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Impact of nrTMS Therapy on the Progress of Neurorehabilitation

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ClinicalTrials.gov Identifier: NCT03982329
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Sandro M. Krieg, Technische Universität München

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

Condition or disease Intervention/treatment Phase
Transcranial Magnetic Stimulation, Repetitive Device: navigated repetitive transcranial magnetic stimulation Procedure: physical therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2/3 nrTMS, 1/3 sham
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Benefit of Navigated Repetitive Transcranial Magnetic Stimulation for Therapy of Surgery-related Motor Deficits in Brain Tumor Patients
Actual Study Start Date : June 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

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



Primary Outcome Measures :
  1. Change of Fugl-Meyer Assessment (FMA) [ Time Frame: Between first day of intervention and 3-months follow up ]
    Assessment upper extremity


Secondary Outcome Measures :
  1. Nine Hole Peg Test (NHPT) [ Time Frame: First day of intervention = postoperatively, after the 7th day of intervention and after 3 months ]
    Fine motor skills upper extremity

  2. National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: 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

  3. Jebsen Taylor Hand Function Test (JTHFT) [ Time Frame: First day of intervention = postoperatively, after the 7th day of intervention and after 3 months ]
    Functionality upper extremity

  4. Karnofsky Performance Status (KPS) [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982329


Contacts
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Contact: Sandro M. Krieg, MD +498941402151 sandro.krieg@tum.de
Contact: Sebastian Ille, MD +498941402151 sebastian.ille@tum.de

Locations
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Germany
Department of Neurosurgery Recruiting
Munich, Bavaria, Germany, 81675
Contact: Sandro M Krieg, MD, MBA       sandro.krieg@tum.de   
Sponsors and Collaborators
Technische Universität München
Investigators
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Principal Investigator: Sandro M. Krieg, MD Department of Neurosurgery, School of Medicine, TU Munich

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Responsible Party: Sandro M. Krieg, Attending Neurosurgeon, Technische Universität München
ClinicalTrials.gov Identifier: NCT03982329     History of Changes
Other Study ID Numbers: 12/15S
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No