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.
NCT ID: NCT03656900
Last Updated: 2018-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
17 participants
INTERVENTIONAL
2010-02-28
2013-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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BA9/BA46
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.
brain MRI
T1 weighted full-head high-resolution MRI with 1 mm seam cuts and sagittal orientation.
Medical evaluation
complete evaluation with 6 scales (HDRS, MADRS, Beck, CGI, COVI, UKU)
Psychological assessment
Subjective Life Profile Assessment (SLPA) and Helping Alliance Assessment
BA46/BA9
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.
brain MRI
T1 weighted full-head high-resolution MRI with 1 mm seam cuts and sagittal orientation.
Medical evaluation
complete evaluation with 6 scales (HDRS, MADRS, Beck, CGI, COVI, UKU)
Psychological assessment
Subjective Life Profile Assessment (SLPA) and Helping Alliance Assessment
Interventions
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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.
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.
brain MRI
T1 weighted full-head high-resolution MRI with 1 mm seam cuts and sagittal orientation.
Medical evaluation
complete evaluation with 6 scales (HDRS, MADRS, Beck, CGI, COVI, UKU)
Psychological assessment
Subjective Life Profile Assessment (SLPA) and Helping Alliance Assessment
Eligibility Criteria
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Inclusion 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
* 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
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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Chu Dijon Bourogne
Dijon, , France
Countries
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Other Identifiers
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TROJAK 2009
Identifier Type: -
Identifier Source: org_study_id
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