N/A N=103 Randomized Double-blind Treatment

Novel Treatment of Emotional Dysfunction in Post Traumatic Stress Disorder (PTSD)

Post Traumatic Stress Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01391832 ↗

Enrolled (actual)

103

Serious AEs

0.0%

Results posted

Oct 2020

Primary outcome: Primary: Change From Baseline to Follow-up in Clinician Administered Post-Traumatic Stress Disorder Scale Total Severity Score — -35.59; -44.164; -33.19; -44.95 change in scale score from baseline — p=>0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device); Cognitive Processing Therapy (Behavioral); Repetitive Transcranial Magnet Stimulation (rTMS) (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas at Dallas
Primary completion: Feb 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Follow-up in Clinician Administered Post-Traumatic Stress Disorder Scale Total Severity Score	-35.59; -44.164; -33.19; -44.95; -36.31; -47.76	>0.05
SECONDARY Changes in ERP/CAPS Cluster Scores Signals From Pre-Treatment to Post-Treatment	-1.2754; -0.6088	.3422

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.

Eligibility Criteria

Inclusion Criteria

Veterans of Operation Iraqi Freedom (OIF) or Operation Enduring Freedom (OEF)
18-60 years
Diagnosis or symptoms of Combat related PTSD/ PCL Score Indicative of diagnosis (prior diagnosis not required).
English speaking
Participants will be screened for exclusionary medical and mental health history.

This study is also looking for civilian and miltary control subjects for assessment phase participation.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01391832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.