EEG-based Personalized Transcranial Magnetic Stimulation (eTMS) to Treat Post-Traumatic Stress Disorder

NCT06892028 | Recruiting DMC FDA Device

• 2 other identifiers: eTMS-PTSD-001-Stage 22021 RFP # SRC2472 DMH009
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomized, sham controlled study of the Electroencephalogram (EEG) based Transcranial Magnetic Stimulation (eTMS) treatment for Post-Traumatic Stress Disorder (PTSD). The recruitment goal is 110 participants who are United States Military veterans or first responders (e.g., firefighters, police, paramedics, etc.). The Study includes an EEG recording in order to determine the optimal treatment parameters for the eTMS system, followed by 15 in-office visits that take place over 21-28 total days. Two eTMS treatment sessions are administered during each office visit.

Conditions

Stress Disorder, Post Traumatic

Keywords

PTSD; Veterans; First Responders

Outcome Measures

Primary Outcomes (1)

• Improvement in PTSD Symptoms as Measured by Drop in Score on the PTSD Checklist for DSM-5 (PCL-5)

  The Post Traumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. (DSM-5), commonly referred to as PCL-5, is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. It is used to monitor symptom change during and after treatment. Each item is scored from 0 to 5 as the participant's estimate of the severity of the symptom (0 = Not at all, 1=A little bit, 2 = Moderately, 3 = Quite a bit, 4 = Extremely). The final score range is between 0-80. A lower score is considered better than a higher score.

  Baseline and Final Measure, between 21-28 Days

Secondary Outcomes (1)

• Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study.

  Baseline and Final Measure, between 21-28 Days

Study Arms (2)

Active eTMS treatment

ACTIVE COMPARATOR

15 treatment days of EEG-based personalized TMS over a maximum of 28 days. Two sessions per treatment day. Each session consists of TMS treatment at 80% Motor Threshold, pulse frequency between 8-13 Hz. TMS delivery of 5 second pulse train, with an inter-train interval of 20 seconds. Session duration is 15 minutes. A rest period of at least 30 minutes is required between the 2 sessions in a treatment day.

Device: EEG-based personalized TMS

Sham eTMS Treatment

SHAM COMPARATOR

15 treatment days of sham EEG-based personalized TMS over a maximum of 28 days. Two sessions per treatment day. Each session consists of sham TMS treatment. TMS delivery of 5 second pulse train, with an inter-train interval of 20 seconds. Session duration is 15 minutes. A rest period of at least 30 minutes is required between the 2 sessions in a treatment day.

Device: Sham Comparator

Interventions

EEG-based personalized TMS DEVICE

Transcranial Magnetic Stimulation (TMS), in which treatment is personalized based on the participant's Electroencephalogram (EEG)

Active eTMS treatment

Sham Comparator DEVICE

Sham Transcranial Magnetic Stimulation (TMS), in which treatment is personalized based on the participant's Electroencephalogram (EEG). No stimulation is provided.

Sham eTMS Treatment

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to consent to participate in the study via signed Informed Consent
• Age 22 - 65 years
• Diagnosis of PTSD according to DSM-5 criteria via the Clinician-Administered PTSD Scale (CAPS).
• Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms persisting for a minimum of 6 months prior to the Screening Visit
• Veterans Administration PCL-5 cut point score of 31 or above
• Positive identification as either a Veteran, or First Responder (e.g., emergency medical service provider, firefighter, or any other emergency response personnel)

You may not qualify if:

• Uncontrolled medical, psychological or neurological condition
• Pregnant, or female unwilling to use effective birth control during the course of the trial
• Metal objects in the head
• Past exposure to metal fragments, permanent piercings, and/or other possible metal sources in the head and neck
• Current participation in any interventional research protocol
• History of any type of Electroconvulsive Therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS)
• History of stroke or intracranial lesion or increased intracranial pressure
• History of epilepsy of seizure
• Family history of epilepsy or seizure in 1st degree relative
• An elevated risk of suicide or violence to others

Sponsors & Collaborators

• Wave Neuroscience: lead

Study Sites (2)

Wright State University

Dayton, Ohio, 45435, United States

RECRUITING

D2 Human Performance Center

Pickerington, Ohio, 45435, United States

RECRUITING

Related Publications (27)

• Bae EH, Schrader LM, Machii K, Alonso-Alonso M, Riviello JJ Jr, Pascual-Leone A, Rotenberg A. Safety and tolerability of repetitive transcranial magnetic stimulation in patients with epilepsy: a review of the literature. Epilepsy Behav. 2007 Jun;10(4):521-8. doi: 10.1016/j.yebeh.2007.03.004. Epub 2007 May 9.

