Cranial Electrotherapy Stimulation (CES) to Treat PTSD (CES-fMRI-PTSD)
Recruitment status was Recruiting
Use of the Fischer Wallace Cranial Stimulator to relieve symptoms related to PTSD.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Cranial Electrotherapy Stimulation (CES) to Treat PTSD: Identifying Metrics of Efficacy Using Brain Imaging|
- BOLD fMRI and spectroscopy (neural activation patterns/brain function) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]For PTSD-diagnosed participants: Three weeks of daily treatments (Monday-Friday) of CES will result in quantitative changes in neural activation patterns during task performance as measured by BOLD functional MRI. A secondary hypothesis is that these changes in brain function will parallel an improvement in mood which will be reflected in changes in resting state MRI scans.
- Clinician-Administered PTSD Scale (CAPS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]The CAPS is the gold standard in PTSD assessment. The CAPS is a 30-item structured interview that corresponds to the DSM-IV criteria for PTSD. The CAPS can be used to make a current (past month) or lifetime diagnosis of PTSD or to assesses symptoms over the past week. In addition to assessing the 17 PTSD symptoms, questions target the impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and frequency and intensity of five associated symptoms (guilt over acts, survivor guilt, gaps in awareness, depersonalization, and derealization). For each item, standardized questions and probes are provided. As part of the trauma assessment (Criterion A), the Life Events Checklist (LEC) is used to identify traumatic stressors experienced. CAPS items are asked in reference to up to three traumatic stressors.
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Active stimulation
The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.
|Device: Fisher Wallace Cranial Stimulator|
Placebo Comparator: Sham stimulation
Participants are outfitted with a device that is identical in appearance but does not deliver any current.
The advent of an appreciation that alternative and complementary practices can have some beneficial effect on health has prompted the question of whether there are empirical measures of improvement that do not rely solely on subjective reports. The present study proposes to explore whether transcranial stimulation (or cranial electrotherapy stimulation; CES) using an FDA-approved device can alter brain function, mood and responses to cognitive tasks in patients diagnosed with Post Traumatic Stress Disorder (PTSD). Furthermore, the study will test whether such changes parallel clinical improvement in signs and symptoms. The dependent variables of interest will be magnetic resonance imaging (MRI). Secondarily, we will assess the effects of CES on brain chemistry through the use of magnetic resonance spectroscopy procedures in normal, healthy control participants.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01860677
|United States, Massachusetts|
|Belmont, Massachusetts, United States, 02478|
|Contact: Scott E Lukas, PhD 617-855-2767 firstname.lastname@example.org|
|Contact: David M Penetar, PhD 617-855-2913 email@example.com|
|Principal Investigator: Scott E Lukas, PhD|
|Principal Investigator:||Scott E Lukas, PhD||McLean Imaging Center, McLean Hospital|