Impact of nrTMS Therapy on the Progress of Neurorehabilitation
NCT ID: NCT03982329
Last Updated: 2019-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
39 participants
INTERVENTIONAL
2015-06-30
2019-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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nrTMS group
15 minutes low-frequency nrTMS (1 Hz) of the uneffected hemisphere at 7 consecutive days
navigated repetitive transcranial magnetic stimulation
physical therapy
sham group
15 minutes sham stimulation of the uneffected hemisphere at 7 consecutive days
physical therapy
Interventions
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navigated repetitive transcranial magnetic stimulation
physical therapy
Eligibility Criteria
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Inclusion Criteria
* Written informed consent for participation
Exclusion Criteria
* Contraindications for nrTMS
* Only biopsy instead of tumor resection
* Patients without preserved MEP response as measured by postoperative nTMS motor mapping
18 Years
ALL
No
Sponsors
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Technical University of Munich
OTHER
Responsible Party
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Sandro M. Krieg
Attending Neurosurgeon
Principal Investigators
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Sandro M. Krieg, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Neurosurgery, School of Medicine, TU Munich
Locations
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Department of Neurosurgery
Munich, Bavaria, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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12/15S
Identifier Type: -
Identifier Source: org_study_id
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