Cranial Electrotherapy Stimulation (CES) to Treat PTSD

Treatment of PTSD Symptoms Clinical Trial

— CES-fMRI-PTSD  

Official title:

Cranial Electrotherapy Stimulation (CES) to Treat PTSD: Identifying Metrics of Efficacy Using Brain Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01860677
• Other study ID #: P-001567
• Status: Recruiting
• Phase: N/A
• First received: May 20, 2013
• Last updated: May 22, 2013
• Start date: May 2010
• Est. completion date: May 2015

Study information

• Verified date: May 2013
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: May 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Treatment of PTSD Symptoms

Intervention

Device:
• Fisher Wallace Cranial Stimulator

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	Mending Minds Foundation, Ellen Ratner

Country where clinical trial is conducted

United States, 

References & Publications (2)

Gilula MF, Barach PR. Cranial electrotherapy stimulation: a safe neuromedical treatment for anxiety, depression, or insomnia. South Med J. 2004 Dec;97(12):1269-70. — View Citation

Smith RB (2006) Cranial electrotherapy stimulation: Its first fifty years, plus three: a monograph. Oklahoma: Tate Publishing & Enterprises

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BOLD fMRI and spectroscopy (neural activation patterns/brain function)	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.	6 weeks	No
Secondary	Clinician-Administered PTSD Scale (CAPS)	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.	6 weeks	No