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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2019-03-31

Brief Summary

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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.

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Detailed Description

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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. .

Conditions

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PTSD - Post Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active Comparator:1 Hz rTMS

Active Comparator: 1 Hz rTMS

Group Type ACTIVE_COMPARATOR

Active Comparator: 1 Hz rTMS

Intervention Type OTHER

1 Hz rTMS

Active Comparator:10 Hz rTMS

Group Type ACTIVE_COMPARATOR

Active Comparator: 10 Hz rTMS

Intervention Type OTHER

10 Hz rTMS

Sham Comparator:Sham rTMS

Sham Comparator: Sham rTMS

Group Type SHAM_COMPARATOR

Sham Comparator:

Intervention Type OTHER

Sham rTMS

OASIS treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Active Comparator: 1 Hz rTMS

1 Hz rTMS

Intervention Type OTHER

Active Comparator: 10 Hz rTMS

10 Hz rTMS

Intervention Type OTHER

Sham Comparator:

Sham rTMS

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No