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 August 2014 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01677078
First received: August 29, 2012
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Treatment Resistant Depression
Device: Neuronavigation system
Device: Standard localisation method
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of the Neuronavigation System Coupled With Repetitive Transcranial Magnetic Stimulation. A Randomized Double Blind Study

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Response [ Time Frame: Day 44 ] [ Designated as safety issue: No ]
    Response defined as at least 50% reduction in the MADRS score.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: November 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Device: Neuronavigation system
Neuronavigation
Other Name: Syneika One (Syneika, France)
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)

Device: Standard localisation method
Manual localisation of the DLPFC using the standard localisation method (i.e. the '5-cm method')

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677078

Contacts
Contact: Bruno Millet, MD PhD bruno.millet@univ-rennes1.fr

Locations
France
Centre Santé Mentale Angevin CESAME Not yet recruiting
Angers, France, 49130
Contact: Virginie Leon, MD         
Principal Investigator: Virginie Leon, MD         
CHU de Brest Not yet recruiting
Brest, France, 29200
Contact: Walter Michel, MD PhD         
Sub-Investigator: F STEPHAN, MD         
Principal Investigator: Michel Walter, MD PhD         
Etablissement Public de Santé Mentale Not yet recruiting
Quimperlé, France, 29300
Contact: C Bouche, MD         
Principal Investigator: C Bouche, MD         
CHGR Recruiting
Rennes, France, 35000
Contact: Bruno Millet, MD PhD         
Sub-Investigator: Nauczyciel Cecilia, MD         
Principal Investigator: Bruno Millet, MD PhD         
EPSM Morbihan Not yet recruiting
St Avé, France, 56890
Contact: Antoine Mourot, MD         
Principal Investigator: Antoine Mourot, MD         
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Bruno Millet, MD PhD CHU Rennes
Study Chair: Jean Michel Reymann, PhD CHU Rennes
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01677078     History of Changes
Other Study ID Numbers: 2011-A01272-39
Study First Received: August 29, 2012
Last Updated: August 8, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
Major depressive disorder
rTMS
Neuronavigation

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014