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Clinical Trials/NCT03990064
NCT03990064
Terminated
Not Applicable

Exploration of Cerebral Metabolism and Connectivity in Post Traumatic Stress Disorder (PTSD): Exploratory Study of Neurofunctional Modulation of Emotions by Music Therapy

Institut de Recherche Biomedicale des Armees1 site in 1 country15 target enrollmentFebruary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress Disorder, Post Traumatic
Sponsor
Institut de Recherche Biomedicale des Armees
Enrollment
15
Locations
1
Primary Endpoint
change in PTSD symptoms
Status
Terminated
Last Updated
3 years ago

Overview

Brief Summary

PTSD is a debilitating mental disorder that may develop after experiencing or witnessing a life-threatening event. With appropriate care, treatment efficiency is variable and around 20% of the patients do not respond to psychological treatment. Complementary treatments are needed.

as PTSD implied autonomic nervous system (ANS) dysfonction, complementary treatment focusing on ANS regulation, as welle as musicotherapy, may have an interest.

Detailed Description

The aim is to evaluate the impact of musicotherapy on PTSD symptoms, and severity using a RCT Symptoms will be evaluated using questionaires (PCL and quality of life) severity will be measured using neurological soft signs assessment, connectomic functions and ANS regulation

Registry
clinicaltrials.gov
Start Date
February 1, 2020
End Date
July 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Institut de Recherche Biomedicale des Armees
Responsible Party
Principal Investigator
Principal Investigator

Marion Trousselard

principal investigator

Institut de Recherche Biomedicale des Armees

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • neurological diseases
  • addiction

Outcomes

Primary Outcomes

change in PTSD symptoms

Time Frame: change from PTSD symptoms at two months and at six months

questionnaire Posttraumatic CheckList 5 (PCL5; threshold =33)

Secondary Outcomes

  • change in neurological soft signs(change from neurological soft signs at two months and at six months)
  • change in effective connectomic(change from effective connectomic at two months and at six months)
  • Autonomous nervous system regulation(change from Autonomous nervous system regulation at two months and at six months)
  • change in biological stress(change from biological stress at two months and at six months)

Study Sites (1)

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