NCT01196624

Brief Summary

Subjects Forty consecutive patients fulfilling the DSM-IV diagnostic criteria for PTSD will be recruited from the inpatient and outpatient treatment programs at the Beer Sheva Mental Health Center. Patients will complet a course of 10 daily rTMS sessions. After receiving a full explanation of the procedures, all subjects will sign a written informed consent statement approved by the Helsinki Ethics Committee of Ben-Gurion University. Study Design The study suggested here will recruit 40 patients with DSM-IV PTSD also demonstrating at least moderately severe flashbacks. Each of the subjects will be recruited randomly to one of 4 groups:

  1. 1.Right DLPF Rtms (10Hz) co-administered with neutral visual and/or auditori stimuli;
  2. 2.Right DLPF Rtms (10Hz) co-administered with visual and/or auditori traumatic stimuli mimicking experiences appearing during the patients flashbacks;
  3. 3.Left DLPF Rtms (10Hz) co-administered with neutral visual and or auditori stimuli;
  4. 4.Left DLPF Rtms (10Hz) co-administered with visual and/or auditori traumatic stimuli mimicking experiences appearing during the patients flashbacks;

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2008

Typical duration for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 8, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

4.3 years

First QC Date

June 28, 2010

Last Update Submit

February 5, 2013

Conditions

FlashbacksPosttraumatic Stress Disorder

Keywords

PTSDFLASHBACKSTMSEXPOSURE

Outcome Measures

Primary Outcomes (1)

  • flashback severity, CAPS score

    the study will be held for 1-2 years

Study Arms (4)

TMS TO RT DLPF WITH EXPOSURE

ACTIVE COMPARATOR

TMS TO RIGHT PREFRONTAL DORSOLATERAL BRAIN AREA WITH EXPOSURE

Device: rapid TMS, EXPOSURE TO TRAUMATIC STIMULIDevice: rapid TMS, EXPOSURE

TMS TO RIGHT DLPF BRAIN AREA WITHOUT EXPOSURE

ACTIVE COMPARATOR

TMS TO RIGHT DLPF BRAIN AREA WITHOUT EXPOSURE

Device: rapid TMS, EXPOSURE TO TRAUMATIC STIMULIDevice: rapid TMS, EXPOSURE

TMS TO LEFT PREFRONTAL DORSOLATERAL BRAIN AREA WITH EXPOSURE

ACTIVE COMPARATOR

TMS TO LEFT PREFRONTAL DORSOLATERAL BRAIN AREA WITH EXPOSURE

Device: rapid TMS, EXPOSURE TO TRAUMATIC STIMULIDevice: rapid TMS, EXPOSURE

TMS TO LEFT DLPF BRAIN AREA WITHOUT EXPOSURE

ACTIVE COMPARATOR

TMS TO LEFT DLPF BRAIN AREA WITHOUT EXPOSURE

Device: rapid TMS, EXPOSURE TO TRAUMATIC STIMULIDevice: rapid TMS, EXPOSURE

Interventions

rapid TMS, EXPOSURE TO TRAUMATIC STIMULIDEVICE

RAPID TMS, EXPOSURE TO TRAUMATIC STIMULI

TMS TO LEFT DLPF BRAIN AREA WITHOUT EXPOSURETMS TO LEFT PREFRONTAL DORSOLATERAL BRAIN AREA WITH EXPOSURETMS TO RIGHT DLPF BRAIN AREA WITHOUT EXPOSURETMS TO RT DLPF WITH EXPOSURE
rapid TMS, EXPOSUREDEVICE

apid TMS, EXPOSURE

TMS TO LEFT DLPF BRAIN AREA WITHOUT EXPOSURETMS TO LEFT PREFRONTAL DORSOLATERAL BRAIN AREA WITH EXPOSURETMS TO RIGHT DLPF BRAIN AREA WITHOUT EXPOSURETMS TO RT DLPF WITH EXPOSURE

Eligibility Criteria

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

You may qualify if:

  • Consecutive patients fulfilling the DSM-IV diagnostic criteria for PTSD (as assessed by the Structured Clinical Interview) will be recruited from the inpatient and outpatient treatment programs at the Beer Sheva Mental Health Center.

You may not qualify if:

  • Subjects
  • substance use disorder, cardiac pacemaker implant, or a history of epilepsy, neurosurgery, or brain trauma.
  • Patients suffering from chronic medical conditions of any sort will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beersheva mental Health Center

Beersheva,, Israel

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Joseph Levine, Associate Professor

    Beersheva mental Health Center, Israel

    PRINCIPAL INVESTIGATOR

  • Nimrod Grisaru

    Beersheva Mental Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, psychiatrist

Study Record Dates

First Submitted

June 28, 2010

First Posted

September 8, 2010

Study Start

November 1, 2008

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

February 7, 2013

Record last verified: 2013-02

Locations

IL(1)