NCT05121129

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

October 13, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 16, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2023

Completed
Last Updated

December 19, 2022

Status Verified

December 1, 2022

Enrollment Period

1.4 years

First QC Date

October 13, 2021

Last Update Submit

December 15, 2022

Conditions

Depressive Disorder, Major

Keywords

depressioniTBSneuronal mechanismMRIEEG

Outcome Measures

Primary Outcomes (4)

  • Change from baseline connectivity with theta wave on EEG at D5 (immediate effect) :

    changes in brain connectivity will be analyzed with theta wave

    baseline (Day 0), Day 5 post-treatment

  • Change from baseline connectivity with beta wave in EEG at D5 (immediate effect)

    changes in brain connectivity will be analyzed with beta wave

    baseline (Day 0), Day 5 post-treatment

  • Change from baseline connectivity with P3 wave EEG at D5 (immediate effect)

    changes in brain connectivity will be analyzed with P3 wave

    baseline (Day 0), Day 5 post-treatment

  • Change from baseline connectivity with fMRI at D30 (prolonged effect) : Resting State Magnetic Resonance Imaging (MRI)

    Resting State MRI will allow us to investigate the functional connectivity in the brain, by looking at resting state networks

    baseline (Day 0), Day 30 post-treatment

Secondary Outcomes (13)

  • Severity of depressive symptoms evaluated by the clinician

    baseline (Day 0), Day 5 (end of iTBS sessions), Day 12 and Day 30 post-iTBS

  • Severity of depressive symptoms evaluated by the patient

    baseline (Day 0), Day 5 (end of iTBS sessions), Day 12 and Day 30 post-iTBS

  • Impulsivity

    baseline (Day 0), Day 5 (end of iTBS sessions), Day 12 and Day 30 post-iTBS

  • Average adjusted pump scores on the Balloon Analogue Risk Task (BART)

    baseline (Day 0), Day 12 post-iTBS

  • Delay Discounting

    baseline (Day 0), Day 5 (end of iTBS sessions), Day 12 and Day 30 post-iTBS

  • +8 more secondary outcomes

Study Arms (1)

iTBS

EXPERIMENTAL

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

Device: iTBS

Interventions

iTBSDEVICE

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)

iTBS

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Magali NICOLIER

Besançon, 25030, France

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Emmanuel HAFFEN, Professor

    Centre Hospitalier Universitaire de Besancon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuel HAFFEN, Professor

CONTACT

+33381218154emmanuel.haffen@univ-fcomte.fr

magali nicolier, PhD

CONTACT

+33381219007mnicolier@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2021

First Posted

November 16, 2021

Study Start

October 13, 2021

Primary Completion

March 9, 2023

Study Completion

April 9, 2023

Last Updated

December 19, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)