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Treatment of Major Depression by rTMS on Dorsolateral Prefrontal Cortex: Study of Underlying Mechanisms

NCT ID: NCT05121129

Last Updated: 2022-12-19

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-13

Study Completion Date

2023-04-09

Brief Summary

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The study aims to evaluate the impact of repeated Transcranial Magnetic Stimulation (rTMS) on underlying neuronal mechanisms of adults suffering from major depression disorder (MDD). Short- and long-term effects are assessed by High-Resolution electroencephalography (HR-EEG) or Magnetic Resonance Imaging (MRI) records, experimental tasks and self-rated scales.

Detailed Description

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Depression is associated with functional and structural changes in the brain, notably in DLPFC (DorsoLateral PreFrontal Cortex). High-frequency rTMS (10 Hz) applied to the left DLPFC is associated with a response rate 3.75 times and remission 2.52 higher than placebo for the treatment of MDD with more reproducible results than those observed for the others rTMS stimulation modalities (low frequency, iTBS5). rTMS is validated as an indication for the treatment of MDD by all learned societies and regulatory authorities in a large number of countries, except in France. Limiting factors concern the lack of knowledge of the action mechanisms, due in particular to the absence of studies based on animal models, the focused application of TMS in rodents being a challenge that few teams have mastered. The rationale for the therapeutic use in the treatment of MDD is now based on some functional brain imaging data showing that rTMS induces a lasting change in brain activity at the site of stimulation (CPFDL) but also in remote interconnected areas such as the limbic region or the amygdala. The DEPSTIM clinical project is part of a translational project with a fundamental approach in rodents.

The main objective is to demonstrate that remission following rTMS of CPFDL occurs via the activation of CPFDL projections to these dysfunctional subcortical areas in MDD.

With a prospective, open design, this study aims to evaluate the impact of iTBS over the left DLPFC on neuronal mechanisms of adults suffering from MDD. Subjects will be submitted to 25 intermittent TBS (iTBS) stimulation sessions for five consecutive days (5 sessions of 9.5 minutes/day, 1,800 pulses per session, 90% of resting motor threshold, placed over the left DLPFC, as mentionned by Cole et al, 2018 (Stanford Neuromodulation Therapy: SNT)). Baseline measures will be compared to those obtained immediately after the end of sessions (Day 5 (D5): short-term effects with HR-EEG analysis), and 30 days (D30) later (long-term effects with MRI analysis).

Conditions

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Depressive Disorder, Major

Keywords

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depression iTBS neuronal mechanism MRI EEG

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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iTBS

Subjects suffering of MDD assigned to start the trial by 25 sessions of iTBS applied in left DLPFC

Group Type EXPERIMENTAL

iTBS

Intervention Type DEVICE

25 active iTBS sessions (5 sessions of 9.5 minutes/day, 1,800 pulses per session, 90% of resting motor threshold, placed over the left DLPFC)

Interventions

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iTBS

25 active iTBS sessions (5 sessions of 9.5 minutes/day, 1,800 pulses per session, 90% of resting motor threshold, placed over the left DLPFC)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of MDD (Diagnostic and Statistical Manual of Mental Disorders V \[DSM-V\] and (Mini International Neuropsychiatric Interview \[MINI\] criteria, QIDS-C16≥18)
* Right-handed
* No response at a first antidepressant
* Under AD ≥ 6 weeks
* No contraindications for rTMS and MRI
* Absence of addictive comorbidities
* Absence of severe progressive neurologic and/or somatic pathologies (specially tumors, neurodegenerative diseases)
* Inpatients or outpatients of Adult Psychiatric Department
* Signed informed consent form
* Subjects affiliated to or beneficiary from a French social security regime

Exclusion Criteria

* Subjects under 35 years old or over 65 years old
* Treated with over 4 AD for the current episode
* ECT or rTMS for current episode
* BZD or antiepileptic (except pregabalin up to 75 mg / d, zopiclone ≤7.5 mg / d)
* Left-handed
* Subject under measure of protection or guardianship of justice
* Presence of psychiatric comorbidities
* Subject beneficiary from a legal protection regime
* Subject unlikely to cooperate or low cooperation stated by investigator
* Subject not covered by social security
* Pregnant woman
* Subject being in the exclusion period of another study or provided for by the "National Volunteer File
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation de France

OTHER

Sponsor Role collaborator

iBRAIN

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuel HAFFEN, Professor

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Besancon

Locations

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Magali NICOLIER

Besançon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Emmanuel HAFFEN, Professor

Role: CONTACT

Phone: +33381218154

Email: [email protected]

magali nicolier, PhD

Role: CONTACT

Phone: +33381219007

Email: [email protected]

Facility Contacts

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Magali NICOLIER, PhD

Role: primary

Other Identifiers

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2020/477

Identifier Type: -

Identifier Source: org_study_id