Cranial Electrotherapy Stimulation in the Treatment of Posttraumatic Stress Disorder: A Feasibility, Safety and Efficacy Study

White River Junction Veterans Affairs Medical Center1 site in 1 country10 target enrollmentOctober 18, 2018

ConditionsPTSD, Post Traumatic Stress Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: PTSD, Post Traumatic Stress Disorder
Sponsor: White River Junction Veterans Affairs Medical Center
Enrollment: 10
Locations: 1
Primary Endpoint: Feasibility of Alpha-Stim® Cranial Electrotherapy Stimulation (CES) as a treatment for Posttraumatic Stress Disorder (PTSD).
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a research study that will look at how well a treatment called Cranial Electrotherapy Stimulation (CES) works for patients who struggle with symptoms of Posttraumatic Stress Disorder. Cranial Electrotherapy Stimulation is delivered using a device called Alpha-Stim®. This is a safe, non-invasive treatment that applies a low-level pulsed electric current through the brain using clip-on electrodes attached to the earlobes. Cranial Electrotherapy Stimulation treats conditions such as physical pain, anxiety, and depression.

Registry

clinicaltrials.gov

Start Date

October 18, 2018

End Date

September 21, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

White River Junction Veterans Affairs Medical Center

Responsible Party

Principal Investigator

James Rustad

Principal Investigator

White River Junction Veterans Affairs Medical Center

Eligibility Criteria

Inclusion Criteria

•To ensure participants can safely receive Alpha-Stim®, eligible participants must meet all established screening criteria for safety during Alpha-Stim® using a safety screener (as assessed during phone screen and medical records review). We are screening to access for metal. These are conservative measures require a patient not having the following (unless MRI-safe): Cardiac pacemaker, implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord. The patient would additionally be required to not have an implanted cardiac defibrillator;
•Outpatients 18-70 years of age (inclusive);
•Meet DSM-V criteria for PTSD (acute or chronic) at the time of the screening and/or baseline visit; symptoms.
•Have a baseline score of "Moderately Ill" or worse on the CGI-S;
•Be on a stable psychotropic regimen for at least 6 weeks prior to baseline, or no psychotropic medication at all (for at least 6 weeks prior to baseline), and be willing to maintain the current regimen and dosing for the duration of the study (unless medically necessary to make changes with notification of research staff);
•(7) If female and of child bearing potential, agree to use an acceptable method of birth control for the duration of the study treatment period; (8) Be willing and able to comply with all study related procedures and visits; (9) Be capable of independently reading and understanding patient information materials and giving written informed consent.

Exclusion Criteria

•Participants will be excluded from participation if they meet any of the following:
•Are pregnant or lactating or planning to become pregnant within the next three months;
•Have a lifetime history of loss of consciousness due to head injury for greater than 10 minutes, or any lifetime history of loss of consciousness due to a head injury with documented evidence of brain injury (including brain atrophy);
•Current (or past if appropriate) significant neurological disorder, or lifetime history of a) seizure disorder b) primary or secondary CNS tumors c) stroke or d) cerebral aneurysm;
•Unstable medical illness, or, in the opinion of the investigator, significant absence of appropriate medical care;
•Current Axis 1 primary psychotic disorder, or bipolar I disorder, active moderate/severe substance use disorders (within the last month as assessed by review of the medical records and veteran self-report, excluding nicotine/caffeine). Veterans on stable (\>3 months), monitored opiate agonist therapy may be included at the investigator's discretion;
•Past failed treatment with rTMS or ECT; any past treatment with deep brain stimulation or vagus nerve stimulation;
•Have active suicidal intent or plan as detected on screening assessments, or in the Investigator's opinion, is likely to attempt suicide within the next six months;
•Mental retardation or cognitive impairment
•History of stroke, Parkinson's Disease, Multiple Sclerosis, or seizures

Outcomes

Primary Outcomes

Feasibility of Alpha-Stim® Cranial Electrotherapy Stimulation (CES) as a treatment for Posttraumatic Stress Disorder (PTSD).

Time Frame: 1 year

We will deem the treatment feasible if ≥ 6 participants complete the protocol, based on completion of ≥ 60% treatments (3 out of 5 treatment days, weekly at home), and attending and completing ≥ 75% of the weekly assessments, including the week 1 baseline and week 4 treatment completion visit