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.

NCT03656900 | Completed Phase 2

• 1 other identifier: TROJAK 2009
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patients With Resistant Depressive Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

BA9/BA46

EXPERIMENTAL

Device: rTMS BA9/BA46; Radiation: brain MRI; Other: Medical evaluation; Other: Psychological assessment

BA46/BA9

EXPERIMENTAL

Device: rTMS BA46/BA9; Radiation: brain MRI; Other: Medical evaluation; Other: Psychological assessment

Interventions

rTMS BA9/BA46 DEVICE

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.

BA9/BA46

rTMS BA46/BA9 DEVICE

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.

BA46/BA9

brain MRI RADIATION

T1 weighted full-head high-resolution MRI with 1 mm seam cuts and sagittal orientation.

BA46/BA9; BA9/BA46

Medical evaluation OTHER

complete evaluation with 6 scales (HDRS, MADRS, Beck, CGI, COVI, UKU)

BA46/BA9; BA9/BA46

Psychological assessment OTHER

Subjective Life Profile Assessment (SLPA) and Helping Alliance Assessment

BA46/BA9; BA9/BA46

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

MeSH Terms

Interventions

Independent Medical Evaluation

Intervention Hierarchy (Ancestors)

Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 4, 2018
• Study Start: February 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: October 1, 2013
• Last Updated: September 4, 2018

Record last verified: 2018-08

Locations

FR (1)