NCT01677078

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

January 21, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2017

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

4.2 years

First QC Date

August 29, 2012

Last Update Submit

August 28, 2018

Conditions

Treatment Resistant Depression

Keywords

Major depressive disorderrTMSNeuronavigation

Outcome Measures

Primary Outcomes (1)

  • Response

    Response defined as at least 50% reduction in the MADRS score.

    Day 44

Secondary Outcomes (5)

  • Response

    Day 14

  • Remission

    Day 14 Day 44

  • MADRS

    Day 0, day 14 and day 44

  • BDI

    Day 0 Day 14 Day 14

  • ERD

    Day 0 Day 14 day 44

Study Arms (2)

Neuronavigation system

EXPERIMENTAL

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

Standard localisation method

SHAM COMPARATOR

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

Interventions

Neuronavigation systemDEVICE

Neuronavigation

Also known as: Syneika One (Syneika, France)
Neuronavigation system
Standard localisation methodDEVICE

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

Standard localisation method

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centre Santé Mentale Angevin CESAME

Angers, 49130, France

Location

CHU de Brest

Brest, 29200, France

Location

Etablissement Public de Santé Mentale

Quimperlé, 29300, France

Location

CHGR

Rennes, 35000, France

Location

EPSM Morbihan

Saint-Avé, 56890, France

Location

Related Publications (1)

  • Millet B, Harika-Germaneau G, Maatoug R, Naudet F, Reymann JM, Turmel V, Batail JM, Soulabaille J, Jaafari N, Drapier D. Repetitive Transcranial Magnetic Stimulation targeted with MRI based neuro-navigation in major depressive episode: a double-blind, multicenter randomized controlled trial. PLoS One. 2025 May 27;20(5):e0317597. doi: 10.1371/journal.pone.0317597. eCollection 2025.

    PMID: 40424301DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-ResistantDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Bruno Millet, MD PhD

    CHU Rennes

    PRINCIPAL INVESTIGATOR

  • Jean Michel Reymann, PhD

    CHU Rennes

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2012

First Posted

August 31, 2012

Study Start

January 21, 2013

Primary Completion

March 25, 2017

Study Completion

March 25, 2017

Last Updated

August 31, 2018

Record last verified: 2018-08

Locations

FR(5)