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Low -vs- High-Frequency Repetitive TMS of the Right Dorsolateral Prefrontal Cortex in PTSD

Low-Frequency Versus High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in Posttraumatic Stress Disorder

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02369614
Enrollment
30
Registered
2015-02-24
Start date
2014-08-31
Completion date
2019-03-31
Last updated
2019-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD - Post Traumatic Stress Disorder

Keywords

rTMS - repetitive transcranial magnetic stimulation, CAPS - Clinician Administered PTSD Scale

Brief 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.

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. 1 Hz rTMS of the right dorsolateral prefrontal cortex 2. 10 Hz rTMS of the right dorsolateral prefrontal cortex 3. Sham rTMS of the right dorsolateral prefrontal cortex 4. OASIS treatment as usual Treatment will be administered in 10 daily sessions, conducted on weekdays, for 2 consecutive weeks. .

Interventions

OTHERActive Comparator: 1 Hz rTMS

1 Hz rTMS

OTHERActive Comparator: 10 Hz rTMS

10 Hz rTMS

OTHERSham Comparator:

Sham rTMS

Sponsors

United States Naval Medical Center, San Diego
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in Clinician Administered PSTD Scale (CAPS) score from Baseline to week 4Baseline and Week 4Clinician Administered PSTD Scale (CAPS)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026