Advertisement
Research Article| Volume 35, 100096, November 2022

Download started.

Ok

Cranial electrotherapy stimulation in the treatment of posttraumatic stress disorder: A feasibility, safety, and preliminary efficacy study

  • James K. Rustad
    Correspondence
    Corresponding author at: Department of Psychiatry, Geisel School of Medicine at Dartmouth, Lebanon, NH 03766, USA.
    Affiliations
    Department of Mental Health and Behavioral Sciences, White River Junction VA Medical Center, White River Junction, VT 05009, USA

    Department of Psychiatry, Geisel School of Medicine at Dartmouth, Lebanon, NH 03766, USA

    Department of Psychiatry, Larner College of Medicine at the University of Vermont, Burlington, VT 05401, USA
    Search for articles by this author
  • Ryan P. Waaland
    Affiliations
    Dartmouth College, Hanover, NH 03755, USA
    Search for articles by this author
  • Lauren M. Sippel
    Affiliations
    Department of Psychiatry, Geisel School of Medicine at Dartmouth, Lebanon, NH 03766, USA

    VA Northeast Program Evaluation Center, West Haven, CT 06516, USA

    National Center for PTSD Evaluation Division, West Haven, CT 06516, USA
    Search for articles by this author
  • Pablo Martinez-Camblor
    Affiliations
    Department of Anesthesiology and Department of Biomedical Data Sciences, Geisel School of Medicine at Dartmouth, Lebanon, NH 03766, USA
    Search for articles by this author
  • Samuel I. Kohrman
    Affiliations
    Massachusetts General Hospital/Harvard Medical School, Boston, MA 02114, USA
    Search for articles by this author
  • H. Samuel Landsman
    Affiliations
    Department of Psychiatry, Geisel School of Medicine at Dartmouth, Lebanon, NH 03766, USA
    Search for articles by this author
  • Krista Buckley
    Affiliations
    Department of Psychiatry, Larner College of Medicine at the University of Vermont, Burlington, VT 05401, USA
    Search for articles by this author
  • Paul E. Holtzheimer
    Affiliations
    Department of Mental Health and Behavioral Sciences, White River Junction VA Medical Center, White River Junction, VT 05009, USA

    Department of Psychiatry, Geisel School of Medicine at Dartmouth, Lebanon, NH 03766, USA

    National Center for PTSD Executive Division, White River Junction, VT 05009, USA

    Department of Surgery, Geisel School of Medicine at Dartmouth, Lebanon, NH 03756, USA
    Search for articles by this author
Published:September 08, 2022DOI:https://doi.org/10.1016/j.pmip.2022.100096

      Abstract

      Background

      Neuromodulation of brain circuits important for affect, behavior, and cognition may decrease the symptomatology and functional impairment of military veterans suffering from posttraumatic stress disorder (PTSD). Cranial electrotherapy stimulation (CES) techniques, such as Alpha-Stim®, have demonstrated preliminary benefit for symptoms that commonly co-occur with PTSD, such as pain, anxiety, depression, and insomnia. However, CES has not yet been specifically tested as a treatment for PTSD. The objective of this open-label pilot study was to examine feasibility, safety, and preliminary efficacy of Alpha-Stim® for treatment of PTSD.

      Methods

      Open-label Alpha-Stim® was administered to nine veterans who were diagnosed with PTSD via structured interview (Clinician-Administered PTSD Scale for DSM-5 [CAPS-5]) and were taking at least one psychotropic medication. Treatment consisted of 20 CES sessions administered at home over 40 days. Effects on PTSD symptoms, functioning, depression symptoms, pain, anxiety symptoms, and insomnia were assessed at baseline and every week of treatment for four weeks. Effects on PTSD symptoms, depression symptoms, and pain were assessed one month and three months post-treatment.

      Results

      Seven patients (78%) successfully completed treatment. There were no adverse events. Following four weeks of Alpha-Stim® treatment, PTSD symptoms decreased by 38%, depression symptoms decreased by 52%, insomnia decreased by 34%, and pain decreased by 11%. Significant improvements in PTSD and depression, but not pain, persisted at one-month and three-months posttreatment. Presumptive loss of diagnosis rates (i.e., PTSD Checklist for DSM-5 total score below 33) immediately following treatment and one and three months later were 43%, 33%, and 29%, respectively.

