PTSD - Post Traumatic Stress DisorderNCT02369614
Low -vs- High-Frequency Repetitive TMS of the Right Dorsolateral Prefrontal Cortex in PTSD
A study testing Active Comparator: 1 Hz rTMS and Active Comparator: 10 Hz rTMS in people with PTSD - Post Traumatic Stress Disorder, run by United States Naval Medical Center, San Diego.
Trial summary
This is a randomized placebo/sham controlled, double-blind study investigating the efficacy of high- and low-frequency rTMS applied to the right DLPFC at either 1 Hz, 10 Hz, or sham rTMS as compared to an OASIS treatment as usual group for the treatment of PTSD symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder
- What is being tested?
- Active Comparator: 1 Hz rTMS and Active Comparator: 10 Hz rTMS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Mar 2019
- 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
- Participant in the OASIS program
- Willing and able to give informed consent
- Diagnosis of Post-Traumatic Stress Disorder as determined by the CAPS CAPS score of at least 50
- Males or females between 18-65 years of age
Who cannot join
- Current primary Axis I disorder including Schizophrenia, Bipolar Disorder type I, Active Substance use
- 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 30 days Patients with neurological disorder leading to increased intracranial pressure
- Participation in other interventional treatment protocols (participants of monitoring/observational studies can be included)
About this study
Official title: Low-Frequency Versus High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in Posttraumatic Stress Disorder
This is a randomized placebo/sham controlled, double-blind study investigating the efficacy of high- and low-frequency rTMS applied to the right DLPFC at either 1 Hz, 10 Hz, or sham rTMS as compared to an OASIS treatment as usual group for the treatment of PTSD symptoms.
Read the detailed description
The study will be carried out within the Overcoming Adversity and Stress Injury Support (OASIS) program administered by Naval Medical Center San Diego (NMSD). OASIS is a residential treatment program developed for active duty service members diagnosed with combat related PTSD. OASIS is a 9 week program in which cohorts of 10 patients undergo a variety of therapeutic activities with a focus on cognitive processing therapy (CPT) of combat trauma conducted in both group and individual formats.
Subjects who qualify will be assigned by block randomization to one of four arms:
- 1 Hz rTMS of the right dorsolateral prefrontal cortex
- 10 Hz rTMS of the right dorsolateral prefrontal cortex
- Sham rTMS of the right dorsolateral prefrontal cortex
- OASIS treatment as usual
Treatment will be administered in 10 daily sessions, conducted on weekdays, for 2 consecutive weeks. .
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Being tested
- Active Comparator: 1 Hz rTMS, Active Comparator: 10 Hz rTMS, Sham Comparator:
- Keywords
- rTMS - repetitive transcranial magnetic stimulation, CAPS - Clinician Administered PTSD Scale
- Medical subject headings
- Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: 1 Hz rTMSOther
1 Hz rTMS
Active Comparator: 10 Hz rTMSOther
10 Hz rTMS
Sham Comparator:Other
Sham rTMS
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator:1 Hz rTMS | Active comparator | Active Comparator: 1 Hz rTMS Receives: Other: Active Comparator: 1 Hz rTMS |
| Active Comparator:10 Hz rTMS | Active comparator | Active Comparator:10 Hz rTMS Receives: Other: Active Comparator: 10 Hz rTMS |
| Sham Comparator:Sham rTMS | Sham comparator | Sham Comparator: Sham rTMS Receives: Other: Sham Comparator: |
| OASIS treatment as usual | No intervention | OASIS treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinician Administered PSTD Scale (CAPS) score from Baseline to week 4
Clinician Administered PSTD Scale (CAPS)
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startAug 2014
- Primary completionMar 2019
- Study completionMar 2019
Why it stopped: Staffing issues
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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Donald Hurst, United States Naval Medical Center, San Diego
- Investigators
- Donald Hurst, MD, Principal investigator, NMCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369614
- Sponsor's protocol ID
- NMCSD.2014.0061
- Status last verified
- Mar 2019
- First submitted
- 17 Nov 2014
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Frequency Versus High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT02369614
- Acronym / sponsor ID
- NMCSD.2014.0061
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Keywords
- rTMS - repetitive transcranial magnetic stimulation, CAPS - Clinician Administered PTSD Scale
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Staffing issues
- Enrolment
- 30 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- Aug 2014
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 24 Feb 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.
This is a randomized placebo/sham controlled, double-blind study investigating the efficacy of high- and low-frequency rTMS applied to the right DLPFC at either 1 Hz, 10 Hz, or sham rTMS as compared to an OASIS treatment as usual group for the treatment of PTSD symptoms.
Detailed description
The study will be carried out within the Overcoming Adversity and Stress Injury Support (OASIS) program administered by Naval Medical Center San Diego (NMSD). OASIS is a residential treatment program developed for active duty service members diagnosed with combat related PTSD. OASIS is a 9 week program in which cohorts of 10 patients undergo a variety of therapeutic activities with a focus on cognitive processing therapy (CPT) of combat trauma conducted in both group and individual formats.
Subjects who qualify will be assigned by block randomization to one of four arms:
- 1 Hz rTMS of the right dorsolateral prefrontal cortex
- 10 Hz rTMS of the right dorsolateral prefrontal cortex
- Sham rTMS of the right dorsolateral prefrontal cortex
- OASIS treatment as usual
Treatment will be administered in 10 daily sessions, conducted on weekdays, for 2 consecutive weeks. .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Comparator:1 Hz rTMS | Active comparator | Other: Active Comparator: 1 Hz rTMSActive Comparator: 1 Hz rTMS |
| Active Comparator:10 Hz rTMS | Active comparator | Other: Active Comparator: 10 Hz rTMSActive Comparator:10 Hz rTMS |
| Sham Comparator:Sham rTMS | Sham comparator | Other: Sham Comparator:Sham Comparator: Sham rTMS |
| OASIS treatment as usual | No intervention | –OASIS treatment as usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant in the OASIS program
- Willing and able to give informed consent
- Diagnosis of Post-Traumatic Stress Disorder as determined by the CAPS CAPS score of at least 50
- Males or females between 18-65 years of age
Key exclusion criteria (4 listed)
- Current primary Axis I disorder including Schizophrenia, Bipolar Disorder type I, Active Substance use
- 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 30 days Patients with neurological disorder leading to increased intracranial pressure
- Participation in other interventional treatment protocols (participants of monitoring/observational studies can be included)
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 Comparator: 1 Hz rTMS1 Hz rTMS | Other | Active Comparator:1 Hz rTMS |
| Active Comparator: 10 Hz rTMS10 Hz rTMS | Other | Active Comparator:10 Hz rTMS |
| Sham Comparator:Sham rTMS | Other | Sham Comparator:Sham rTMS |
Primary outcome
Change in Clinician Administered PSTD Scale (CAPS) score from Baseline to week 4
Time frame: Baseline and Week 4
Clinician Administered PSTD Scale (CAPS)
Results and safety
The study was stopped early (reason given: Staffing issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- 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.
Donald Hurst, MD principal investigator
NMCSD
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator: 1 Hz rTMS and Active Comparator: 10 Hz rTMS in people with PTSD - Post Traumatic Stress Disorder, run by United States Naval Medical Center, San Diego.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Staffing issues). Results are not available in the source record.
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?
Change in Clinician Administered PSTD Scale (CAPS) score from Baseline to week 4 (time frame: Baseline and Week 4). 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 14 Mar 2019.