  PMID: 17493877 BACKGROUND

• Bisson J, Andrew M. Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003388. doi: 10.1002/14651858.CD003388.pub3.

  PMID: 17636720 BACKGROUND

• Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26.

  PMID: 29726344 BACKGROUND

• Caulfield KA. Is accelerated, high-dose theta burst stimulation a panacea for treatment-resistant depression? J Neurophysiol. 2020 Jan 1;123(1):1-3. doi: 10.1152/jn.00537.2019. Epub 2019 Sep 25.

  PMID: 31553674 BACKGROUND

• Corlier J, Carpenter LL, Wilson AC, Tirrell E, Gobin AP, Kavanaugh B, Leuchter AF. The relationship between individual alpha peak frequency and clinical outcome with repetitive Transcranial Magnetic Stimulation (rTMS) treatment of Major Depressive Disorder (MDD). Brain Stimul. 2019 Nov-Dec;12(6):1572-1578. doi: 10.1016/j.brs.2019.07.018. Epub 2019 Jul 25.

  PMID: 31378603 BACKGROUND

• George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.

  PMID: 20439832 BACKGROUND

• George MS, Raman R, Benedek DM, Pelic CG, Grammer GG, Stokes KT, Schmidt M, Spiegel C, Dealmeida N, Beaver KL, Borckardt JJ, Sun X, Jain S, Stein MB. A two-site pilot randomized 3 day trial of high dose left prefrontal repetitive transcranial magnetic stimulation (rTMS) for suicidal inpatients. Brain Stimul. 2014 May-Jun;7(3):421-31. doi: 10.1016/j.brs.2014.03.006. Epub 2014 Mar 19.

  PMID: 24731434 BACKGROUND

• George MS, Wassermann EM, Williams WA, Steppel J, Pascual-Leone A, Basser P, Hallett M, Post RM. Changes in mood and hormone levels after rapid-rate transcranial magnetic stimulation (rTMS) of the prefrontal cortex. J Neuropsychiatry Clin Neurosci. 1996 Spring;8(2):172-80. doi: 10.1176/jnp.8.2.172.

  PMID: 9081553 BACKGROUND

• Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.

  PMID: 15664172 BACKGROUND

• Hunter AM, Minzenberg MJ, Cook IA, Krantz DE, Levitt JG, Rotstein NM, Chawla SA, Leuchter AF. Concomitant medication use and clinical outcome of repetitive Transcranial Magnetic Stimulation (rTMS) treatment of Major Depressive Disorder. Brain Behav. 2019 May;9(5):e01275. doi: 10.1002/brb3.1275. Epub 2019 Apr 2.

  PMID: 30941915 BACKGROUND

• Janicak PG, O'Reardon JP, Sampson SM, Husain MM, Lisanby SH, Rado JT, Heart KL, Demitrack MA. Transcranial magnetic stimulation in the treatment of major depressive disorder: a comprehensive summary of safety experience from acute exposure, extended exposure, and during reintroduction treatment. J Clin Psychiatry. 2008 Feb;69(2):222-32. doi: 10.4088/jcp.v69n0208.

  PMID: 18232722 BACKGROUND

• Jin Y, Phillips B. A pilot study of the use of EEG-based synchronized Transcranial Magnetic Stimulation (sTMS) for treatment of Major Depression. BMC Psychiatry. 2014 Jan 18;14:13. doi: 10.1186/1471-244X-14-13.

  PMID: 24438321 BACKGROUND

• Jin Y, Kemp AS, Huang Y, Thai TM, Liu Z, Xu W, He H, Potkin SG. Alpha EEG guided TMS in schizophrenia. Brain Stimul. 2012 Oct;5(4):560-8. doi: 10.1016/j.brs.2011.09.005. Epub 2011 Oct 6.

  PMID: 22019083 BACKGROUND

• Leuchter AF, Cook IA, Jin Y, Phillips B. The relationship between brain oscillatory activity and therapeutic effectiveness of transcranial magnetic stimulation in the treatment of major depressive disorder. Front Hum Neurosci. 2013 Feb 26;7:37. doi: 10.3389/fnhum.2013.00037. eCollection 2013.

  PMID: 23550274 BACKGROUND

• Loo CK, McFarquhar TF, Mitchell PB. A review of the safety of repetitive transcranial magnetic stimulation as a clinical treatment for depression. Int J Neuropsychopharmacol. 2008 Feb;11(1):131-47. doi: 10.1017/S1461145707007717. Epub 2007 Sep 20.

