Coupling Repetitive Transcranial Magnetic Stimulation With a Neuronavigation System in Treatment Resistant Depression
- Conditions
- Treatment Resistant Depression
- Interventions
- Device: Standard localisation methodDevice: Neuronavigation system
- Registration Number
- NCT01677078
- Lead Sponsor
- Rennes University Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 107
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard localisation method 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) Neuronavigation system 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)
- Primary Outcome Measures
Name Time Method Response Day 44 Response defined as at least 50% reduction in the MADRS score.
- Secondary Outcome Measures
Name Time Method BDI Day 0 Day 14 Day 14 It is a multiple-choice self-report inventory and one of the most widely used instruments for measuring the severity of depression.
ERD Day 0 Day 14 day 44 It is a 14-item questionnaire which psychiatrists use to measure the intensity of motor retardation.
Response Day 14 Response is defined as at least 50% reduction in the MADRS score.
Remission Day 14 Day 44 Remission is defined as a MADRS score ≤ 8.
MADRS Day 0, day 14 and day 44 Description: It is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders.
Trial Locations
- Locations (5)
Etablissement Public de Santé Mentale
🇫🇷Quimperlé, France
Centre Santé Mentale Angevin CESAME
🇫🇷Angers, France
CHU de Brest
🇫🇷Brest, France
CHGR
🇫🇷Rennes, France
EPSM Morbihan
🇫🇷St Avé, France