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NCT Number: NCT01106365

Repetitive Deep Transcranial Magnetic Stimulation in 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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Behavioral Symptoms Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Depression Fatigue Immune System Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charite University Berlin (NeuroCure Clinical Research Center NCRC)

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

H-coil (Repetitive deep transcranial magnetic stimulation)

Device

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)

Primary outcomes

  1. Safety

    Time frame: 3x/week during treatment phase

    examination by physician, assessement of adverse events

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Brainsway

Registry information

Official study 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

Acronym: rTMS in MS

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 19, 2010
Registry last updated
Jul 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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