Ignite Creation Date:
2024-05-06 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05121129
Status:
RECRUITING
Last Update Posted:
2022-12-19
First Post:
2021-10-13
Brief Title:
Treatment of Major Depression by rTMS on Dorsolateral Prefrontal Cortex Study of Underlying Mechanisms
Sponsor:
Centre Hospitalier Universitaire de Besancon
Organization:
Centre Hospitalier Universitaire de Besancon
Study Overview
Official Title:
Treatment of Major Depression by Magnetic Stimulation Repeated Transcranial on Prefrontal Cortex Study of Underlying Mechanisms
Status:
RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEPSTIM
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
Detailed Description:
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 375 times and remission 252 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 95 minutesday 1800 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
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 95 minutesday 1800 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None