PTSD, Post Traumatic Stress DisorderEarly Phase 1rTMSNCT02873299
High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in PTSD
A Early Phase 1 study testing 10 Hz rTMS of the right dorsolateral prefrontal cortex and 20 Hz rTMS of the right dorsolateral prefrontal cortex in people with PTSD, Post Traumatic Stress Disorder, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial summary
The purpose of this study is to compare two slightly different methods of transcranial magnetic stimulation (TMS) to treat Post Traumatic Stress Disorder (PTSD) Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD, Post Traumatic Stress Disorder
- What is being tested?
- 10 Hz rTMS of the right dorsolateral prefrontal cortex and 20 Hz rTMS of the right dorsolateral prefrontal cortex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Oct 2014
- Phase
- Early Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to give informed consent
- Diagnosis of Post-Traumatic Stress Disorder as determined by the SCID
- CAPS score of at least 40
- Males or females between 18-65 years of age
- Willing to give up new psychotherapy or changes in psychiatric medications during the course of the TMS treatment.
Who cannot join
- Current primary Axis I disorder including Schizophrenia, Bipolar Disorder type I, Major Depressive Disorder
- 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
- Patients with a history of epilepsy
Show all 10Show fewer
- Patients with neurological disorder leading to increased intracranial pressure
- Participation in a new course of psychotherapy during the 24 days of the study
- A new psychiatric medication within 6 weeks of enrolling in the study
- Changes in psychiatric medication within 2 weeks of starting the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in Post Traumatic Stress Disorder
The purpose of this study is to compare two slightly different methods of transcranial magnetic stimulation (TMS) to treat Post Traumatic Stress Disorder (PTSD)
Read the detailed description
This is a randomized single-blind pilot study investigating the efficacy of high-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the right dorsolateral prefrontal cortex at either 10 Hz or 20 Hz as compared to a treatment as usual group for the treatment of Post Traumatic Stress Disorder (PTSD) symptoms.
- Conditions
- PTSD, Post Traumatic Stress Disorder
- Being tested
- 10 Hz rTMS of the right dorsolateral prefrontal cortex, 20 Hz rTMS of the right dorsolateral prefrontal cortex
- Keywords
- PTSD, Post Traumatic Stress Disorder
- Medical subject headings
- Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 Hz rTMS of the right dorsolateral prefrontal cortexOther
Ten sessions of 10 Hz rTMS of the right dorsolateral prefrontal cortex
20 Hz rTMS of the right dorsolateral prefrontal cortexOther
Ten sessions of 20 Hz rTMS of the right dorsolateral prefrontal cortex
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | No intervention | Treatment as usual, wait list control group |
| rTMS at 10Hz | Active comparator | 10 Hz rTMS of the right dorsolateral prefrontal cortex Receives: Other: 10 Hz rTMS of the right dorsolateral prefrontal cortex |
| rTMS at 20Hz | Active comparator | 20 Hz rTMS of the right dorsolateral prefrontal cortex Receives: Other: 20 Hz rTMS of the right dorsolateral prefrontal cortex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale , CAPS
The CAPS is the gold-standard, semi-structured interview that corresponds to DSM-IV criteria for PTSD.
Measured: day 10
Secondary outcomes (1)
Posttraumatic Stress Disorder Checklist, PCL
The PCL consists of 17 items measured on a 5-point Likert scale ranging from "not at all" to "extremely
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startApr 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD, 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Marc A Capobianco, MD, DFAPA, Principal investigator, NMCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873299
- Sponsor's protocol ID
- NMCSD.2011.0025
- Acronym
- rTMS
- Status last verified
- Aug 2016
- First submitted
- 30 Sep 2014
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in Post Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT02873299
- Acronym / sponsor ID
- rTMS / NMCSD.2011.0025
- Conditions
- PTSD, Post Traumatic Stress Disorder
- Keywords
- PTSD, Post Traumatic Stress Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- Apr 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 19 Aug 2016 (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 study is to compare two slightly different methods of transcranial magnetic stimulation (TMS) to treat Post Traumatic Stress Disorder (PTSD)
Detailed description
This is a randomized single-blind pilot study investigating the efficacy of high-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the right dorsolateral prefrontal cortex at either 10 Hz or 20 Hz as compared to a treatment as usual group for the treatment of Post Traumatic Stress Disorder (PTSD) symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | No intervention | –Treatment as usual, wait list control group |
| rTMS at 10Hz | Active comparator | Other: 10 Hz rTMS of the right dorsolateral prefrontal cortex10 Hz rTMS of the right dorsolateral prefrontal cortex |
| rTMS at 20Hz | Active comparator | Other: 20 Hz rTMS of the right dorsolateral prefrontal cortex20 Hz rTMS of the right dorsolateral prefrontal cortex |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willing and able to give informed consent
- Diagnosis of Post-Traumatic Stress Disorder as determined by the SCID
- CAPS score of at least 40
- Males or females between 18-65 years of age
- Willing to give up new psychotherapy or changes in psychiatric medications during the course of the TMS treatment.
Key exclusion criteria (10 listed)
- Current primary Axis I disorder including Schizophrenia, Bipolar Disorder type I, Major Depressive Disorder
- 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
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 |
|---|---|---|
| 10 Hz rTMS of the right dorsolateral prefrontal cortexTen sessions of 10 Hz rTMS of the right dorsolateral prefrontal cortex | Other | rTMS at 10Hz |
| 20 Hz rTMS of the right dorsolateral prefrontal cortexTen sessions of 20 Hz rTMS of the right dorsolateral prefrontal cortex | Other | rTMS at 20Hz |
Primary outcome
Clinician Administered PTSD Scale , CAPS
Time frame: day 10
The CAPS is the gold-standard, semi-structured interview that corresponds to DSM-IV criteria for PTSD.
1 secondary outcome
Posttraumatic Stress Disorder Checklist, PCL
Time frame: week 24
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 22 Aug 2016.
- Individual participant dataSharing planned: No
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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.
Marc A Capobianco, MD, DFAPA principal investigator
NMCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 10 Hz rTMS of the right dorsolateral prefrontal cortex and 20 Hz rTMS of the right dorsolateral prefrontal cortex in people with PTSD, Post Traumatic Stress Disorder, run by United States Naval Medical Center, San Diego at 1 site in United States.
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 5 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 22 Aug 2016. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (time frame: day 10). 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 22 Aug 2016.