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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02542709
Other study ID # 2013-011
Secondary ID 2013-341
Status Recruiting
Phase N/A
First received March 26, 2015
Last updated September 3, 2015
Start date March 2015
Est. completion date March 2016

Study information

Verified date September 2015
Source Laval University
Contact Jean Levasseur-Moreau
Email jean.levasseur-moreau.1@ulaval.ca
Is FDA regulated No
Health authority Canada: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- 18-60 years old

Exclusion Criteria:

- Transcranial magnetic stimulation ineligibility

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Intervention

Device:
Active repetitive Transcranial Magnetic Stimulation
Active transcranial magnetic stimulation will induce real pulses using the transcranial magnetic stimulation 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.

Locations

Country Name City State
Canada IRDPQ Quebec

Sponsors (1)

Lead Sponsor Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Severity of symptoms on the following clinical scale: PTSD symptoms as assessed by the Modified PTSD Symptom Scale (MPSS-SR) Units will be the differences (%) in scores before and after the intervention 2 months Yes
Secondary Severity of symptoms on the following clinical scale: anxiety symptoms as assessed by the Beck Anxiety Inventory (BAI) Units will be the differences (%) in scores before and after the intervention 2 months Yes
Secondary Severity of symptoms on the following clinical scale: depression symptoms as assessed by the Beck Depression Inventory (BDI) Units will be the differences (%) in scores before and after the intervention 2 months Yes
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