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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)

Primary Purpose

Patients With Resistant Depressive Disorders

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
rTMS BA9/BA46
rTMS BA46/BA9
brain MRI
Medical evaluation
Psychological assessment
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Resistant Depressive Disorders

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Dijon Bourogne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

BA9/BA46

BA46/BA9

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 31, 2018
Last Updated
August 31, 2018
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT03656900
Brief Title
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.
Acronym
rTMS
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2010 (Actual)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Resistant Depressive Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BA9/BA46
Arm Type
Experimental
Arm Title
BA46/BA9
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
rTMS BA9/BA46
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
rTMS BA46/BA9
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
brain MRI
Intervention Description
T1 weighted full-head high-resolution MRI with 1 mm seam cuts and sagittal orientation.
Intervention Type
Other
Intervention Name(s)
Medical evaluation
Intervention Description
complete evaluation with 6 scales (HDRS, MADRS, Beck, CGI, COVI, UKU)
Intervention Type
Other
Intervention Name(s)
Psychological assessment
Intervention Description
Subjective Life Profile Assessment (SLPA) and Helping Alliance Assessment
Primary Outcome Measure Information:
Title
The remission rate
Description
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.
Time Frame
Through study completion, an average of 11 weeks.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chu Dijon Bourogne
City
Dijon
ZIP/Postal Code
21000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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.

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