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

July 28, 2021 updated by: Friedemann Paul, Charite University, Berlin, Germany

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charite University Berlin (NeuroCure Clinical Research Center NCRC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • H-coil (Brainsway LTD., 19 Hartom Str., Jerusalem, Israel)
Sham Comparator: 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 Names:
  • H-coil (Brainsway LTD., 19 Hartom Str., Jerusalem, Israel)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 3x/week during treatment phase
examination by physician, assessement of adverse events
3x/week during treatment phase

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: 3x/week during treatment period
Assessment of Fatigue via Fatigue Severity Scale FSS
3x/week during treatment period
Depressivity
Time Frame: 3x/week during treatment period
Assessment of Depressivity via Beck Depression Inventory BDI
3x/week during treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Brainsway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

April 16, 2010

First Submitted That Met QC Criteria

April 16, 2010

First Posted (Estimate)

April 19, 2010

Study Record Updates

Last Update Posted (Actual)

July 29, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rTMS in MS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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