Impact of nrTMS Therapy on the Progress of Neurorehabilitation

Technical University of Munich

Status: Unknown

Conditions: Transcranial Magnetic Stimulation, Repetitive

Treatments: Procedure: physical therapy; Device: navigated repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03982329

12/15S

Details and patient eligibility

About

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

Full 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.

Enrollment: 39 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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39 participants in 2 patient groups

nrTMS group

Active Comparator group

Description:

15 minutes low-frequency nrTMS (1 Hz) of the uneffected hemisphere at 7 consecutive days

Treatment:

Device: navigated repetitive transcranial magnetic stimulation

Procedure: physical therapy

sham group

Sham Comparator group

Description:

15 minutes sham stimulation of the uneffected hemisphere at 7 consecutive days

Treatment:

Procedure: physical therapy