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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 : July 29, 2021
Sponsor:
Collaborator:
Brainsway
Information provided by (Responsible Party):
Friedemann Paul, Charite University, Berlin, Germany

Study Description
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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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: H-coil (Repetitive deep transcranial magnetic stimulation) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: prefrontal cortex (PFC)
rTMS with the H-coil to the prefrontal cortex (PFC)
 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)
Active Comparator: motor cortex
rTMS with the H-coil to the motor cortex
 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)
Sham Comparator: sham treatment
sham treatment
 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)


Outcome Measures
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Primary Outcome Measures :
  1. Safety [ Time Frame: 3x/week during treatment phase ]
    examination by physician, assessement of adverse events


Secondary Outcome Measures :
  1. Fatigue [ Time Frame: 3x/week during treatment period ]
    Assessment of Fatigue via Fatigue Severity Scale FSS

  2. Depressivity [ Time Frame: 3x/week during treatment period ]
    Assessment of Depressivity via Beck Depression Inventory BDI


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT01106365


Locations
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Germany
Charite University Berlin (NeuroCure Clinical Research Center NCRC)
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Brainsway
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Friedemann Paul, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01106365    
Other Study ID Numbers: rTMS in MS
First Posted: April 19, 2010    Key Record Dates
Last Update Posted: July 29, 2021
Last Verified: July 2021
Keywords provided by Friedemann Paul, Charite University, Berlin, Germany:
multiple sclerosis
fatigue
depressivity
repetitive deep transcranial magnetic stimulation
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases