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

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ClinicalTrials.gov Identifier: NCT03436823
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : April 28, 2021
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Rennes University Hospital

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Other: nurse semi-structured interview Other: Music & Relaxation with eyes closed Not Applicable

Detailed Description:

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. The Food & Drug Administration - 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. To our knowledge, 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Nurse Semi - Structured Interview Added to a Repeated Transcranial Magnetic Stimulation Improve Patients With Major Depressive Disorder? A Single Center Study, Randomized, Controlled and Single Blind
Actual Study Start Date : March 19, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: R.TMS + nurse semi-structured interview
Repeated Transcranial Magnetic Stimulation sessions associated with nurse semi-structured interview
 Other: nurse semi-structured interview
The first session of rTMS is D1. From the first meeting to D14 semi -structured interviews are set up
Sham Comparator: R.TMS + Music & Relaxation
Repeated Transcranial Magnetic Stimulation sessions associated with music listening & relaxation with eyes closed
 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


Outcome Measures
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Primary Outcome Measures :
  1. score of the Montgomery-Asberg Depression Rating Scale [ Time Frame: day 44 ]
    The ratings should be based on a clinical interview moving from broadly phrased questions about symptoms to more detailed ones which allow a precise rating of severity. The rater must decide whether the rating lies on the defined scale steps (0, 2, 4, 6) or between them (1, 3, 5). It is important to remember that it is only rare occasions that a depressed patient is encountered who cannot be rated on the items in the scale. If definite answers cannot be elicited from the patients, all relevant clues as well as information from other sources should be used as a basis for the rating in line with customary clinical practice.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients volunteers aged 18 to 70,
  • With the diagnosis of major depression, recurrent under the criteria of DSM.V,
  • With an unmodified antidepressant treatment for 3 weeks,
  • With a MADRS score greater than or equal to 21,
  • With or without neuronavigated rTMS sessions,
  • Informed and who have signed a consent.

Exclusion Criteria:

  • Patients with psychotic symptoms,
  • With alcohol dependence or other substances abuse,
  • With the strength criteria defined by the V stage for Classification of Thase & Rush,
  • Hospitalized without consent / or under legal protection for major.
  • With a high risk of suicide - item 10 of the MADRS> 3 in the absence of hospitalization,
  • With contraindications to the practice of MRI or rTMS due to previous seizures, neurological disorders and / or neurosurgical, metal prosthetic presence or foreign bodies pacemaker type intraocular ferromagnetic material,
  • Aged over 70 years due to cortical alteration,
  • Pregnancy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436823


Contacts
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Contact: Stéphane Brousse 33 2 99 33 39 37 stephanebrousse@gmail.com
Contact: Loïc Hespel 33 2 99 28 25 55 drc@chu-rennes.fr

Locations
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France
CHGR Recruiting
Rennes, France
Contact: Anne Hespel         
Principal Investigator: Dominique Drapier         
Sponsors and Collaborators
Rennes University Hospital
Ministry of Health, France
More Information
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03436823    
Other Study ID Numbers: 35RC14_9783_DESTIMCARE
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms