NCT02438163

Brief Summary

Neuroplasticity is supposed to be altered in patients suffering from a Major Depressive Disorder (MDD). Transcranial Magnetic Stimulation is a medical device which measures cerebral plasticity. Several parameters of cortical excitability are available for that purpose. These parameters are altered on patients wth MDD and these modifications are corrected after treatment. Therefore results in the studies are very heterogeneous. Theta Burst Stimulation (TBS) is a type a Transcranial Magnetic Stimulation (TMS) protocol and can induce cerebral plasticity. The cerebral plasticity induced by TBS was measured on a group of patients suffering from Asperger's disease (ASD) versus a control group. The plasticity was significantly different in patients with ASD. The aim of our study is to study the neuroplasticity induced by TBS on a patients with MDD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 21, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 8, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2018

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

3.9 years

First QC Date

April 8, 2015

Last Update Submit

February 24, 2018

Conditions

Depression

Keywords

Theta Burst Stimulation

Outcome Measures

Primary Outcomes (1)

  • Time needed for MEP amplitude to return to Baseline after TBS

    The primary outcome is determined by measuring the MEP size at 5/10/20/30/40/50/60/75/90/105/120 min post TBS. Then we determine when the MEP size comes back to the Baseline measure

    Baseline, up to 120 minutes post TBS

Secondary Outcomes (1)

  • Size-effect of modification of MEP size after TBS

    The secondary outcome is determined by measuring the MEP size 5/10/20/30/40/50/60/75/90/105/120 min post TBS

Study Arms (2)

Patients with MDD

EXPERIMENTAL

the group of depressed patients undergo 2 Theta Burst Stimulations : iTBS and cTBS. There is one session per stimulation. Cerebral Plasticity is measured after each stimulation for each session

Device: Theta Burst Stimulation

healthy Controls

EXPERIMENTAL

the group of healthy controls undergo 2 Theta Burst Stimulations : iTBS and cTBS. There is one session per stimulation. Cerebral Plasticity is measured after each stimulation for each session

Device: Theta Burst Stimulation

Interventions

Theta Burst StimulationDEVICE

During the first session, After determining the parameters of stimulation (stimulated target : part of the left motor cortex responsible for the contraction of the right first dorsal interosseous muscle ; Activity Motor Threshold (AMT) ; Intensity of Stimulation providing a Motor Evoked Potential (MEP) with an Amplitude of 1mV (MEP 1mV)), a Baseline consisting of 15 MEP (intensity MEP 1mV) is measured. Then each subjet receive a TBS protocol (cTBS or iTBS) (intensity of stimulation 80% of AMT). After receiving the stimulation, sets containing 10 MEP are regularly measured by each subject. During a second session, the same protocol is done again with the other TBS stimulation (cTBS or iTBS) the subject didn't get during the first session.

Patients with MDDhealthy Controls

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with MDD
  • MDD according to definition provided by the DSM V
  • No antidepressant Healthy Controls
  • No present psychiatric disease

You may not qualify if:

  • depression with Melancholic features
  • pregnancy
  • contra indication in the use of TMS (personal history of epilepsy, deep brain stimulation, vague nerve stimulation, pace maker, intracerebral lesion, pieces of metal Inside of the brain)
  • diseases with neurological effects (multiple sclerosis, Parkinson disease, HIV...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Vinatier

Lyon, Auvergne-Rhône-Alpes, 69678, France

Location

Related Publications (1)

  • Vignaud P, Damasceno C, Poulet E, Brunelin J. Impaired Modulation of Corticospinal Excitability in Drug-Free Patients With Major Depressive Disorder: A Theta-Burst Stimulation Study. Front Hum Neurosci. 2019 Feb 26;13:72. doi: 10.3389/fnhum.2019.00072. eCollection 2019.

    PMID: 30863297DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Emmanuel POULET, MD PhD

    Hôpital le Vinatier

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

April 8, 2015

First Posted

May 8, 2015

Study Start

March 21, 2014

Primary Completion

February 7, 2018

Study Completion

February 7, 2018

Last Updated

February 27, 2018

Record last verified: 2018-02

Locations

FR(1)