Study Testing if Fast or Slow rTMS is Better for the Treatment of Posttraumatic Stress Disorder (PTSD)

Completed · Not applicable

Conditions studied: Posttraumatic Stress Disorder, Depression

In brief

Objectives: The primary objective is to test whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater improvement in function as measured by IPF score and PTSD symptoms as measured with CAPS score. The secondary objectives include: one, testing which treatment provides a significantly greater improvement in depressive symptoms as measured by change in QIDS score; two, testing whether depression impacts effectiveness of 1 Hz versus 10 Hz rTMS for PTSD symptoms; three, testing which treatment is better tolerated as measured by participant drop out and side effect profiles. Research Design: Randomized single-blind (raters) prospective clinical trial testing the effectiveness 1 Hz rTMS versus 10 Hz rTMS in veterans with PTSD. Methodology: Veterans 18-50 years of age suffering from PTSD with and without depressive symptoms will be recruited from the community as well as mental health clinics at James A. Haley Veterans Administration Hospital. Plan to enroll 50 to have an evaluable sample of approximately 20 in each group. Participants will be consented and undergo screening for safety and appropriateness to be in the trial. Those deemed eligible will be evaluated with clinical measures of function, PTSD, depression, pain, and neurobehavioral symptoms. Participants will be randomized in equal proportion (stratified by significant depression defined as MADRS greater than 19) to one of two active treatments: right prefrontal 1 Hz rTMS versus right prefrontal 10 Hz rTMS. Participants will undergo assessment for safety prior to each treatment. The treatments will be performed 5 days a week for 6 weeks with a 3-week taper consisting of 3 days per week, 2 days per week, and 1 day per week. Clinical evaluations will be performed at baseline, after every five treatments, at the end of treatment, and at 1 and 3 months post treatment. CAPS and IPF scores will be used to determine if there is a significant difference between 1 Hz and 10 Hz right prefrontal rTMS for PTSD symptoms and function respectively. The QIDS scores will be used to test for a significant difference in change in depressive symptoms for both the participants with significant depressive symptoms and the entire group. The number of dropouts (related specifically to side effects and all cause) will be used along with side effect profiles to test for differences in tolerability of the two treatments.

Key facts

Study ID

NCT02158663

Run by

James A. Haley Veterans Administration Hospital

People needed

44

Starts

2014-06-06

Expected to finish

2019-03-14

Last updated by the study team

2020-04-27

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female veteran outpatients aged 18-50 years old
• Meet DSM-IV criteria for PTSD as determined by clinical interview and CAPS for DSM-5
• A PTSD checklist - (PCL) ≥ 45 at Screening/Baseline
• On stable medication and/or psychotherapy for 1 month and clinically appropriate to maintain for duration of trial
• Clinically competent to give informed written consent

You may not qualify if…

• Veterans currently enrolled in an acute treatment of PTSD using evidence based psychotherapy including Prolonged Exposure Therapy (PE), Cognitive Processing Therapy (CPT), or Eye Movement Desensitization and Reprocessing (EMDR)
• History of epilepsy or seizure disorder, mass brain lesions, cerebrovascular accident, metal in the skull, a history of major head trauma defined as greater than mild TBI, or any neurologic condition likely to increase risk of rTMS.
• Suicidal risk that precludes safe participation defined as clinical impression that the subject is at significant risk for suicide.
• Lifetime history of schizophrenia, schizoaffective, or other psychotic disorder, bipolar disorder type I or II, dementia, dissociative disorders, or sexual and gender identity disorder
• Personality disorder that makes participation in the trial difficult
• History of problematic Substance Use Disorder in the last 3 months except nicotine and caffeine
• Taking any medication that significantly lowers the seizure threshold (e.g., stimulants, theophylline, first generation antipsychotics, etc.)
• Unstable medical conditions that precludes safe participation in rTMS treatment trial
• Known or suspected pregnancy
• Nursing mothers
• Women of child-bearing potential not using medically accepted form of contraception when engaged in sexual intercourse
• Any metal or device implants that would increase risk of rTMS
• Unable to determine the motor threshold in the subject
• History of Vagus Nerve Stimulation or Electroconvulsive Therapy
• Currently in another investigational study

Where it is running

• James A. Haley VAH — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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