The Use of Noninvasive Brain Stimulation in Post-traumatic Stress Disorder
2 other identifiers
interventional
28
1 country
1
Brief Summary
The purpose of this trial is to study the effect of noninvasive brain stimulation in adults with post-traumatic stress disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2015
1 active site
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
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 26, 2015
CompletedFirst Posted
Study publicly available on registry
September 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedSeptember 7, 2015
September 1, 2015
1 year
March 26, 2015
September 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Severity of symptoms on the following clinical scale: anxiety symptoms as assessed by the Beck Anxiety Inventory (BAI)
2 months
Severity of symptoms on the following clinical scale: depression symptoms as assessed by the Beck Depression Inventory (BDI)
2 months
Study Arms (2)
Active transcranial magnetic stimulation
ACTIVE COMPARATORActive transcranial magnetic stimulation will induce real pulses using the transcranial magnetic stimulation device.
Sham transcranial magnetic stimulation
SHAM COMPARATORSham transcranial magnetic stimulation will not induce any pulses using the same transcranial magnetic stimulation device but by also adding a sham block device.
Interventions
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.
Eligibility Criteria
You may qualify if:
- years old
You may not qualify if:
- Transcranial magnetic stimulation ineligibility
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laval Universitylead
Study Sites (1)
IRDPQ
Québec, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2015
First Posted
September 7, 2015
Study Start
March 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
September 7, 2015
Record last verified: 2015-09