The Use of Noninvasive Brain Stimulation in Post-traumatic Stress Disorder

September 3, 2015 updated by: Laval University
The purpose of this trial is to study the effect of noninvasive brain stimulation in adults with post-traumatic stress disorder.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of this trial is to study the effect of noninvasive brain stimulation on symptoms severity in adults with post-traumatic stress disorder.

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
      • Quebec, Canada
        • Recruiting
        • IRDPQ
        • Contact:
          • Jean Levasseur-Moreau
          • Phone Number: 418-529-9141

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-60 years old

Exclusion Criteria:

  • Transcranial magnetic stimulation ineligibility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active transcranial magnetic stimulation
Active transcranial magnetic stimulation will induce real pulses using the transcranial magnetic stimulation device.
Device: Active repetitive Transcranial Magnetic Stimulation
Active transcranial magnetic stimulation will induce real pulses using the transcranial magnetic stimulation device.
Sham Comparator: Sham transcranial magnetic stimulation
Sham transcranial magnetic stimulation will not induce any pulses using the same transcranial magnetic stimulation device but by also adding a sham block device.
Device: Sham repetitive Transcranial Magnetic Stimulation
Sham transcranial magnetic stimulation will not induce any pulses using the same transcranial magnetic stimulation device but by also adding a sham block device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of symptoms on the following clinical scale: PTSD symptoms as assessed by the Modified PTSD Symptom Scale (MPSS-SR)
Time Frame: 2 months
Units will be the differences (%) in scores before and after the intervention
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of symptoms on the following clinical scale: anxiety symptoms as assessed by the Beck Anxiety Inventory (BAI)
Time Frame: 2 months
Units will be the differences (%) in scores before and after the intervention
2 months
Severity of symptoms on the following clinical scale: depression symptoms as assessed by the Beck Depression Inventory (BDI)
Time Frame: 2 months
Units will be the differences (%) in scores before and after the intervention
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

March 26, 2015

First Submitted That Met QC Criteria

September 3, 2015

First Posted (Estimate)

September 7, 2015

Study Record Updates

Last Update Posted (Estimate)

September 7, 2015

Last Update Submitted That Met QC Criteria

September 3, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-011
  • 2013-341 (Other Identifier: Institut de réadaptation en déficience physique de Québec)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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