Transcranial Magnetic Stimulation to Improve Functioning in Veterans With PTSD

Overview

Posttraumatic Stress Disorder (PTSD) is a common and serious condition affecting many Veterans. There are effective treatments for PTSD, but additional treatments are needed in order to better serve Veterans suffering from PTSD. Transcranial magnetic stimulation is one such promising treatment. It involves use of powerful magnet to stimulate the specific brain regions in Veterans with PTSD. Transcranial magnetic stimulation has been shown effective in treating depression, but currently it is unclear if it is an effective treatment for PTSD. This is a randomized clinical trial enrolling 91 Veterans with PTSD comparing the effectiveness of transcranial magnetic stimulation treatment and sham transcranial magnetic stimulation in treating PTSD. The hypothesis is that those who receive transcranial magnetic stimulation will experience improved functioning.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 30, 2023

Detailed Description

Background Posttraumatic Stress Disorder (PTSD) is an often chronic and disabling condition prevalent in the Veteran population. While there is sufficient evidence to demonstrate the effectiveness of medications and psychotherapy for improving PTSD symptoms, there has been limited study of functioning as an outcome, and the role of other treatments such as somatic therapies. One promising but understudied somatic treatment for PTSD is repetitive transcranial magnetic stimulation (TMS). The characteristics of TMS treatment are different than those of existing treatments and may provide alternative treatment to Veterans who do not respond to medications and psychotherapy. Further, it is possible that TMS may have a greater effect on functioning and lead to higher rates of recovery compared with medications or psychotherapy.

Objective To determine whether Veteran participants with PTSD who receive TMS delivered to the right dorsolateral prefrontal cortex at 1 Hz have greater improvements in: PTSD symptoms, functioning, and depressive symptoms than Veterans receiving sham treatments at treatment completion and at 3 and 6 months after treatment completion.

Method 91 Veterans with PTSD will be randomly assigned to receive low frequency TMS or sham TMS. All TMS will be applied to the right dorsolateral prefrontal cortex. PTSD symptoms, functional outcomes, and depressive symptoms will be measured for all participants at treatment completion, 3 months, and 6 months after completion.

Hypothesis Veterans with PTSD receiving TMS will have greater improvements in PTSD symptoms, functioning, and depressive symptoms at treatment completion and at three and six months after treatment completion compared to Veterans receiving sham TMS.

Interventions

  • Device: TMS 1 hz
    • High-performance magnetic stimulator designed for clinical use or use in clinical trials. This specific device has a coil designed with one side that delivers active treatment and the other side that delivers sham (no stimulation) treatment. The sham side is externally identical to the active side, but internally it has a shield that prevents any magnetic energy from interacting with the patient. This arm will use the active side.
  • Device: Sham TMS
    • High-performance magnetic stimulator designed for clinical use or use in clinical trials. This specific device has a coil designed with one side that delivers active treatment and the other side that delivers sham (no stimulation) treatment. The sham side is externally identical to the active side, but internally it has a shield that prevents any magnetic energy from interacting with the patient. This arm will use the sham side.

Arms, Groups and Cohorts

  • Experimental: TMS
    • transcranial magnetic stimulation delivered to the right dorsolateral prefrontal cortex at 1 Hz
  • Sham Comparator: Sham
    • sham transcranial magnetic stimulation delivered to the right dorsolateral prefrontal cortex

