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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by The University of Texas at Dallas.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
The University of Texas at Dallas
ClinicalTrials.gov Identifier:
NCT01391832
First received: July 5, 2011
Last updated: January 20, 2012
Last verified: July 2011
  Purpose

The objective will be to determine if adding repetitive transcranial magnetic stimulation prior to Cognitive Processing Therapy significantly alters measures of arousal 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 16 visits over the course of roughly 16 weeks with a 6-month follow-up assessment via telephone.


Condition Intervention
Post Traumatic Stress Disorder
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Behavioral: Cognitive Processing Therapy
Device: Repetitive Transcranial Magnet Stimulation (rTMS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Novel Treatment of Emotional Dysfunction in PTSD

Resource links provided by NLM:


Further study details as provided by The University of Texas at Dallas:

Primary Outcome Measures:
  • Change in CAPS-2 score [ Time Frame: Outcome measures will be measured periodically over a period of one year ] [ Designated as safety issue: No ]
    The primary outcome measure of treatment efficacy for PTSD will be the CAPS-2 score changes. These will be analyzed by comparing the post-treatment scores to pre-treatment scores, using paired t-tests for each treatment group. A secondary analysis that we will perform to determine if the rTMS-CPT treatment improves PTSD arousal symptoms is to compare post- to pre-treatment PTSD scores for the CAPS-2 for cluster 'D' scores.


Secondary Outcome Measures:
  • Changes in ERP/CAPS-2 cluster scores/fMRI BOLD signals from Pre-Treatment to Post-Treatment [ Time Frame: Outcome measures will be measured periodically for a period of one year ] [ Designated as safety issue: No ]
    The secondary outcome measures will be a) the ERP measures of P3a amplitude for hyperarousal to combat threatening stimuli will be compared from post- to pre-treatment b) The total CAPS-2 scores from pre-treatment and post-treatment will be compared; and c) The fMRI BOLD signals will be compared post- to pre-treatment


Estimated Enrollment: 100
Study Start Date: July 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham rTMS
Sham Treatment Intervention: Device: Repetitive Transcranial Magnet Stimulation (sham treatment)
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
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.
Other Names:
  • rTMS
  • magnet stimulation
Behavioral: Cognitive Processing Therapy
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.
Other Names:
  • CPT
  • behavioral training
  • behavioral therapy
  • cognitive processing therapy
Active Comparator: active rTMS

Active Repetitive Transcranial Magnet Stimulation treatment

Intervention: Device: Active rTMS of dorsolateral pre-frontal cortex

Behavioral: Cognitive Processing Therapy
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.
Other Names:
  • CPT
  • behavioral training
  • behavioral therapy
  • cognitive processing therapy
Device: Repetitive Transcranial Magnet Stimulation (rTMS)
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.

Detailed Description:

We will first screen participants between the ages of 18 and 45 years with PTSD for the symptom of hyperarousal, as determined by subjective reporting of hyperarousal symptoms of PTSD. If these are present, a more extensive screening to determine the eligibility of each subject will be performed. This will be followed by an EEG. The EEG system measures event-related potentials (ERPs), which explain certain cognitive processes based on changes in the amplitude and timing of electrical changes recorded from the surface of the scalp. We will use an ERP task that includes combat-threatening stimuli as the novel oddball probe to assess P300 response. The amplitude of the P300 (positive amplitude recorded 300 milliseconds after stimulus onset) is used to differentiate between hypo-, normo-, and hyper-arousability. Identifying those with hyperarousal on P300 response on ERP allows for identification of PTSD patients with subjective and objective measures of hyperarousal. The participants will then be scheduled for a neuroimaging session. During neuroimaging, participants will have structural and functional brain scans acquired, including a functional MRI scan using the same threatening/nonthreatening stimuli, thus providing another objective measure of hyperarousal.

