Effects of Treatment of PTSD on Reduced Recall for Fear Extinction

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Centre Hospitalier Universitaire de Nice
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01228253
First received: October 25, 2010
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

This preliminary study will examine the differential effects of rTMS on the recall of extinction of conditioned fear in patients suffering from PTSD (post-traumatic stress disorder ) compared with subjects without PTSD but with high risk of relapse.


Condition Intervention
Post-traumatic Stress Disorder
Device: rTMS: repetitive transcranial magnetic stimulation
Device: SHAM rTMS: repetitive transcranial magnetic stimulation is off

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of Treatment of Post-traumatic Stress Disorder on Reduced Recall for Fear Extinction

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • prefrontal hyperactivation [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
    recall test of extinction (at D21)


Secondary Outcome Measures:
  • neuropsychological tests [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
    two other tests will indirectly assess prefrontal hyperactivation (emotional Stroop and attentional bias)


Estimated Enrollment: 18
Study Start Date: November 2011
Estimated Study Completion Date: September 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Safe voluntary.
No Intervention: 2
patient with psychotrauma but without PSTD and without any psychiatric trouble at the time of inclusion
No Intervention: 3
patient with psychotrauma and PTSD (post-traumatic stress disorder) and in full remission at the time of inclusion
No Intervention: 4.3
patient with psychotrauma and with activ PTSD (post-traumatic stress disorder)at the time of inclusion
Sham Comparator: 4.2
patient with psychotrauma and with activ PTSD (post-traumatic stress disorder)at the time of inclusion
Device: SHAM rTMS: repetitive transcranial magnetic stimulation is off
patients will be treated with rTMS at 10 Hz (D3 to D7 and D10-D14, 1 session / day with the stimulator on off
Other Name: SHAM rTMS: repetitive transcranial magnetic stimulation
Experimental: 4.1
patient with psychotrauma and with activ PTSD (post-traumatic stress disorder)at the time of inclusion
Device: rTMS: repetitive transcranial magnetic stimulation
patients will be treated with rTMS at 10 Hz (D3 to D7 and D10-D14, 1 session / day)

Detailed Description:

It is estimated that nearly 70% of individuals will experiment at least once in their life a traumatic event (eg war, natural disaster, accident or assault). The psychotrauma, whose symptoms (including revivalism, hypersensitivity to the environment, anxiety, avoidance behavior), may be sustainable and thus constitute a posttraumatic stress disorder (PTSD). One characteristic of PTSD can be studied in the laboratory is the lack of recall of extinction of conditioned fear, caused largely by a lack of induction of hyperactivation in the prefrontal cortex. Knowing that this hyperactivation may occur in some cases of remission of symptoms of PTSD, it is possible that the deficit in recall of extinction is lifted in such cases. This idea is also supported by animal models showing that the induction of natural or artificial prefrontal hyperactivation facilitates the recall of extinction. However, no study has yet addressed so far the effects of different treatments (conventional: pharmacotherapy and psychotherapy, or rTMS: repetitive transcranial magnetic stimulation) for PTSD, supposed to induce prefrontal hyperactivation and avoid the recall deficit of extinction of conditioned fear. The persistence of this deficit beyond the remission of PTSD symptoms could represent a situation with a high risk of relapse.

Objective. Our main objective is to examine performance in recall of extinction of conditioned fear on the one hand, in patients in remission of PTSD after conventional treatment and, secondly, in patients who received rTMS at 10 Hz

Population: THIS PRELIMINARY STUDY will include 9 patients with PTSD, 3 individuals in remission from PTSD, 3 psychotraumatized subjects without secondary PTSD and 3 individuals without a history of psychotrauma. These groups will be matched for age, sex and sociocultural level.

Method: All studies will be conducted at the Nice University Hospital. The pre-inclusion visit (D-7), including different clinical evaluations (MINI-DSM-IV, CAPS, PDI, Hamilton Depression Scale and Covi Anxiety), will be held at the Emergency Psychiatric Unit (Hospital Saint-Roch). The study will take place at the Psychiatry University Department and at the Neurology Exploration Department (Hospital Pasteur), where the subjects will have other clinical assessments (at D0, D17-D19, D21), the conditioning test and extinction (day 0) and recall test of extinction (at D21). The fear conditioning (measured by increases in heart rate and skin conductance) corresponds to presentations coupled with an image and tactile stimulation (the intensity of which will be chosen by the subject), while sessions of extinction and extinction recall that correspond to presentations of the image alone (without tactile stimulation). In addition to these sessions, one third of PTSD patients will be treated with rTMS at 10 Hz (D3 to D7 and D10-D14, 1 session / day), another third with placebo treatment and one third without treatment. Eventually (D21), two other tests will indirectly assess prefrontal hyperactivation (emotional Stroop and attentional bias) and self-questionnaires will be performed in all subjects immediately after the recall of extinction.

The persistent failure to recall extinction in some individuals in remission from PTSD would sign the maintenance of prefrontal dysfunction, and therefore a high risk of relapse. The induction of hyperactivation using prefrontal rTMS at 10 Hz would not only reduce symptoms of PTSD, but also reduce the risk of recurrence of these symptoms.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • French mother tongue
  • major
  • patient out of hospital
  • patient with health insurance

Exclusion Criteria:

  • patient with dysthymia
  • alcohol dependence, drug dependence
  • acute or chronic psychosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228253

Contacts
Contact: Michel BENOIT, PhD benoit.m@chu-nice.fr

Locations
France
Chu de Nice Recruiting
Nice, France, 06000
Contact: Michel BENOIT, M.D., PhD       benoit.m@chu-nice.fr   
Principal Investigator: Michel Benoit, M.D., PhD         
Sub-Investigator: Frédérique JOVER, M.D.         
Sub-Investigator: Virginie BUISSE, M.D, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Michel BENOIT, PhD psychiatry department, Nice University Hospital
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01228253     History of Changes
Other Study ID Numbers: 10-PP-05
Study First Received: October 25, 2010
Last Updated: February 20, 2013
Health Authority: France: French Data Protection Authority
France: Institutional Ethical Committee
France: Direction Générale de la Santé

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 14, 2014