Novel Treatment of Emotional Dysfunction in Post Traumatic Stress Disorder (PTSD)
1 other identifier
interventional
103
1 country
1
Brief Summary
The objective will be to determine if adding repetitive transcranial magnetic stimulation prior to Cognitive Processing Therapy significantly enhances recovery from hyperarousal symptoms in individuals with combat related post traumatic stress disorder and improves clinical outcome. The investigators have assembled a multimodal human performance laboratory including 64 channel EEG and repetitive transcranial magnetic stimulation system. These resources combined with the neuroimaging capabilities of the Advanced Imaging Research Center (AIRC) at UT Southwestern and skilled Cognitive Processing Therapy (CPT) practitioners will be used in this study. The study involves approximately 19 visits. Treatment is once a week for 12 weeks followed by a 1 month, 3 month and 6 month follow-up appointments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2011
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
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 5, 2011
CompletedFirst Posted
Study publicly available on registry
July 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedResults Posted
Study results publicly available
October 1, 2020
CompletedJanuary 22, 2024
January 1, 2024
4.6 years
July 5, 2011
August 5, 2020
January 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Follow-up in Clinician Administered Post-Traumatic Stress Disorder Scale Total Severity Score
The primary outcome measure of treatment efficacy for post-traumatic stress disorder (PTSD) will be change in the Clinician Administered Post-Traumatic Stress Disorder Scale (CAPS) Total Severity Score (i.e., summed across frequency and intensity ratings for the 17 PTSD assessment items) from baseline at 1-month post-treatment. CAPS Total Severity Score ranges from 0 to 136. Difference scores were calculated as the outcome score minus the baseline score, with negative scores indicating a reduction in symptom severity from baseline (i.e., a positive treatment outcome), and differences between treatment groups in change scores were evaluated using t-tests.
Outcome measures will be measured as change from baseline at 1-, 3-, and 6-month follow-ups
Secondary Outcomes (1)
Changes in ERP/CAPS Cluster Scores Signals From Pre-Treatment to Post-Treatment
Outcomes will be assessed at baseline and 6-month follow-up
Study Arms (2)
Sham rTMS
SHAM COMPARATORSham Treatment Intervention: Device: Repetitive Transcranial Magnet Stimulation (sham treatment)
active rTMS
ACTIVE COMPARATORActive Repetitive Transcranial Magnet Stimulation treatment Intervention: Device: Active rTMS of dorsolateral pre-frontal cortex
Interventions
For the sham rTMS with CPT group, the rTMS coil will be placed over the right prefrontal scalp region with the MagStim Rapid Stimulator set to the sham mode so that all conditions are similar to the active delivery mode except that transcranial magnetic stimulation is not administered to the scalp and does not down modulate the right frontal lobe.
Cognitive Processing Therapy (CPT) is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the combat related trauma.
For the active rTMS with CPT group, the rTMS coil will be placed over the right prefrontal scalp region with the MagStim Rapid Stimulator set to the active mode. After motor threshold determination, the stimulator coil is positioned over the dorsolateral prefrontal cortex - DLPFC (Brodmann Area 9/46). The right frontal rTMS will safely, reversibly, and temporarily down modulate the right frontal lobe. The conducting coil is placed over the scalp while electrical current pulses pass through the coil. This alternating current turned on and off rapidly produces magnetic pulses (1.5-2.0 Tesla strength) that last for 100 - 300 microseconds. The time-varying magnetic pulses induce an electrical field that will result in current flow in neural tissue, thereby activating or deactivating cortex subjacent to the coil.
Eligibility Criteria
You may qualify if:
- Veterans of Operation Iraqi Freedom (OIF) or Operation Enduring Freedom (OEF)
- years
- Diagnosis or symptoms of Combat related PTSD/ PCL Score Indicative of diagnosis (prior diagnosis not required).
- English speaking
- This study is also looking for civilian and miltary control subjects for assessment phase participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas at Dallas
Dallas, Texas, 75235, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. John Hart, Jr.
- Organization
- University of Texas at Dallas
Study Officials
- PRINCIPAL INVESTIGATOR
John Hart Jr., M.D.
The University of Texas at Dallas
- STUDY DIRECTOR
F. Andrew Kozel, M.D.
University of Texas
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 5, 2011
First Posted
July 12, 2011
Study Start
July 1, 2011
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
January 22, 2024
Results First Posted
October 1, 2020
Record last verified: 2024-01