      Conclusions

      Alpha-Stim® showed an excellent safety profile with no adverse effects. The results suggest preliminary efficacy for improving PTSD symptoms as well as concomitant depression symptoms, insomnia, and pain. Limitations of this pilot study include the open-label, uncontrolled design and small sample size. These results support additional larger, randomized controlled trials of Alpha-Stim® for veterans with PTSD.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Personalized Medicine in Psychiatry
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Watts B.V.
        • Landon B.
        • Groft A.
        • Young-Xu Y.
        A sham controlled study of repetitive transcranial magnetic stimulation for posttraumatic stress disorder.
        Brain Stimulat. 2012; 5: 38-43
        • Kirsch D.L.
        • Price L.R.
        • Nichols F.
        • et al.
        Military service member and veteran self-reports of efficacy of cranial electrotherapy stimulation for anxiety, posttraumatic stress disorder, insomnia, and depression.
        US Army Medical Department Journal. 2014; : 46-54
        • Bracciano A.G.
        • Chang W.-P.
        • Kokesh S.
        • Martinez A.
        • Meier M.
        • Moore K.
        Cranial electrotherapy stimulation in the treatment of posttraumatic stress disorder: a pilot study of two military veterans.
        J Neurother. 2012; 16: 60-69
        • De Felice E.A.
        Cranial electrotherapy stimulation (CES) in the treatment of anxiety and other stress-related disorders: a review of controlled clinical trials.
        Stress Med. 1997; 13: 31-42
        • Kirsch D.L.
        • Gilula M.F.
        CES in the treatment of depression.
        Pract Pain Manage. 2007; 7: 33-41
        • Kirsch D.L.
        • Smith R.B.
        Cranial electrotherapy stimulation for anxiety, depression, insomnia, cognitive dysfunction, and pain: a review and meta-analyses.
        in: Rousch P.J. Markov M.S. Bioelectromagnetic medicine. Mercel Dekker, New York, NY2004: 1-27
        • Gilula M.F.
        • Kirsch D.L.
        Cranial electrotherapy stimulation review: a safer alternative to psychopharmaceuticals in the treatment of depression.
        J Neurother. 2005; 9: 7-26
        • Francati V.
        • Vermetten E.
        • Bremner J.D.
        Functional neuroimaging studies in posttraumatic stress disorder: review of current methods and findings.
        Depress Anxiety. 2007; 24: 202-218
        • McEwen B.S.
        The neurobiology and neuroendocrinology of stress: Implications for post-traumatic stress disorder from a basic science perspective.
        Psychiatr Clin North Am. 2002; 25: 469-494
        • Tan G.
        • Dao T.K.
        • Smith D.L.
        • Robinson A.
        • Jensen M.P.
        Incorporating complementary and alternative medicine (CAM) therapies to expand psychological services to veterans suffering from chronic pain.
        Psychol Serv. 2010; 7: 148-161
      1. Weathers, F.W., Litz, B.T., Keane, T.M., et al. (2013). The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www.ptsd.va.gov.

      2. Weathers, F.W., Blake, D.D., Schnurr, P.P., et al. (2013). The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Interview available from the National Center for PTSD at www.ptsd.va.gov.

        • Taylor A.G.
        • Anderson J.G.
        • Riedel S.L.
        • Lewis J.E.
        • Kinser P.A.
        • Bourguignon C.
        Cranial electrical stimulation improves symptoms and functional status in individuals with fibromyalgia.
        Pain Manage Nurs. 2013; 14: 327-335
        • Barclay T.H.
        • Barclay R.D.
        A clinical trial of cranial electrotherapy stimulation for anxiety and comorbid depression.
        J Affect Disord. 2014; 164: 171-177
        • Bystritsky A.
        • Kerwin L.
        • Feusner J.
        A pilot study of cranial electrotherapy stimulation for generalized anxiety disorder.
        J Clin Psychiatry. 2008; 69: 412-417
      3. Rush, A.J., Trivedi, M.H., Ibrahim, H.M., et al. (2003). The 16-Iteam Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biological Psychiatry 54(5), 573-583 Erratum p. 585.

        • Bovin M.J.
        • Black S.K.
        • Rodriguez P.
        • Lunney C.A.
        • Kleiman S.E.
        • Weathers F.W.
        • et al.
        Development and validation of a measure of PTSD-related psychosocial functional impairment: The Inventory of Psychosocial Functioning.
        Psychol Serv. 2018; 15: 216-229
        • Montgomery S.A.
        • Åsberg M.
        A new depression scale designed to be sensitive to change.
        Br J Psychiatry. 1979; 134: 382-389
        • King P.R.
        • Donnelly K.T.
        • Donnelly J.P.
        • Dunnam M.
        • Warner G.
        • Kittleson C.J.
        • et al.
        Psychometric study of the neurobehavioral symptom inventory.
        J Rehabil Res Dev. 2012; 49: 879
        • Spitzer R.L.
        • Kroenke K.
        • Williams J.B.W.
        • Löwe B.
        A brief measure for assessing Generalized Anxiety Disorder.
        Arch Intern Med. 2006; 166: 1092
        • Buysse D.J.
        • Reynolds C.F.
        • Monk T.H.
        • Berman S.R.
        • Kupfer D.J.
        The pittsburgh sleep quality index: a new instrument for psychiatric practice and research.
        Psychiatry Res. 1989; 28: 193-213
        • Bovin M.J.
        • Marx B.P.
        • Weathers F.W.
        • Gallagher M.W.
        • Rodriguez P.
        • Schnurr P.P.
        • et al.
        Psychometric properties of the PTSD checklist for diagnostic and statistical manual of mental disorders-fifth edition (PCL-5) in veterans.
        Psychol Assess. 2016; 28: 1379-1391
        • Schnurr P.
        • Lunney C.
        Residual symptoms following prolonged exposure and present-centered therapy for PTSD in female veterans and soldiers.
        Depress Anxiety. 2018; 36: 162-169
        • Larsen S.E.
        • Fleming C.J.E.
        • Resick P.A.
        Residual symptoms following empirically supported treatment for PTSD.
        Psychol Trauma Theory Res Pract Policy. 2019; 11: 207-215
        • Sippel L.M.
        • Holtzheimer P.E.
        • Friedman M.J.
        • Schnurr P.P.
        Defining treatment-resistant posttraumatic stress disorder: a framework for future research.
        Biol Psychiatry. 2018; 84: e37-e41
        • Zaghi S.
        • Acar M.
        • Hultgren B.
        • Boggio P.S.
        • Fregni F.
        Noninvasive brain stimulation with low-intensity electrical currents: putative mechanisms of action for direct and alternating current stimulation.
        Neuroscientist. 2010; 16: 285-307
      4. Shekelle, P., Cook, I., Miake-Lye, I.M., et al. (2018). “The Effectiveness and Risks of Cranial Electrical Stimulation for the Treatment of Pain, Depression, Anxiety, PTSD, and Insomnia: A Systematic Review.” Washington (DC): Department of Veterans Affairs (US). https://www.ncbi.nlm.nih.gov/books/NBK493132/ Accessed on April 12, 2022.