Repetitive Deep Transcranial Magnetic Stimulation in Multiple Sclerosis

NCT01106365 | Completed

• 1 other identifier: rTMS in MS
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; fatigue; depressivity; repetitive deep transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• Safety

  examination by physician, assessement of adverse events

  3x/week during treatment phase

Secondary Outcomes (2)

• Fatigue

  3x/week during treatment period

• Depressivity

  3x/week during treatment period

Study Arms (3)

prefrontal cortex (PFC)

EXPERIMENTAL

rTMS with the H-coil to the prefrontal cortex (PFC)

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

motor cortex

ACTIVE COMPARATOR

rTMS with the H-coil to the motor cortex

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

sham treatment

SHAM COMPARATOR

sham treatment

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

Interventions

H-coil (Repetitive deep transcranial magnetic stimulation) DEVICE

Repetitive deep transcranial magnetic stimulation of prefrontal cortex or motor cortex or sham stimulation

Also known as: H-coil (Brainsway LTD., 19 Hartom Str., Jerusalem, Israel)

motor cortex; prefrontal cortex (PFC); sham treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients with clinically definite MS according to Polman
• Age 18 to 60
• EDSS 0 to 6
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Brainsway: collaborator

Study Sites (1)

Charite University Berlin (NeuroCure Clinical Research Center NCRC)

Berlin, 10117, Germany

Location

Related Publications (1)

• Gaede G, Tiede M, Lorenz I, Brandt AU, Pfueller C, Dorr 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.

  PMID: 29259998 RESULT

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue; Depression

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 16, 2010
• First Posted: April 19, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 29, 2021

Record last verified: 2021-07

Locations

DE (1)