Ignite Creation Date:
2024-05-06 @ 12:52 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01677078
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2012-08-29
Brief Title:
Coupling Repetitive Transcranial Magnetic Stimulation With a Neuronavigation System in Treatment Resistant Depression
Sponsor:
Rennes University Hospital
Organization:
Rennes University Hospital
Study Overview
Official Title:
Assessment of the Neuronavigation System Coupled With Repetitive Transcranial Magnetic Stimulation A Randomized Double Blind Study
Status:
COMPLETED
Status Verified Date:
2018-08
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:
TMS
Brief Summary:
Repetitive Transcranial Magnetic Stimulation rTMS is a non invasive technique which was shown to be effective in the treatment of major depression
The dorsolateral prefrontal cortex DLPFC is the anatomic target in rTMS studies and the standard manual 5-cm method for positioning the coil over DLPFC is the reference Nevertheless it has been criticized due to poor targeting accuracies attributed to inter-subject variability
Such an inaccuracy could have any therapeutic consequences as a decrease in rTMS efficacy
Preliminary findings suggest that a more reproductible and accurate method based upon a neuronavigation system could allow for a better efficacy This finding has to be replicated with sound methodology
Investigators objective is to compare efficacy on mood of coil positioning based upon a neuronavigation device versus coil positioning based upon the standard method
The dorsolateral prefrontal cortex DLPFC is the anatomic target in rTMS studies and the standard manual 5-cm method for positioning the coil over DLPFC is the reference Nevertheless it has been criticized due to poor targeting accuracies attributed to inter-subject variability
Such an inaccuracy could have any therapeutic consequences as a decrease in rTMS efficacy
Preliminary findings suggest that a more reproductible and accurate method based upon a neuronavigation system could allow for a better efficacy This finding has to be replicated with sound methodology
Investigators objective is to compare efficacy on mood of coil positioning based upon a neuronavigation device versus coil positioning based upon the standard method
Detailed Description:
Background
Repetitive Transcranial Magnetic Stimulation rTMS is a new tool for major depressive disorder
rTMS is a non invasive technique allowing for a localized stimulation of cerebral tissue cortex rTMS uses electromagnetic induction to induce weak electric currents using a rapidly changing magnetic field this can modify activity in specific or general parts of the brain
Meta-analyses have stated that rTMS appeared to be effective in the treatment of major depression despite any limits concerning sample sizes and methodological concerns
Studies have shown that this technique potentiates antidepressants treatment in combination therapy
It has received FDA approval for the management of major depressive disorder Stimulation parameters are numerous frequency intensity number of pulses and their effects are increasingly better understood in order to predict a better balance between efficacy and tolerability
The dorsolateral prefrontal cortex DLPFC is the target in repetitive transcranial magnetic stimulation and the standard manual 5-cm method for positioning the transcranial magnetic stimulation coil over DLPFC is the reference It has been criticized due to poor targeting accuracies attributed to inter-subject variability
Such an inaccuracy could have consequences as a decrease in rTMS efficacy Any preliminary findings suggest that a more reproductible and accurate method based upon a neuronavigation system could allow for a better efficacy This finding has to be replicated with sound methodology
Objectives
To compare efficacy on mood of coil positioning based upon a neuronavigation device versus coil positioning based upon the standard method
Investigators hypothesized that an accurate localization and stimulation of DLPFC using neuronavigation would be more effective than the less accurate standard method
A secondary objective is to compare the efficacy on patients self perception on psychomotor symptoms and the tolerability of the two methods
Repetitive Transcranial Magnetic Stimulation rTMS is a new tool for major depressive disorder
rTMS is a non invasive technique allowing for a localized stimulation of cerebral tissue cortex rTMS uses electromagnetic induction to induce weak electric currents using a rapidly changing magnetic field this can modify activity in specific or general parts of the brain
Meta-analyses have stated that rTMS appeared to be effective in the treatment of major depression despite any limits concerning sample sizes and methodological concerns
Studies have shown that this technique potentiates antidepressants treatment in combination therapy
It has received FDA approval for the management of major depressive disorder Stimulation parameters are numerous frequency intensity number of pulses and their effects are increasingly better understood in order to predict a better balance between efficacy and tolerability
The dorsolateral prefrontal cortex DLPFC is the target in repetitive transcranial magnetic stimulation and the standard manual 5-cm method for positioning the transcranial magnetic stimulation coil over DLPFC is the reference It has been criticized due to poor targeting accuracies attributed to inter-subject variability
Such an inaccuracy could have consequences as a decrease in rTMS efficacy Any preliminary findings suggest that a more reproductible and accurate method based upon a neuronavigation system could allow for a better efficacy This finding has to be replicated with sound methodology
Objectives
To compare efficacy on mood of coil positioning based upon a neuronavigation device versus coil positioning based upon the standard method
Investigators hypothesized that an accurate localization and stimulation of DLPFC using neuronavigation would be more effective than the less accurate standard method
A secondary objective is to compare the efficacy on patients self perception on psychomotor symptoms and the tolerability of the two methods
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None