Coupling Repetitive Transcranial Magnetic Stimulation With a Neuronavigation System in Treatment Resistant Depression (TMS)
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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 |
- Response [ Time Frame: Day 44 ] [ Designated as safety issue: No ]Response defined as at least 50% reduction in the MADRS score.
- 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: | November 2014 |
| Estimated Primary Completion Date: | November 2014 (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 :
Devices :
|
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 :
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 |
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| Contact: Bruno Millet, MD PhD | bruno.millet@univ-rennes1.fr |
| 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 | |
| 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: | November 21, 2012 |
| 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 Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013