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

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ClinicalTrials.gov Identifier: NCT03757494
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
James Rustad, White River Junction Veterans Affairs Medical Center

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.

Condition or disease Intervention/treatment Phase
PTSD, Post Traumatic Stress Disorder Device: Alpha Stim Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Using Alpha Stim
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Cranial Electrotherapy Stimulation in the Treatment of Posttraumatic Stress Disorder: A Feasibility, Safety and Efficacy Study
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Use of Alpha Stim
Use of Alpha Stim Device
Device: Alpha Stim
Use of Alpha Stim Device




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Safety of the Alpha-Stim® Cranial Electrotherapy Stimulation (CES) as a treatment for Posttraumatic Stress Disorder. [ Time Frame: 1 year ]
    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.


Other Outcome Measures:
  1. Efficacy of Alpha-Stim® Cranial Electrotherapy Stimulation (CES) as a treatment for Posttraumatic Stress Disorder. [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757494


Contacts
Contact: James K Rustad, MD 802-295-9363 ext 7095 james.rustad@va.gov
Contact: H. Samuel Landsman, MD 802-295-9363 ext 5760 h.landsman@va.gov

Locations
United States, Vermont
White River Junction VAMC Recruiting
White River Junction, Vermont, United States, 05009
Contact: James K Rustad, MD    802-295-9363 ext 7095    james.rustad@va..gov   
Contact: H. Samuel Landsman, MD    802-295-9363 ext 5760    h.landsman@va.gov   
Sub-Investigator: H. Samuel Landsman, MD         
Sub-Investigator: Paul E Holtzheimer, MD         
Sponsors and Collaborators
White River Junction Veterans Affairs Medical Center

Responsible Party: James Rustad, Principal Investigator, White River Junction Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT03757494     History of Changes
Other Study ID Numbers: 1286051
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders