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

This study has been completed.
Sponsor:
Collaborator:
Brainsway LTD.
Information provided by (Responsible Party):
Friedemann Paul, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01106365
First received: April 16, 2010
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Multiple Sclerosis
 Device: H-coil (Repetitive deep transcranial magnetic stimulation)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Safety [ Time Frame: 3x/week during treatment phase ] [ Designated as safety issue: Yes ]
    examination by physician, assessement of adverse events


Secondary Outcome Measures:
  • Fatigue [ Time Frame: 3x/week during treatment period ] [ Designated as safety issue: No ]
    Assessment of Fatigue via Fatigue Severity Scale FSS

  • Depressivity [ Time Frame: 3x/week during treatment period ] [ Designated as safety issue: No ]
    Assessment of Depressivity via Beck Depression Inventory BDI


Enrollment: 36
Study Start Date: February 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106365

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

No publications provided

Responsible Party: Friedemann Paul, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01106365     History of Changes
Other Study ID Numbers: rTMS in MS
Study First Received: April 16, 2010
Last Updated: March 11, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
multiple sclerosis
fatigue
depressivity
repetitive deep transcranial magnetic stimulation

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013