Participants will then have active or sham 1 Hz repetitive transcranial magnetic stimulation (rTMS) administered to the right frontal lobe as well as Cognitive Processing Therapy (CPT) once per week for twelve weeks (total 12 rTMS-CPT sessions). Studies have shown that rTMS applied externally to the forehead in the region of the dorsal lateral forehead will safely, reversibly, and painlessly down-modulate the frontal lobe on the side of the head to which it is applied. Our preliminary studies have shown that application of frontal rTMS can reduce the response to threatening stimuli temporarily and this can optimize the effectiveness of the CPT. Following the 12 sessions of rTMS-CPT, the EEG and neuroimaging will be repeated to test for changes in brain function.

In summary, the study involves 16 visits over the course of roughly 16 weeks with a 6-month follow-up assessment via telephone. The first visit involves an informed consent, a baseline assessment and EEG. The second visit is a neuroimaging visit. Visits 3-14 are the rTMS/CPT sessions. Visit 15 is a post-treatment baseline assessment and EEG. Visit 16 is a post-treatment neuroimaging visit. Finally a 6-month follow-up assessment via telephone will conclude the subjects participation in the study.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans of Operation Iraqi Freedom (OIF) or Operation Enduring Freedom (OEF)
  • 18-45 years
  • Diagnosis of Combat related PTSD/ PCL Score Indicative of diagnosis
  • English speaking

Exclusion Criteria:

  • History of eating disorders
  • Psychotic Symptoms
  • Obsessive Compulsive Disorder
  • History of a neurological disorder, including traumatic brain injury (moderate to severe)
  • Loss of Consciousness greater than 30 minutes
  • Open wound/penetrating trauma
  • No major symptoms such as seizures
  • Traumatic Brain Injury will be screened by both history and review for significant lesions indicative of TBI on their structural MRI scan obtained during the neuroimaging session.
  • Brain Tumors
  • Current Substance Abuse
  • Stroke
  • Blood Vessel abnormalities in the Brain
  • Dementia
  • Parkinson's disease
  • Huntington's chorea
  • Multiple Sclerosis
  • Pregnant or Nursing Mothers
  • Seizure history
  • Cardiac Pacemaker
  • Implanted Medication Pumps of ANY sort
  • History of significant heart disease
  • Myocardial infarction
  • Tachyarrhythmia
  • Congestive Heart Failure
  • Valvular Disease
  • Any metal object in or near the head which cannot be safely removed for the duration of the study
  • Use of prescription medication or illegal substances that lower the seizure threshold
  • Any condition that becomes apparent that might indicate an increased risk from rTMS therapy
  • Currently involved in any other evidence based psychoeducational study or treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391832

Contacts
Contact: Cassie R Morgan, B.A. 9728833240 ext 3240 cassie.morgan@utdallas.edu
Contact: Tina Bass, M.S. 9728833216 ext 3216 christina.bass@utdallas.edu

Locations
United States, Texas
Center for BrainHealth Recruiting
Dallas, Texas, United States, 75235
Contact: Cassie R Morgan, B.A.    972-883-3240 ext 3240    cassie.morgan@utdallas.edu   
Contact: Monique Salinas, B.S.    9728833278 ext 3278    mns103020@utdallas.edu   
Principal Investigator: John Hart Jr., M.D.         
Sub-Investigator: Sandra Chapman, Ph.D         
Sponsors and Collaborators
The University of Texas at Dallas
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: John Hart Jr., M.D. University of Texas at Dallas
Study Director: F. Andrew Kozel, M.D. University of Texas
Study Director: Sandra Chapman, Ph.D University of Texas at Dallas
  More Information

Additional Information:
No publications provided

Responsible Party: The University of Texas at Dallas
ClinicalTrials.gov Identifier: NCT01391832     History of Changes
Other Study ID Numbers: 092010-035
Study First Received: July 5, 2011
Last Updated: January 20, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by The University of Texas at Dallas:
rTMS
PTSD
Post Traumatic Stress Disorder
repetitive transcranial magnetic stimulation
combat related PTSD
OEF
OIF
Veterans
operation enduring freedom
operation iraqi freedom
CPT
cognitive processing therapy

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Disease
Stress Disorders, Post-Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014