Back to resultsThe Use of Noninvasive Brain Stimulation in Post-traumatic Stress Disorder
Primary Purpose
Post-traumatic Stress Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Active repetitive Transcranial Magnetic Stimulation
Sham repetitive Transcranial Magnetic Stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Post-traumatic Stress Disorder
Eligibility Criteria
Inclusion Criteria:
- 18-60 years old
Exclusion Criteria:
- Transcranial magnetic stimulation ineligibility
Sites / Locations
- IRDPQRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active transcranial magnetic stimulation
Sham transcranial magnetic stimulation
Arm Description
Active transcranial magnetic stimulation will induce real pulses using the transcranial magnetic stimulation device.
Sham transcranial magnetic stimulation will not induce any pulses using the same transcranial magnetic stimulation device but by also adding a sham block device.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02542709
Brief Title
The Use of Noninvasive Brain Stimulation in Post-traumatic Stress Disorder
Official Title
The Use of Noninvasive Brain Stimulation in Post-traumatic Stress Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laval University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this trial is to study the effect of noninvasive brain stimulation in adults with post-traumatic stress disorder.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active transcranial magnetic stimulation
Arm Type
Active Comparator
Arm Description
Active transcranial magnetic stimulation will induce real pulses using the transcranial magnetic stimulation device.
Arm Title
Sham transcranial magnetic stimulation
Arm Type
Sham Comparator
Arm Description
Sham transcranial magnetic stimulation will not induce any pulses using the same transcranial magnetic stimulation device but by also adding a sham block device.
Intervention Type
Device
Intervention Name(s)
Active repetitive Transcranial Magnetic Stimulation
Intervention Description
Active transcranial magnetic stimulation will induce real pulses using the transcranial magnetic stimulation device.
Intervention Type
Device
Intervention Name(s)
Sham repetitive Transcranial Magnetic Stimulation
Intervention Description
Sham transcranial magnetic stimulation will not induce any pulses using the same transcranial magnetic stimulation device but by also adding a sham block device.
Primary Outcome Measure Information:
Title
Severity of symptoms on the following clinical scale: PTSD symptoms as assessed by the Modified PTSD Symptom Scale (MPSS-SR)
Description
Units will be the differences (%) in scores before and after the intervention
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Severity of symptoms on the following clinical scale: anxiety symptoms as assessed by the Beck Anxiety Inventory (BAI)
Description
Units will be the differences (%) in scores before and after the intervention
Time Frame
2 months
Title
Severity of symptoms on the following clinical scale: depression symptoms as assessed by the Beck Depression Inventory (BDI)
Description
Units will be the differences (%) in scores before and after the intervention
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18-60 years old
Exclusion Criteria:
Transcranial magnetic stimulation ineligibility
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Levasseur-Moreau
Email
jean.levasseur-moreau.1@ulaval.ca
Facility Information:
Facility Name
IRDPQ
City
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Levasseur-Moreau
Phone
418-529-9141
12. IPD Sharing Statement
Learn more about this trial
The Use of Noninvasive Brain Stimulation in Post-traumatic Stress Disorder
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