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Does Nurse Semi Structured Interview Added to a rTMS Improve Patients With Major Depressive Disorder?

NCT03436823 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-01-20

No results posted yet for this study

Summary

Repeated Transcranial Magnetic Stimulation - R.TMS - is currently part of the treatment for depressive illness. This non-invasive technique is designed to stimulate certain areas of the cerebral cortex involved in this pathology. FDA approved this treatment in routine for depressive illness. R.TMS still remains in assessment. Due to the heterogeneity of methods and the weakness of the cohorts therapeutic superiority can not concluded .

Stimulation parameters remain numerous even if a consensus is beginning to emerge. The therapeutic target is the left dorso - lateral prefrontal cortex. The lack of efficacy is probably due of the inaccuracy. The empirically location of the target does not take into account the inter-individual anatomical differences. The neuronavigation is becoming widespread in routine clinical practice.

The referent nurse stays with the patient all along the rTMS sessions. His role is to set up treatment, to ensure the safety and the well-being of the patient. An rTMS session is an average of 30 minutes and is a very special moment to create a specific therapeutic relationship.

No study was conducted to evaluate the therapeutic relationship. The assumption is made that rTMS with a semi - structured interview provides a qualitative and quantitative clinical response greater than a semi - structured rTMS without this nursing care. The investigators therefore propose to patients not receiving a semi-structured interview to listen to music with eyes closed.

Conditions

  • Depressive Disorder, Major

Interventions

OTHER

nurse semi-structured interview

The first session of rTMS is D1. From the first meeting to D14 semi -structured interviews are set up

OTHER

Music & Relaxation with eyes closed

The first session of rTMS is D1. From the first meeting to D14 music \& relaxation with eyes closed sessions are set up

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Dominique Drapier, MD · Centre Hospitalier Guillaume Régnier,

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-03-19
Primary Completion
2023-01-06
Completion
2023-01-06

Countries

  • France

Study Locations

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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 NCT03436823 on ClinicalTrials.gov