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Repetitive Deep Transcranial Magnetic Stimulation in Multiple Sclerosis (rTMS in MS)

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ClinicalTrials.gov Identifier: NCT01106365
Recruitment Status : Completed
First Posted : April 19, 2010
Last Update Posted : November 29, 2018
Sponsor:
Collaborator:
Brainsway
Information provided by (Responsible Party):
Friedemann Paul, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE April 16, 2010
First Posted Date  ICMJE April 19, 2010
Last Update Posted Date November 29, 2018
Study Start Date  ICMJE February 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2013)
Safety [ Time Frame: 3x/week during treatment phase ]
examination by physician, assessement of adverse events
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT01106365 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2013)
  • Fatigue [ Time Frame: 3x/week during treatment period ]
    Assessment of Fatigue via Fatigue Severity Scale FSS
  • Depressivity [ Time Frame: 3x/week during treatment period ]
    Assessment of Depressivity via Beck Depression Inventory BDI
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Repetitive Deep Transcranial Magnetic Stimulation in Multiple Sclerosis
Official Title  ICMJE Repetitive Deep Transcranial Magnetic Stimulation in Multiple Sclerosis - A Pilot Study to Evaluate Safety and Efficacy of Deep rTMS on Fatigue and Depressivity in Patients With Multiple Sclerosis
Brief Summary

Multiple sclerosis (MS) is a chronic-inflammatory autoimmune central nervous system disorder and a leading cause of neurological disability in younger adults in Western countries. Besides "classic" neurological symptoms both depressivity and fatigue are among the most frequent symptoms in MS, affecting up to 90% of patients at onset or during the course of the disease. Neither are the psychological and immunological backgrounds of both well understood, nor are there numerous controlled therapeutic trials which would offer convincing treatment options for fatigue and depressivity in MS.

Transcranial magnetic stimulation (TMS) has been frequently used to investigate altered hemispheric and inter-hemispheric connectivity in MS. Recently, first therapeutic trials have been performed to address specific MS-related symptoms by TMS. Koch et al. demonstrated an improvement of hand dexterity following repetitive TMS, and Centonze and colleagues showed reduced spasticity following TMS.

Recently, a specific coil for the stimulation of deeper brain regions including the deep nuclei was developed, the so-called H-coil. It successfully stimulates deeper (pre-frontal) brain regions. Stimulation with this coil has been shown to be safe and well tolerated in healthy volunteers, and in patients suffering from major depression.

The aim of this project is to apply deep TMS with the H-coil to the prefrontal cortex (PFC) of MS patients. The PFC is the region at which stimulation is aimed in previous depression studies as this brain region has been shown to play a relevant role in affective disorders. It is the primary aim of this study, to evaluate the safety and tolerability of deep TMS with the H-coil in MS patients with fatigue or depressivity.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Device: H-coil (Repetitive deep transcranial magnetic stimulation)
Repetitive deep transcranial magnetic stimulation of prefrontal cortex or motor cortex or sham stimulation
Other Name: H-coil (Brainsway LTD., 19 Hartom Str., Jerusalem, Israel)
Study Arms  ICMJE
  • Experimental: prefrontal cortex (PFC)
    rTMS with the H-coil to the prefrontal cortex (PFC)
    Intervention: Device: H-coil (Repetitive deep transcranial magnetic stimulation)
  • Active Comparator: motor cortex
    rTMS with the H-coil to the motor cortex
    Intervention: Device: H-coil (Repetitive deep transcranial magnetic stimulation)
  • Sham Comparator: sham treatment
    sham treatment
    Intervention: Device: H-coil (Repetitive deep transcranial magnetic stimulation)
Publications * Gaede G, Tiede M, Lorenz I, Brandt AU, Pfueller C, Dörr J, Bellmann-Strobl J, Piper SK, Roth Y, Zangen A, Schippling S, Paul F. Safety and preliminary efficacy of deep transcranial magnetic stimulation in MS-related fatigue. Neurol Neuroimmunol Neuroinflamm. 2017 Dec 13;5(1):e423. doi: 10.1212/NXI.0000000000000423. eCollection 2018 Jan.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2010)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female patients with clinically definite MS according to Polman
  • Age 18 to 60
  • EDSS 0 to 6
  • Relapse-free > 30 days prior to inclusion
  • Stable immunomodulatory or immunosuppressive therapy or treatment-naïve for > 3 months prior to inclusion
  • In case of treatment with antidepressants: stable therapy > 3 months
  • A score of ≥ 4 on the FSS (fatigue severity scale)8 or
  • A score of ≥ 12 on the Beck Depression Inventory (BDI)
  • Highly effective methods of birth control for females

Exclusion Criteria:

  • Personal or family history of epilepsy, brain tumor, brain injury
  • History of metallic particles in the eye or head outside the mouth
  • Cardiac pacemakers, implanted neurostimulators, cochlear implants, implanted medication pumps
  • History of drug or alcohol abuse
  • Pregnancy
  • Relapse of MS < 30 days prior to inclusion
  • I.v. corticosteroid treatment < 30 days prior to inclusion
  • Change of immunomodulatory therapy < 30 days prior to inclusion
  • Change of antidepressant therapy < 3 months prior to inclusion
  • Comedication with neuroleptics and tricyclic antidepressants (amitriptyline etc.) during the entire study
  • patients with increased intracranial pressure (which lowers seizure threshold)
  • intracardiac lines
  • significant heart disease
  • bipolar disorder
  • history of stroke or other brain lesions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT01106365
Other Study ID Numbers  ICMJE rTMS in MS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Friedemann Paul, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Brainsway
Investigators  ICMJE Not Provided
PRS Account Charite University, Berlin, Germany
Verification Date November 2018

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