NHPT)
timeFrame: First day of intervention = postoperatively, after the 7th day of intervention and after 3 months
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: First day of intervention = postoperatively, after the 7th day of intervention and after 3 months
measure: Jebsen Taylor Hand Function Test (JTHFT)
timeFrame: First day of intervention = postoperatively, after the 7th day of intervention and after 3 months
measure: Karnofsky Performance Status (KPS)
timeFrame: First day of intervention = postoperatively, after the 7th day of intervention and after 3 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Neurosurgery
state: Bavaria
Study officials:
affiliation: Department of Neurosurgery, School of Medicine, TU Munich
name: Sandro M. Krieg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.