  PMID: 17880752 BACKGROUND

• Loo C, Sachdev P, Elsayed H, McDarmont B, Mitchell P, Wilkinson M, Parker G, Gandevia S. Effects of a 2- to 4-week course of repetitive transcranial magnetic stimulation (rTMS) on neuropsychologic functioning, electroencephalogram, and auditory threshold in depressed patients. Biol Psychiatry. 2001 Apr 1;49(7):615-23. doi: 10.1016/s0006-3223(00)00996-3.

  PMID: 11297719 BACKGROUND

• Machii K, Cohen D, Ramos-Estebanez C, Pascual-Leone A. Safety of rTMS to non-motor cortical areas in healthy participants and patients. Clin Neurophysiol. 2006 Feb;117(2):455-71. doi: 10.1016/j.clinph.2005.10.014. Epub 2006 Jan 4.

  PMID: 16387549 BACKGROUND

• O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14.

  PMID: 17573044 BACKGROUND

• Carpenter LL, Conelea C, Tyrka AR, Welch ES, Greenberg BD, Price LH, Niedzwiecki M, Yip AG, Barnes J, Philip NS. 5 Hz Repetitive transcranial magnetic stimulation for posttraumatic stress disorder comorbid with major depressive disorder. J Affect Disord. 2018 Aug 1;235:414-420. doi: 10.1016/j.jad.2018.04.009. Epub 2018 Apr 5.

  PMID: 29677606 BACKGROUND

• Roelofs CL, Krepel N, Corlier J, Carpenter LL, Fitzgerald PB, Daskalakis ZJ, Tendolkar I, Wilson A, Downar J, Bailey NW, Blumberger DM, Vila-Rodriguez F, Leuchter AF, Arns M. Individual alpha frequency proximity associated with repetitive transcranial magnetic stimulation outcome: An independent replication study from the ICON-DB consortium. Clin Neurophysiol. 2021 Feb;132(2):643-649. doi: 10.1016/j.clinph.2020.10.017. Epub 2020 Nov 10.

  PMID: 33243617 BACKGROUND

• Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24.

  PMID: 33243615 BACKGROUND

• Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.

  PMID: 19833552 BACKGROUND

• Sakkas P, Mihalopoulou P, Mourtzouhou P, Psarros C, Masdrakis V, Politis A, Christodoulou GN. Induction of mania by rTMS: report of two cases. Eur Psychiatry. 2003 Jun;18(4):196-8. doi: 10.1016/s0924-9338(03)00048-8.

  PMID: 12814856 BACKGROUND

• Wobrock T, Guse B, Cordes J, Wolwer W, Winterer G, Gaebel W, Langguth B, Landgrebe M, Eichhammer P, Frank E, Hajak G, Ohmann C, Verde PE, Rietschel M, Ahmed R, Honer WG, Malchow B, Schneider-Axmann T, Falkai P, Hasan A. Left prefrontal high-frequency repetitive transcranial magnetic stimulation for the treatment of schizophrenia with predominant negative symptoms: a sham-controlled, randomized multicenter trial. Biol Psychiatry. 2015 Jun 1;77(11):979-88. doi: 10.1016/j.biopsych.2014.10.009. Epub 2014 Oct 23.

  PMID: 25582269 BACKGROUND

• Yesavage JA, Fairchild JK, Mi Z, Biswas K, Davis-Karim A, Phibbs CS, Forman SD, Thase M, Williams LM, Etkin A, O'Hara R, Georgette G, Beale T, Huang GD, Noda A, George MS; VA Cooperative Studies Program Study Team. Effect of Repetitive Transcranial Magnetic Stimulation on Treatment-Resistant Major Depression in US Veterans: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Sep 1;75(9):884-893. doi: 10.1001/jamapsychiatry.2018.1483.

  PMID: 29955803 BACKGROUND

• Ziemann U. TMS and drugs. Clin Neurophysiol. 2004 Aug;115(8):1717-29. doi: 10.1016/j.clinph.2004.03.006.

  PMID: 15261850 BACKGROUND

• Ziemann U, Reis J, Schwenkreis P, Rosanova M, Strafella A, Badawy R, Muller-Dahlhaus F. TMS and drugs revisited 2014. Clin Neurophysiol. 2015 Oct;126(10):1847-68. doi: 10.1016/j.clinph.2014.08.028. Epub 2014 Dec 4.

  PMID: 25534482 BACKGROUND

Related Links

• Study Information Page

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Bill Phillips, PhD

  Wave Neuroscience, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Sherwood, PhD

CONTACT

937-775-2342; msherwood@etmsfda.com

Walter Mysiw, MD

CONTACT

614-293-3433; coordinator@etmsfda.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 24, 2025
• Study Start: February 12, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)