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出境医 / 临床实验 / Impact of nrTMS Therapy on the Progress of Neurorehabilitation

Impact of nrTMS Therapy on the Progress of Neurorehabilitation

Study Description
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.

Study Design
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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
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
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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
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE May 17, 2019
First Posted Date  ICMJE June 11, 2019
Last Update Posted Date June 11, 2019
Actual Study Start Date  ICMJE June 2015
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2019) 		Change of Fugl-Meyer Assessment (FMA) [ Time Frame: Between first day of intervention and 3-months follow up ]
Assessment upper extremity
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of nrTMS Therapy on the Progress of Neurorehabilitation
Official Title  ICMJE Evaluation of the Benefit of Navigated Repetitive Transcranial Magnetic Stimulation for Therapy of Surgery-related Motor Deficits in Brain Tumor Patients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Transcranial Magnetic Stimulation, Repetitive
Intervention  ICMJE
  • Device: navigated repetitive transcranial magnetic stimulation
  • Procedure: physical therapy
Study Arms  ICMJE
  • Active Comparator: nrTMS group
    15 minutes low-frequency nrTMS (1 Hz) of the uneffected hemisphere at 7 consecutive days
    Interventions:
    • 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
    Intervention: Procedure: physical therapy
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 May 11;14(4):780-787. doi: 10.1016/j.brs.2021.04.026. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 10, 2019) 		39
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03982329
Other Study ID Numbers  ICMJE 12/15S
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sandro M. Krieg, Technische Universität München
Study Sponsor  ICMJE Technische Universität München
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sandro M. Krieg, MD Department of Neurosurgery, School of Medicine, TU Munich
PRS Account Technische Universität München
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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