Impact of nrTMS Therapy on the Progress of Neurorehabilitation

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

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

Study Overview

• Status: Unknown
• Conditions: Transcranial Magnetic Stimulation, Repetitive
• Intervention / Treatment: Procedure: physical therapy; Device: navigated repetitive transcranial magnetic stimulation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81675
      • Recruiting
      • Department of Neurosurgery
      • Contact: Sandro M Krieg, MD, MBA; Email: sandro.krieg@tum.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Investigators: Principal Investigator: Sandro M. Krieg, MD, Department of Neurosurgery, School of Medicine, TU Munich

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): June 11, 2019
• Last Update Submitted That Met QC Criteria: June 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 12/15S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO