NCT01228253

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2010

Completed
1 year until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 30, 2015

Status Verified

September 1, 2015

Enrollment Period

10 months

First QC Date

October 25, 2010

Last Update Submit

September 29, 2015

Conditions

Post-traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

  • prefrontal hyperactivation

    recall test of extinction (at D21)

    Day 21

Secondary Outcomes (1)

  • neuropsychological tests

    Day 21

Study Arms (6)

1

NO INTERVENTION

Safe voluntary.

2

NO INTERVENTION

patient with psychotrauma but without PSTD and without any psychiatric trouble at the time of inclusion

3

NO INTERVENTION

patient with psychotrauma and PTSD (post-traumatic stress disorder) and in full remission at the time of inclusion

4.3

NO INTERVENTION

patient with psychotrauma and with activ PTSD (post-traumatic stress disorder)at the time of inclusion

4.2

SHAM COMPARATOR

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

4.1

EXPERIMENTAL

patient with psychotrauma and with activ PTSD (post-traumatic stress disorder)at the time of inclusion

Device: rTMS: repetitive transcranial magnetic stimulation

Interventions

rTMS: repetitive transcranial magnetic stimulationDEVICE

patients will be treated with rTMS at 10 Hz (D3 to D7 and D10-D14, 1 session / day)

4.1
SHAM rTMS: repetitive transcranial magnetic stimulation is offDEVICE

patients will be treated with rTMS at 10 Hz (D3 to D7 and D10-D14, 1 session / day with the stimulator on off

Also known as: SHAM rTMS: repetitive transcranial magnetic stimulation
4.2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • patient with dysthymia
  • alcohol dependence, drug dependence
  • acute or chronic psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Nice

Nice, 06000, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Michel BENOIT, PhD

    psychiatry department, Nice University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2010

First Posted

October 26, 2010

Study Start

November 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

September 30, 2015

Record last verified: 2015-09

Locations

FR(1)