rTMS in the Treatment of PTSD

University of British Columbia

Status: Completed

Conditions: Post-traumatic Stress Disorder (PTSD)

Treatments: Device: rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT01806168

V12-01578 (Other Identifier)

H12-01578

Details and patient eligibility

About

The purpose of this study is to assess the effects of repetitive transcranial magnetic stimulation (rTMS) in civilian patients with a confirmed diagnosis of post-traumatic stress disorder (PTSD). This research study will determine whether low-frequency (1 Hertz [Hz]) or high-frequency (10 Hz) rTMS over the right dorsolateral prefrontal cortex (DLPFC) has an effect on symptoms of PTSD compared to sham rTMS treatment.

Enrollment: 31 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary diagnosis of PTSD as determined by a structured interview using the Mini International Neuropsychiatric Interview (MINI)
• no change in psychotropic medications within 4 weeks before the start of rTMS
• age > 19 years and < 70 years
• competency to give informed consent

Exclusion criteria

• any non-fixed metal object or implant (including cochlear implants) in brain, skull, scalp, or neck within 30 cm of the magnetic rTMS coil
• implantable devices, including cardiac pacemakers and defibrillators
• other contraindications to rTMS, including history of seizures (except childhood febrile seizures) or recent and unexplained syncope, first-degree relative with a history of epilepsy, treatment with a medication known to substantially decrease the seizure threshold, or pregnancy
• psychiatric diagnoses of psychosis or psychotic disorder (including psychotic depression), bipolar type I disorder, or organic mental disorders
• substance abuse/dependence within the past 3 months
• active suicidal risk as judged by the clinician
• borderline or antisocial personality disorder
• acute medical illness, including cancer
• any significant central nervous system disorder, such as brain mass, stroke, etc.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

31 participants in 3 patient groups, including a placebo group

Low-frequency (1 Hz) rTMS

Active Comparator group

Description:

Low-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.

Treatment:

Device: rTMS

High-frequency (10 Hz) rTMS

Active Comparator group

Description:

High-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.

Treatment:

Device: rTMS

Sham rTMS

Placebo Comparator group

Description:

Sham stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.

Treatment:

Device: rTMS