Cranial Electrotherapy Stimulation (CES) to Treat PTSD (CES-fMRI-PTSD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Mclean Hospital
Sponsor:
Collaborator:
Mending Minds Foundation, Ellen Ratner
Information provided by (Responsible Party):
Scott Lukas, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01860677
First received: May 20, 2013
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

Use of the Fischer Wallace Cranial Stimulator to relieve symptoms related to PTSD.


Condition Intervention
Treatment of PTSD Symptoms
Device: Fisher Wallace Cranial Stimulator

Study Type: Interventional
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

Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 16
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)
Arms Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets DSM-IV criteria for PTSD
  • 21 to 40 years old
  • Otherwise physically healthy (normal physical exam, ECG, blood and urine chemistries)
  • Female participants must use medically approved method of contraception. If barrier method is used, they must agree to using two methods simultaneously (e.g., diaphragm and condom).
  • If on antidepressant or antianxiety medication, must be on a stable prescription regimen with no intentions to change drugs or dose during the next 11 weeks.

Exclusion Criteria:

  • Opiate maintenance (e.g., methadone or buprenorphine)
  • Drug use (other than nicotine, alcohol, or marihuana) greater than 50 lifetime uses.
  • Meets criteria for current drug abuse or dependence (other than nicotine, alcohol, or marihuana). Past abuse/dependence (greater than 3 years) is acceptable.
  • Meets criteria for alcohol dependence. Past abuse/dependence (greater than 3 years) is acceptable. They may meet criteria for alcohol abuse.
  • Physical health problems
  • History of significant cardiac problems
  • History of seizures
  • Pregnancy
  • Persons with a demand-type cardiac pacemaker
  • Persons receiving vagus nerve simulation
  • Persons receiving deep brain stimulation
  • Participants cannot have any conditions that are contraindicated for MRI
  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: NCT01860677

Locations
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Scott E Lukas, PhD    617-855-2767    slukas@mclean.harvard.edu   
Contact: David M Penetar, PhD    617-855-2913    dpenetar@mclean.harvard.edu   
Principal Investigator: Scott E Lukas, PhD         
Sponsors and Collaborators
Mclean Hospital
Mending Minds Foundation, Ellen Ratner
Investigators
Principal Investigator: Scott E Lukas, PhD McLean Imaging Center, McLean Hospital
  More Information

Publications:
Responsible Party: Scott Lukas, Director, McLean Imaging Center, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01860677     History of Changes
Other Study ID Numbers: P-001567
Study First Received: May 20, 2013
Last Updated: May 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
PTSD
cranial stimulation
fMRI (BOLD)
spectroscopy

ClinicalTrials.gov processed this record on October 01, 2014