High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in PTSD (rTMS)

Naval Medical Center

Status and phase: Completed; Early Phase 1

Conditions: PTSD, Post Traumatic Stress Disorder

Treatments: Other: 20 Hz rTMS of the right dorsolateral prefrontal cortex; Other: 10 Hz rTMS of the right dorsolateral prefrontal cortex

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02873299

NMCSD.2011.0025

Details and patient eligibility

About

The purpose of this study is to compare two slightly different methods of transcranial magnetic stimulation (TMS) to treat Post Traumatic Stress Disorder (PTSD)

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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37 participants in 3 patient groups

Treatment as usual

No Intervention group

Description:

Treatment as usual, wait list control group

rTMS at 10Hz

Active Comparator group

Description:

10 Hz rTMS of the right dorsolateral prefrontal cortex

Treatment:

Other: 10 Hz rTMS of the right dorsolateral prefrontal cortex

rTMS at 20Hz

Active Comparator group

Description:

20 Hz rTMS of the right dorsolateral prefrontal cortex

Treatment:

Other: 20 Hz rTMS of the right dorsolateral prefrontal cortex