Impact of nrTMS Therapy on the Progress of Neurorehabilitation

Transcranial Magnetic Stimulation, Repetitive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03982329
• Other study ID #: 12/15S
• Status: Recruiting
• Phase: N/A
• Start date: June 2015
• Est. completion date: July 2019

Study information

• Verified date: June 2019
• Source: Technische Universität München
• Contact: Sandro M. Krieg, MD
• Phone: +498941402151
• Email: sandro.krieg[@]tum.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: July 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Transcranial Magnetic Stimulation, Repetitive

Intervention

Device:
• navigated repetitive transcranial magnetic stimulation

Procedure:
• physical therapy

Locations

Country	Name	City	State
Germany	Department of Neurosurgery	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Fugl-Meyer Assessment (FMA)	Assessment upper extremity	Between first day of intervention and 3-months follow up
Secondary	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
Secondary	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
Secondary	Jebsen Taylor Hand Function Test (JTHFT)	Functionality upper extremity	First day of intervention = postoperatively, after the 7th day of intervention and after 3 months
Secondary	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