Transcranial Magnetic Stimulation, Repetitive
Conditions
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.
Interventions
PROCEDUREphysical therapy
Sponsors
Technical University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
2/3 nrTMS, 1/3 sham
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Fugl-Meyer Assessment (FMA) | Between first day of intervention and 3-months follow up | Assessment upper extremity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nine Hole Peg Test (NHPT) | First day of intervention = postoperatively, after the 7th day of intervention and after 3 months | Fine motor skills upper extremity |
| National Institutes of Health Stroke Scale (NIHSS) | First day of intervention = postoperatively, after the 7th day of intervention and after 3 months | 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 |
| Jebsen Taylor Hand Function Test (JTHFT) | First day of intervention = postoperatively, after the 7th day of intervention and after 3 months | Functionality upper extremity |
| Karnofsky Performance Status (KPS) | First day of intervention = postoperatively, after the 7th day of intervention and after 3 months | 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 |
Countries
Germany
Contacts
Primary ContactSandro M. Krieg, MD
Backup ContactSebastian Ille, MD
Outcome results
None listed