Cranial Electrotherapy Stimulation in the Treatment of Posttraumatic Stress Disorder (CES)

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

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.

Study Overview

• Status: Completed
• Conditions: PTSD, Post Traumatic Stress Disorder
• Intervention / Treatment: Device: Alpha Stim

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Vermont
    • White River Junction, Vermont, United States, 05009
      • White River Junction VAMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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;
2. Outpatients 18-70 years of age (inclusive);
3. Meet DSM-V criteria for PTSD (acute or chronic) at the time of the screening and/or baseline visit; symptoms.
4. Have a baseline score of "Moderately Ill" or worse on the CGI-S;
5. 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.

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Exclusion Criteria:

Participants will be excluded from participation if they meet any of the following:

1. Are pregnant or lactating or planning to become pregnant within the next three months;
2. 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);
3. 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;
4. Unstable medical illness, or, in the opinion of the investigator, significant absence of appropriate medical care;
5. 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;
6. Past failed treatment with rTMS or ECT; any past treatment with deep brain stimulation or vagus nerve stimulation;
7. 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;
8. Mental retardation or cognitive impairment
9. History of stroke, Parkinson's Disease, Multiple Sclerosis, or seizures
10. Current use of Transcutaneous electrical nerve stimulation (TENS) unit
11. Previous history of Alpha-Stim® use
12. Inability to read and write in English
13. Incapacity to make informed medical decisions for any reason
14. Pregnancy: Pregnant women are not eligible for the study. Women with potential for pregnancy will receive a pregnancy test provided by the VA prior to the study. Women of childbearing capacity are eligible for the study. Contraceptive plans will be discussed and if they are determined to be inadequate, the participant will be excluded from the study.
15. Presence of an implanted defibrillator or pacemaker device.

16. Demonstrate the presence of any other condition or circumstance that, in the opinion of the investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Use of Alpha Stim; Use of Alpha Stim Device	Device: Alpha Stim; Use of Alpha Stim Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Alpha-Stim® Cranial Electrotherapy Stimulation (CES) as a treatment for Posttraumatic Stress Disorder (PTSD).	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the Alpha-Stim® Cranial Electrotherapy Stimulation (CES) as a treatment for Posttraumatic Stress Disorder.	Safety and tolerability, we expect this treatment to be safe, based on the very few adverse events and no serious adverse events in the literature and relative safety when compared to current pharmacologic treatments (e.g., SSRIs and SNRIs) for PTSD.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Alpha-Stim® Cranial Electrotherapy Stimulation (CES) as a treatment for Posttraumatic Stress Disorder.	Efficacy, while the study isn't powered for an efficacy trial, the initial screening to baseline pretreatment to post-treatment change in the magnitude of change in PTSD symptoms (as measured by the PCL-5) during Alpha-Stim® treatment using paired t-tests can be used to determine sample size and power calculations for future studies.	1 year

Collaborators and Investigators

• Sponsor: White River Junction Veterans Affairs Medical Center
• Investigators: Principal Investigator: James K Rustad, MD, White River Junction Veterans Affairs Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 18, 2018
• Primary Completion (ACTUAL): September 21, 2022
• Study Completion (ACTUAL): September 21, 2022

Study Registration Dates

• First Submitted: October 17, 2018
• First Submitted That Met QC Criteria: November 26, 2018
• First Posted (ACTUAL): November 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 27, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 1286051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes