Coupling Repetitive Transcranial Magnetic Stimulation With a Neuronavigation System in Treatment Resistant Depression (TMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01677078
First received: August 29, 2012
Last updated: December 24, 2013
Last verified: December 2013

August 29, 2012
December 24, 2013
November 2012
November 2014   (final data collection date for primary outcome measure)
Response [ Time Frame: Day 44 ] [ Designated as safety issue: No ]
Response defined as at least 50% reduction in the MADRS score.
Same as current
Complete list of historical versions of study NCT01677078 on ClinicalTrials.gov Archive Site
  • Response [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    Response is defined as at least 50% reduction in the MADRS score.
  • Remission [ Time Frame: Day 14 Day 44 ] [ Designated as safety issue: No ]
    Remission is defined as a MADRS score ≤ 8.
  • MADRS [ Time Frame: Day 0, day 14 and day 44 ] [ Designated as safety issue: No ]
    Description: It is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders.
  • BDI [ Time Frame: Day 0 Day 14 Day 14 ] [ Designated as safety issue: No ]
    It is a multiple-choice self-report inventory and one of the most widely used instruments for measuring the severity of depression.
  • ERD [ Time Frame: Day 0 Day 14 day 44 ] [ Designated as safety issue: No ]
    It is a 14-item questionnaire which psychiatrists use to measure the intensity of motor retardation.
Same as current
Not Provided
Not Provided
 
Coupling Repetitive Transcranial Magnetic Stimulation With a Neuronavigation System in Treatment Resistant Depression
Assessment of the Neuronavigation System Coupled With Repetitive Transcranial Magnetic Stimulation. A Randomized Double Blind Study

Repetitive Transcranial Magnetic Stimulation (rTMS) is a non invasive technique which was shown to be effective in the treatment of major depression.

The dorsolateral prefrontal cortex (DLPFC) is the anatomic target in rTMS studies and the standard (manual) '5-cm method' for positioning the coil over DLPFC is the reference. Nevertheless, it has been criticized due to poor targeting accuracies attributed to inter-subject variability.

Such an inaccuracy could have any therapeutic consequences as a decrease in rTMS efficacy.

Preliminary findings suggest that a more reproductible and accurate method, based upon a neuronavigation system could allow for a better efficacy. This finding has to be replicated with sound methodology.

Investigator's objective is to compare efficacy on mood of coil positioning based upon a neuronavigation device versus coil positioning based upon the standard method.

Background :

Repetitive Transcranial Magnetic Stimulation (rTMS) is a new tool for major depressive disorder.

rTMS is a non invasive technique allowing for a localized stimulation of cerebral tissue cortex. rTMS uses electromagnetic induction to induce weak electric currents using a rapidly changing magnetic field; this can modify activity in specific or general parts of the brain.

Meta-analyses have stated that rTMS appeared to be effective in the treatment of major depression despite any limits concerning sample sizes and methodological concerns.

Studies have shown that this technique potentiates antidepressants treatment in combination therapy.

It has received FDA approval for the management of major depressive disorder. Stimulation parameters are numerous (frequency, intensity, number of pulses) and their effects are increasingly better understood in order to predict a better balance between efficacy and tolerability.

The dorsolateral prefrontal cortex (DLPFC) is the target in repetitive transcranial magnetic stimulation and the standard (manual) '5-cm method' for positioning the transcranial magnetic stimulation coil over DLPFC is the reference. It has been criticized due to poor targeting accuracies attributed to inter-subject variability.

Such an inaccuracy could have consequences as a decrease in rTMS efficacy. Any preliminary findings suggest that a more reproductible and accurate method, based upon a neuronavigation system could allow for a better efficacy. This finding has to be replicated with sound methodology.

Objectives:

To compare efficacy on mood of coil positioning based upon a neuronavigation device versus coil positioning based upon the standard method.

Investigators hypothesized that an accurate localization and stimulation of DLPFC using neuronavigation would be more effective than the less accurate standard method.

A secondary objective is to compare the efficacy on patient's self perception, on psychomotor symptoms and the tolerability of the two methods.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Treatment Resistant Depression
  • Device: Neuronavigation system
    Neuronavigation
    Other Name: Syneika One (Syneika, France)
  • Device: Standard localisation method
    Manual localisation of the DLPFC using the standard localisation method (i.e. the '5-cm method')
  • Experimental: Neuronavigation system

    10 sessions of rTMS coupled with a neuronavigation system

    Description of 1 session of the rTMS protocol :

    • Frequency: 20Hz
    • Intensity: 110% of motor threshold
    • 80 train of 2 seconds duration
    • 10 seconds between two trains
    • 3200 pulses

    Devices :

    • rTMS: System Mag Pro (Magventure, Denmark)
    • Neuronavigation system: Syneika One (Syneika, France)
    Intervention: Device: Neuronavigation system
  • Sham Comparator: Standard localisation method

    10 sessions of rTMS with manual localisation of the DLPFC using the standard localisation method (i.e. the '5-cm method')

    Description of 1 session of the rTMS protocol :

    • Frequency: 20Hz
    • Intensity: 110% of motor threshold
    • 80 train of 2 seconds duration
    • 10 seconds between two trains
    • 3200 pulses

    Devices :

    - rTMS: System Mag Pro (Magventure, Denmark)

    Intervention: Device: Standard localisation method
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
November 2014
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients giving their consent;
  • Right handed;
  • Age > 18 and < 65;
  • With a DSM-IV diagnosis of MDD, single episode or recurrent;
  • With an antidepressant treatment unchanged in the 3 last weeks;
  • With an MADRS score ≥ 21;
  • Benzodiazepine treatments have to be avoided;

Exclusion Criteria:

  • Major depressive episode with psychotic characteristics;
  • A lifetime of the following axis 1 diagnoses: schizophrenia or substance use disorder (alcohol or other substance);
  • Stade 5 of Thase and Rush classification ;
  • Involuntary hospitalizations;
  • Patients under guardianship;
  • Outpatients in case of an increased risk of suicide as assessed by a MADRS item 10 > 3;
  • Contraindication for MRI or rTMS: a personal history of a seizure disorder, presence of neurologic or neurosurgical disorder, presence of ferromagnetic material (including intraocular) or metallic medical devices (pacemakers);
  • Pregnancy.
Both
18 Years to 65 Years
No
Contact: Bruno Millet, MD PhD bruno.millet@univ-rennes1.fr
France
 
NCT01677078
2011-A01272-39
No
Rennes University Hospital
Rennes University Hospital
Not Provided
Principal Investigator: Bruno Millet, MD PhD CHU Rennes
Study Chair: Jean Michel Reymann, PhD CHU Rennes
Rennes University Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP