Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01391832 |
| Other study ID # |
092010-035 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2011 |
| Est. completion date |
February 2016 |
Study information
| Verified date |
January 2024 |
| Source |
The University of Texas at Dallas |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
We will first screen participants between the ages of 18 and 60 years for symptoms of PTSD as
determined by subjective reporting. We will also screen for healthy control participants to
participate in comparison assessment phases of the study. After meeting pre-screen criteria,
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 approximately 19 visits. Treatment is once a week for 12 weeks
followed by a 1 month, 3 month and 6 month follow-up appointments.
- The first 2-3 visits involve an informed consent, a baseline assessment, EEG and
neuroimaging.
- Visits 4-15 are the rTMS/CPT sessions.
- Visit 16 is a 1 month follow-up, post-treatment assessment and EEG.
- Visit 17 is a post-treatment neuroimaging visit.
- Visit 18 is the 3 month follow up assessment.
- Visit 19 is the 6 month follow-up assessment.
