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Coupling Repetitive Transcranial Magnetic Stimulation With a Neuronavigation System in Treatment Resistant Depression

NCT01677078 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2018-08-31

No results posted yet for this study

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.

Investigator's objective is to compare efficacy on mood of coil positioning based upon a neuronavigation device versus coil positioning based upon the standard method.

Conditions

Interventions

DEVICE

Neuronavigation system

Neuronavigation

DEVICE

Standard localisation method

Manual localisation of the DLPFC using the standard localisation method (i.e. the '5-cm method')

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Bruno Millet, MD PhD · CHU Rennes

  • Jean Michel Reymann, PhD · CHU Rennes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-21
Primary Completion
2017-03-25
Completion
2017-03-25

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01677078 on ClinicalTrials.gov