High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in PTSD
rTMS
1 other identifier
interventional
37
1 country
1
Brief Summary
The purpose of this study is to compare two slightly different methods of transcranial magnetic stimulation (TMS) to treat Post Traumatic Stress Disorder (PTSD)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Apr 2012
Typical duration for early_phase_1
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
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
August 19, 2016
CompletedAugust 22, 2016
August 1, 2016
2.5 years
September 30, 2014
August 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinician Administered PTSD Scale , CAPS
The CAPS is the gold-standard, semi-structured interview that corresponds to DSM-IV criteria for PTSD.
day 10
Secondary Outcomes (1)
Posttraumatic Stress Disorder Checklist, PCL
week 24
Study Arms (3)
Treatment as usual
NO INTERVENTIONTreatment as usual, wait list control group
rTMS at 10Hz
ACTIVE COMPARATOR10 Hz rTMS of the right dorsolateral prefrontal cortex
rTMS at 20Hz
ACTIVE COMPARATOR20 Hz rTMS of the right dorsolateral prefrontal cortex
Interventions
Ten sessions of 10 Hz rTMS of the right dorsolateral prefrontal cortex
Ten sessions of 20 Hz rTMS of the right dorsolateral prefrontal cortex
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NMCSD
San Diego, California, 92134, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc A Capobianco, MD, DFAPA
NMCSD
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2014
First Posted
August 19, 2016
Study Start
April 1, 2012
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
August 22, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share