Post-traumatic Stress DisorderNCT02542709
The Use of Noninvasive Brain Stimulation in Post-traumatic Stress Disorder
A study testing Active repetitive Transcranial Magnetic Stimulation in people with Post-traumatic Stress Disorder, run by Laval University at 1 site in Canada.
Trial summary
The purpose of this trial is to study the effect of noninvasive brain stimulation in adults with post-traumatic stress disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Active repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-60 years old
Who cannot join
- Transcranial magnetic stimulation ineligibility
Trial locations and contacts
1 site in 1 country.
Jean Levasseur-Moreau contact
Canada1 site, 1 recruiting
- Recruiting
IRDPQ
Québec
Jean Levasseur-Moreau, 418-529-9141
About this study
The purpose of this trial is to study the effect of noninvasive brain stimulation in adults with post-traumatic stress disorder.
Read the 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.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- Active repetitive Transcranial Magnetic Stimulation, Sham repetitive Transcranial Magnetic Stimulation
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active repetitive Transcranial Magnetic StimulationDevice
Active transcranial magnetic stimulation will induce real pulses using the transcranial magnetic stimulation device.
Sham repetitive Transcranial Magnetic StimulationDevice
Sham transcranial magnetic stimulation will not induce any pulses using the same transcranial magnetic stimulation device but by also adding a sham block device.
| Study group | Role | What they receive |
|---|---|---|
| Active transcranial magnetic stimulation | Active comparator | Active transcranial magnetic stimulation will induce real pulses using the transcranial magnetic stimulation device. Receives: Device: Active repetitive Transcranial Magnetic Stimulation |
| Sham transcranial magnetic stimulation | Sham comparator | Sham transcranial magnetic stimulation will not induce any pulses using the same transcranial magnetic stimulation device but by also adding a sham block device. Receives: Device: Sham repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months
Secondary outcomes (2)
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
Measured: 2 months
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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542709
- Sponsor's protocol ID
- 2013-011
- Other IDs
- 2013-341
- Status last verified
- Sep 2015
- First submitted
- 26 Mar 2015
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Noninvasive Brain Stimulation in Post-traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT02542709
- Acronym / sponsor ID
- 2013-011
- Conditions
- Post-traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active transcranial magnetic stimulation | Active comparator | Device: Active repetitive Transcranial Magnetic StimulationActive transcranial magnetic stimulation will induce real pulses using the transcranial magnetic stimulation device. |
| Sham transcranial magnetic stimulation | Sham comparator | Device: Sham repetitive Transcranial Magnetic StimulationSham transcranial magnetic stimulation will not induce any pulses using the same transcranial magnetic stimulation device but by also adding a sham block device. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-60 years old
Key exclusion criteria (1 listed)
- Transcranial magnetic stimulation ineligibility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active repetitive Transcranial Magnetic StimulationActive transcranial magnetic stimulation will induce real pulses using the transcranial magnetic stimulation device. | Device | Active transcranial magnetic stimulation |
| Sham repetitive Transcranial Magnetic StimulationSham 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 transcranial magnetic stimulation |
Primary outcome
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 secondary outcomes
Severity of symptoms on the following clinical scale: anxiety symptoms as assessed by the Beck Anxiety Inventory (BAI)
Time frame: 2 months
Severity of symptoms on the following clinical scale: depression symptoms as assessed by the Beck Depression Inventory (BDI)
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Levasseur-Moreau contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active repetitive Transcranial Magnetic Stimulation in people with Post-traumatic Stress Disorder, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean Levasseur-Moreau (jean.levasseur-moreau.1@ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of symptoms on the following clinical scale: PTSD symptoms as assessed by the Modified PTSD Symptom Scale (MPSS-SR) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2015.