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

PTSD - Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02369614
• Other study ID #: NMCSD.2014.0061
• Status: Terminated
• Phase: N/A
• Start date: August 2014
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: United States Naval Medical Center, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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. .

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• PTSD - Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Active Comparator: 1 Hz rTMS
1 Hz rTMS
• Active Comparator: 10 Hz rTMS
10 Hz rTMS
• Sham Comparator:
Sham rTMS

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinician Administered PSTD Scale (CAPS) score from Baseline to week 4	Clinician Administered PSTD Scale (CAPS)	Baseline and Week 4