Post-Traumatic Stress DisorderNCT00685152
High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Post-traumatic Stress Disorder (PTSD)
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic) in people with Post-Traumatic Stress Disorder, run by Queen's University at 2 sites in 2 countries.
Trial summary
This is a double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of high-frequency (20Hz) rTMS applied to the right dorsolateral prefrontal cortex for 6 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2008to Nov 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Patient Information and Consent.
- Patients with primary Post-Traumatic Stress Disorder (as diagnosed by MINI) and DSM IV TR.
- Patients with CAPS score of at least 40.
- Males or females between 18-65 years of age.
- Patients not taking PTSD pharmacotherapy for at least last 2 weeks prior to commencing in the study or if they are taking PTSD pharmacotherapy it must be stable for at least 6 weeks prior to the start and not be changed during the 6 weeks of the study treatment phase.
- Individual or group supportive psychotherapy may continue during the study but will not be allowed to start new psychotherapy during the 6 weeks of the study treatment phase.
Who cannot join
- Current primary Axis I disorder including Schizophrenia, Bipolar Disorder type I, Major Depressive Disorder.
- Other primary Axis I disorders which, in the opinion of the investigator, may affect the outcome of this study.
- Patients with HDRS score ≥ 18.
- A metallic implant in cranium (except the mouth).
- Patients with severe or unstable medical conditions, which in the opinion of the investigator would interfere with their progress or safety.
- ECT treatment within the last three months.
Show all 10Show fewer
- Patients with a history of epilepsy.
- Patients with neurological disorder leading to increased intracranial pressure.
- Patients with severe cardiac disorder or intracardiac lines and pacemakers.
- Patients with current suicide risk ≥ 6 points by MINI.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
This is a double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of high-frequency (20Hz) rTMS applied to the right dorsolateral prefrontal cortex for 6 weeks. The primary objective is to evaluate the change in PTSD symptoms before and after six weeks of high-frequency rTMS treatment as measured by the Clinician Administered PTSD Scale (CAPS) in both active and control groups.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)
- 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.
Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)Device
Also called rTMS machine (MagPro, Medtronic).
6 weeks of either Active or Sham Repetitive Transcranial Magnetic Stimulation (rTMS). Active treatment comprises of stimulation with rTMS frequency 20Hz, intensity 110% of Motor Threshold, 20 trains, 9 seconds per train, 51 seconds of intertrain interval that is applied over the Right Dorsolateral Prefrontal Cortex by a figure eight shaped coil. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6. Sham treatment will mimic active treatment; The rTMS machine used is MagPro and the company name is Medtronic.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS | Experimental | Repetitive Transcranial Magnetic Stimulation Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic) |
| 2 | Sham comparator | Device: Sham (placebo) Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale (CAPS) in both active and sham groups
Measured: pre, week 2,4,6,8 & 12
Secondary outcomes (7)
Treatment Outcome PTSD scale (TOP-8)
Measured: Pre, week 2,4,6,8 & 12
Hamilton Anxiety Scale
Measured: Pre, week 2,4,6,8 & 12
Hamilton Depression Rating Scale
Measured: Pre, week 2,4,6,8 & 12
Clinical Global Impression Scale (both severity and improvement)
Measured: Pre, week 2,4,6,8 & 12
Social Functioning-36 Quality of Life Scale version(1)
Measured: Pre, week 2,4,6,8 & 12
Pittsburgh Sleep Quality Index
Measured: Pre, week 2,4,6,8 & 12
PTSD Checklist-civilian (PCL-C)
Measured: Pre, week 2,4,6,8 & 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startJan 2008
- Primary completionNov 2012
- Study completionNov 2012
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Roumen Milev, Queen's University
- Investigators
- Roumen Milev, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685152
- Sponsor's protocol ID
- psiy-267-07
- Status last verified
- Dec 2015
- First submitted
- 8 May 2008
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Post-traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT00685152
- Acronym / sponsor ID
- psiy-267-07
- Conditions
- Post-Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 28 May 2008 (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.
This is a double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of high-frequency (20Hz) rTMS applied to the right dorsolateral prefrontal cortex for 6 weeks. The primary objective is to evaluate the change in PTSD symptoms before and after six weeks of high-frequency rTMS treatment as measured by the Clinician Administered PTSD Scale (CAPS) in both active and control groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)Repetitive Transcranial Magnetic Stimulation |
| 2 | Sham comparator | Device: Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)Device: Sham (placebo) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed Patient Information and Consent.
- Patients with primary Post-Traumatic Stress Disorder (as diagnosed by MINI) and DSM IV TR.
- Patients with CAPS score of at least 40.
- Males or females between 18-65 years of age.
- Patients not taking PTSD pharmacotherapy for at least last 2 weeks prior to commencing in the study or if they are taking PTSD pharmacotherapy it must be stable for at least 6 weeks prior to the start and not be changed during the 6 weeks of the study treatment phase.
Key exclusion criteria (10 listed)
- Current primary Axis I disorder including Schizophrenia, Bipolar Disorder type I, Major Depressive Disorder.
- Other primary Axis I disorders which, in the opinion of the investigator, may affect the outcome of this study.
- Patients with HDRS score ≥ 18.
- A metallic implant in cranium (except the mouth).
- Patients with severe or unstable medical conditions, which in the opinion of the investigator would interfere with their progress or safety.
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)Also: rTMS machine (MagPro, Medtronic).6 weeks of either Active or Sham Repetitive Transcranial Magnetic Stimulation (rTMS). Active treatment comprises of stimulation with rTMS frequency 20Hz, intensity 110% of Motor Threshold, 20 trains, 9 seconds per train, 51 seconds of intertrain interval that is applied over the Right Dorsolateral Prefrontal Cortex by a figure eight shaped coil. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6. Sham treatment will mimic active treatment; The rTMS machine used is MagPro and the company name is Medtronic. | Device | 2, Active rTMS |
Primary outcome
Clinician Administered PTSD Scale (CAPS) in both active and sham groups
Time frame: pre, week 2,4,6,8 & 12
7 secondary outcomes
Treatment Outcome PTSD scale (TOP-8)
Time frame: Pre, week 2,4,6,8 & 12
Hamilton Anxiety Scale
Time frame: Pre, week 2,4,6,8 & 12
Hamilton Depression Rating Scale
Time frame: Pre, week 2,4,6,8 & 12
Clinical Global Impression Scale (both severity and improvement)
Time frame: Pre, week 2,4,6,8 & 12
Social Functioning-36 Quality of Life Scale version(1)
Time frame: Pre, week 2,4,6,8 & 12
Pittsburgh Sleep Quality Index
Time frame: Pre, week 2,4,6,8 & 12
PTSD Checklist-civilian (PCL-C)
Time frame: Pre, week 2,4,6,8 & 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 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.
Roumen Milev, MD principal investigator
Queen's University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic) in people with Post-Traumatic Stress Disorder, run by Queen's University at 2 sites in 2 countries.
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 6 inclusion and 10 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: finished, as of the sponsor's last update on 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bulgaria, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD Scale (CAPS) in both active and sham groups (time frame: pre, week 2,4,6,8 & 12). 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 16 Dec 2015.