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Stress and Emotional Memory (SEME)

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stress Disorders, Post-Traumatic

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects aged 13-18 years
  • Informed consent signed by the legal representative and adolescents (e) itself.
  • Speaking French as their mother tongue
  • patients:subjects with a history of psychological trauma (eg, accidents of public roads (without head trauma), physical or sexual violence) recruited in the care services of hospitals, the diagnosis of chronic PTSD is made using a standardized interview (SCID).
  • Healthy controls : subjects who do not have a history of psychological trauma, nor PTSD

Exclusion Criteria:

  • ASD, schizophrenia, ADHD
  • Head injury with loss of consciousness
  • Regular or recent use of alcohol or drugs
  • chronic neurological or endocrine disorder
  • use of medication that could interfere with the mnemonic or metabolic measurements (psychotropic, hypnotics, anxiolytics, neuroleptics, benzodiazepines, drugs, antiepileptics anti-inflammatory, anti-histamines, central analgesics and muscle relaxants)
  • Contraindications to MRI (claustrophobia, metallic object intracorporal)
  • Manual Predominance left
  • Severe mental retardation evaluated using two subtests from the WISC-IV scales and WAIS III
  • Reading Disorders valued using the read speed test

Sites / Locations

  • Service de Pédopsychiatrie

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

PTSD group

Healthy Volunteers

Arm Description

PTSD group

Healthy Volunteers, age-matched controls.

Outcomes

Primary Outcome Measures

Amplitude of the BOLD fMRI signal measured at rest and during cognitive tasks (activation)

Secondary Outcome Measures

Full Information

First Posted
July 27, 2015
Last Updated
July 28, 2015
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT02510755
Brief Title
Stress and Emotional Memory
Acronym
SEME
Official Title
Stress and Emotional Memory : Functional Neuroanatomy of Post-traumatic Stress Disorder in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A broad group of disorders is associated with severe stress existence in children or adolescents. The most characteristic result, and one of the most serious being the state of post-traumatic stress disorder (PTSD), whose main source consists of physical or sexual violence, and to a lesser extent, accidents public road or natural disaster, whose child was the subject or witness. PTSD is associated with a deleterious effect on cognition and including the mnemonic operation. The painful reminder of the traumatic event is one of the most disabling symptoms. However, there are many other memory disorders that experimental studies gradually update. They maintain a close link with emotional regulation that disturbed you know if PTSD. However the majority of studies on emotion and cognition and their relationship with brain activity took adult subject. Work in adolescents are few on the morphological study, on rare neurobehavioral and reduced to two studies of functional neuroimaging. Contrary to what is observed in adults, morphological studies report consistently, no reduction in hippocampal volume. There is no study in the idle state. Two studies in functional MRI, the first highlighted in PTSD patients inhibition of the activity of the anterior cingulate cortex (ACC) to stimuli such as to evoke the trauma, a second reported increased activity in the prefrontal cortex Median (mPFC) in a inhibition. The objective task of our study is to evaluate the impact of psychological trauma on brain structures involved in the emotional component of the memory (amygdala, hippocampus, prefrontal cortex in particular). For this, the investigators will take in 33 adolescents, including patients with posttraumatic symptomatology and matched controls free of trauma age, several neuroimaging exams, anatomical and functional. The functional review will include some rest and another in activation during episodic memory task designed to assess the influence of self-perception on memory impairment observed in patients. The investigators will check, for each group of patients and controls, the involvement of cortical structures in relation to the regulation of emotional memory (CCA, amygdala and hippocampus). The anatomy of the hippocampus benefit specific imaging methods developed in the unit INSERM U923. Endocrine correlates of stress tests will be studied by a fully-traumatic by salivary cortisol sampling. This research will clarify the mechanisms involved in emotional and memory impairments secondary to psychological trauma, their relationship with self (judgment and self-esteem) and studying their morphological substrates. A longer-term goal is to offer help in the diagnosis and monitoring of young patients with posttraumatic symptomatology.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PTSD group
Arm Type
Other
Arm Description
PTSD group
Arm Title
Healthy Volunteers
Arm Type
Other
Arm Description
Healthy Volunteers, age-matched controls.
Intervention Type
Other
Intervention Name(s)
MRI
Primary Outcome Measure Information:
Title
Amplitude of the BOLD fMRI signal measured at rest and during cognitive tasks (activation)
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects aged 13-18 years Informed consent signed by the legal representative and adolescents (e) itself. Speaking French as their mother tongue patients:subjects with a history of psychological trauma (eg, accidents of public roads (without head trauma), physical or sexual violence) recruited in the care services of hospitals, the diagnosis of chronic PTSD is made using a standardized interview (SCID). Healthy controls : subjects who do not have a history of psychological trauma, nor PTSD Exclusion Criteria: ASD, schizophrenia, ADHD Head injury with loss of consciousness Regular or recent use of alcohol or drugs chronic neurological or endocrine disorder use of medication that could interfere with the mnemonic or metabolic measurements (psychotropic, hypnotics, anxiolytics, neuroleptics, benzodiazepines, drugs, antiepileptics anti-inflammatory, anti-histamines, central analgesics and muscle relaxants) Contraindications to MRI (claustrophobia, metallic object intracorporal) Manual Predominance left Severe mental retardation evaluated using two subtests from the WISC-IV scales and WAIS III Reading Disorders valued using the read speed test
Facility Information:
Facility Name
Service de Pédopsychiatrie
City
Caen
ZIP/Postal Code
14000
Country
France

12. IPD Sharing Statement

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Stress and Emotional Memory

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