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

R

Rennes University Hospital

Status

Completed

Conditions

Depressive Disorder, Major

Treatments

Other: nurse semi-structured interview
Other: Music & Relaxation with eyes closed

Study type

Interventional

Funder types

Other

Identifiers

NCT03436823
35RC14_9783_DESTIMCARE

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

R.TMS + nurse semi-structured interview
Experimental group
Description:
Repeated Transcranial Magnetic Stimulation sessions associated with nurse semi-structured interview
Treatment:
Other: nurse semi-structured interview
R.TMS + Music & Relaxation
Sham Comparator group
Description:
Repeated Transcranial Magnetic Stimulation sessions associated with music listening \& relaxation with eyes closed
Treatment:
Other: Music & Relaxation with eyes closed

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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