Monocentric Pilot Study, for a Randomized, Crossover, Blinded Trial: Comparison of the Therapeutic Efficacy of Low Frequency Repeated Transcranial Magnetic Stimulation on Cortical Area 9 Compared to Brodmann Area 46 in the Treatment of Depressive Disorders. (rTMS)

Repetitive transcranial magnetic stimulation (rTMS) is a new therapeutic tool used in psychiatry. Non-invasive, well tolerated and requiring no premedication, it is performed on an outpatient basis. The principle of this technique is to stimulate the cerebral cortex from an electromagnetic coil placed on the scalp. Unlike electroconvulsive therapy, rTMS induces an electrical current on a well-defined region of the cerebral cortex.

In psychiatry, this technique is mainly considered in the treatment of depressive disorders resistant to antidepressant medication. The brain target, obtained from brain imaging data in depressed patients, is the dorsolateral prefrontal cortex (DLPFC). The Food and Drug Administration (FDA) has recognized the interest of rTMS for treating depressive disorders (October 7, 2008).

However, some stimulation parameters still need to be optimized before rTMS can be considered a therapeutic method in its own right and used routinely. Indeed, its effectiveness over time has not yet been evaluated, and rTMS has shown a lack of reproducibility between subjects [Foucher, 2007]. Finally, the therapeutic results of rTMS are very modest whatever the study [Daskalakis, 2008]. Additional studies are therefore needed to optimize stimulation parameters.

Study Overview

• Status: Completed
• Conditions: Patients With Resistant Depressive Disorders
• Intervention / Treatment: Device: rTMS BA9/BA46; Radiation: brain MRI; Other: Medical evaluation; Other: Psychological assessment; Device: rTMS BA46/BA9

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Chu Dijon Bourogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients with resistant depressive disorders (Hamilton-17-item scale > 22, failure ≥ 2 antidepressants) with at least one of the following criteria :

• venlafaxine treatment failure (unlike the national PHRC, patients who receive/have received venlafaxine treatment for the current depressive episode are included),
• therapeutic failure in PHRC national rTMS 2007,
• refusal to participate in the PHRC national rTMS 2007.

Exclusion Criteria:

• Bipolar disorders: type I or II,
• Depression with psychotic characteristics,
• Schizophrenia,
• Risky or harmful use of alcohol and/or an illicit psychoactive substance,
• Dependence on alcohol and/or an illicit psychoactive substance,
• Sick and hospitalized under duress or under legal protection (guardianship, curatorship),
• Contraindication to the practice of rTMS; personal history of seizures, history of neurological or neurosurgical pathologies, metallic prosthetic materials or foreign bodies (pacemaker, etc...),
• Contraindication to brain MRI,
• Pregnancy or breastfeeding in progress
• Resistance to Escitalopram

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BA9/BA46	Device: rTMS BA9/BA46; 10 sessions of low-frequency repeated transcranial magnetic stimulation over two weeks on cortical area 9, then 4 weeks wash-out, then 10 sessions of low-frequency repeated transcranial magnetic stimulation repeated low frequency over two weeks on cortical area 46.; Radiation: brain MRI; T1 weighted full-head high-resolution MRI with 1 mm seam cuts and sagittal orientation.; Other: Medical evaluation; complete evaluation with 6 scales (HDRS, MADRS, Beck, CGI, COVI, UKU); Other: Psychological assessment; Subjective Life Profile Assessment (SLPA) and Helping Alliance Assessment
Experimental: BA46/BA9	Radiation: brain MRI; T1 weighted full-head high-resolution MRI with 1 mm seam cuts and sagittal orientation.; Other: Medical evaluation; complete evaluation with 6 scales (HDRS, MADRS, Beck, CGI, COVI, UKU); Other: Psychological assessment; Subjective Life Profile Assessment (SLPA) and Helping Alliance Assessment; Device: rTMS BA46/BA9; 10 sessions of low-frequency repeated transcranial magnetic stimulation over two weeks on cortical area 46, then 4 weeks wash-out, then 10 sessions of low-frequency repeated transcranial magnetic stimulation repeated low frequency over two weeks on cortical area 9.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The remission rate	Compare the remission rates (decrease < 50% of the HDRS score / initial score) during neuronavigated stimulations on BA 9 and BA 46 compared to the average rate obtained during manual stimulation.	Through study completion, an average of 11 weeks.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: August 31, 2018
• First Submitted That Met QC Criteria: August 31, 2018
• First Posted (Actual): September 4, 2018

Study Record Updates

• Last Update Posted (Actual): September 4, 2018
• Last Update Submitted That Met QC Criteria: August 31, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: TROJAK 2009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No