Study Testing if Fast or Slow rTMS is Better for the Treatment of Posttraumatic Stress Disorder (PTSD)
Randomized Trial of 1 Hz Versus 10 Hz Right Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Posttraumatic Stress Disorder (PTSD)
1 other identifier
interventional
44
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2014
CompletedStudy Start
First participant enrolled
June 6, 2014
CompletedFirst Posted
Study publicly available on registry
June 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2019
CompletedResults Posted
Study results publicly available
April 7, 2020
CompletedApril 27, 2020
April 1, 2020
4.8 years
May 30, 2014
April 9, 2019
April 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change Clinical-Administered Post Traumatic - DSM-5
Standard administration and scoring of the CAPS-5 are essential for producing reliable and valid scores and diagnostic decisions. Clinical-Administered Post Traumatic -DSM-5 (CAPS-5) 30 items, score ranging from 0-50. CAPS-5 symptom severity ratings are based on symptom frequency and intensity. Intensity rating of Minimal corresponds to a severity rating of Mild/subthreshold, Clearly Present corresponds with Moderate/threshold, Pronounced corresponds with Severe/markedly elevated, and Extreme corresponds with Extreme/ incapacitating. Administered at baseline and after 30 rTMS treatment.
Baseline and after 30 rTMS Treatments (approximately 6 weeks)
Change in IPF: Inventory of Psychosocial Functioning
Change Inventory of Psychosocial Functioning (IPF) Administered at baseline and after 30 rTMS treatments. The IPF is an 80 question self-report scale that assessed function in the areas of family, work,friendships and socializing, parenting, education, self-care, and romantic relationships with spouse or partner. The rate is based on how often participant acted over the past 30 days. Domains are averaged with resulting score range 1 - 7. 1 Never - 7 Always.
Baseline and after 30 rTMS Treatments (approximately 6 weeks)
Study Arms (2)
Right slow prefrontal rTMS
ACTIVE COMPARATORRepetitive Transcranial Magnetic Stimulation
Right fast prefrontal rTMS
ACTIVE COMPARATORRepetitive Transcranial Magnetic Stimulation
Interventions
TMS Device
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
James A. Haley VAH
Tampa, Florida, 33612, United States
Related Publications (1)
Kozel FA, Van Trees K, Larson V, Phillips S, Hashimie J, Gadbois B, Johnson S, Gallinati J, Barrett B, Toyinbo P, Weisman M, Centorino M, Gibson CA, Catalano G. One hertz versus ten hertz repetitive TMS treatment of PTSD: A randomized clinical trial. Psychiatry Res. 2019 Mar;273:153-162. doi: 10.1016/j.psychres.2019.01.004. Epub 2019 Jan 3.
PMID: 30641346RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Treaters and patients were not masked. Raters masked and separated. No clear expectations of outcome for 1 Hz versus 10 Hz. Future studies should consider sham controlled trial. No biomarkers obtained in this study.
Results Point of Contact
- Title
- F. Andrew Kozel
- Organization
- James A. Haley VA Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
F. Andrew Kozel, MD, MSCR.
James A. Haley VAH
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of TMS Program & Staff Psychiatrist
Study Record Dates
First Submitted
May 30, 2014
First Posted
June 9, 2014
Study Start
June 6, 2014
Primary Completion
March 14, 2019
Study Completion
March 14, 2019
Last Updated
April 27, 2020
Results First Posted
April 7, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share