Clinical Trial Outcome Measures

Primary Measures

  • CAPS
    • Time Frame: Baseline
    • The Clinician-administered scale of PTSD symptoms (CAPS) queries the frequency and intensity of symptoms of PTSD. The score ranges from 0-80 with a higher score indicating worse symptoms. It is considered the gold standard for diagnosis and symptoms assessment in PTSD clinical studies.
  • WHODAS
    • Time Frame: Baseline
    • The World Health Organization Disability Assessment Schedule 2.0 (WHODAS) is a 36 item self-report instrument that assesses disability and function across six domains: communicating, getting around, self-care, getting along with people, life activities, and participation in society. The WHODAS has been used as an outcome of function and disability across many disorders and is commonly used in mental health treatment trials. The total score ranges from 0-100 with a higher score indicating worse functioning.
  • IDS-C30
    • Time Frame: Baseline
    • The Inventory of Depressive Symptomatology (IDS-C30) is a 30-item clinician administered assessment of depressive symptoms. The IDS includes nine domains that relate to the nine primary symptoms of major depressive disorder in the DSM-V. The score ranges from 0-90 with a higher score indicating worse depression.
  • CAPS
    • Time Frame: 2 weeks
    • The Clinician-administered scale of PTSD symptoms (CAPS) queries the frequency and intensity of symptoms of PTSD. The score ranges from 0-80 with a higher score indicating worse symptoms. It is considered the gold standard for diagnosis and symptoms assessment in PTSD clinical studies.
  • CAPS
    • Time Frame: 3 months
    • The Clinician-administered scale of PTSD symptoms (CAPS) queries the frequency and intensity of symptoms of PTSD. The score ranges from 0-80 with a higher score indicating worse symptoms. It is considered the gold standard for diagnosis and symptoms assessment in PTSD clinical studies.
  • CAPS
    • Time Frame: 6 months
    • The Clinician-administered scale of PTSD symptoms (CAPS) queries the frequency and intensity of symptoms of PTSD. The score ranges from 0-80 with a higher score indicating worse symptoms. It is considered the gold standard for diagnosis and symptoms assessment in PTSD clinical studies.
  • WHODAS
    • Time Frame: 2 weeks
    • The World Health Organization Disability Assessment Schedule 2.0 (WHODAS) is a 36 item self-report instrument that assesses disability and function across six domains: communicating, getting around, self-care, getting along with people, life activities, and participation in society. The WHODAS has been used as an outcome of function and disability across many disorders and is commonly used in mental health treatment trials. The total score ranges from 0-100 with a higher score indicating worse functioning.
  • WHODAS
    • Time Frame: 3 months
    • The World Health Organization Disability Assessment Schedule 2.0 (WHODAS) is a 36 item self-report instrument that assesses disability and function across six domains: communicating, getting around, self-care, getting along with people, life activities, and participation in society. The WHODAS has been used as an outcome of function and disability across many disorders and is commonly used in mental health treatment trials. The total score ranges from 0-100 with a higher score indicating worse functioning.
  • WHODAS
    • Time Frame: 6 months
    • The World Health Organization Disability Assessment Schedule 2.0 (WHODAS) is a 36 item self-report instrument that assesses disability and function across six domains: communicating, getting around, self-care, getting along with people, life activities, and participation in society. The WHODAS has been used as an outcome of function and disability across many disorders and is commonly used in mental health treatment trials. The total score ranges from 0-100 with a higher score indicating worse functioning.
  • IDS-C30
    • Time Frame: 2 weeks
    • The Inventory of Depressive Symptomatology (IDS-C30) is a 30-item clinician administered assessment of depressive symptoms. The IDS includes nine domains that relate to the nine primary symptoms of major depressive disorder in the DSM-V. The score ranges from 0-90 with a higher score indicating worse depression.
  • IDS-C30
    • Time Frame: 3 months
    • The Inventory of Depressive Symptomatology (IDS-C30) is a 30-item clinician administered assessment of depressive symptoms. The IDS includes nine domains that relate to the nine primary symptoms of major depressive disorder in the DSM-V. The score ranges from 0-90 with a higher score indicating worse depression.
  • IDS-C30
    • Time Frame: 6 months
    • The Inventory of Depressive Symptomatology (IDS-C30) is a 30-item clinician administered assessment of depressive symptoms. The IDS includes nine domains that relate to the nine primary symptoms of major depressive disorder in the DSM-V. The score ranges from 0-90 with a higher score indicating worse depression

Participating in This Clinical Trial

Inclusion Criteria

  • Veteran receiving care at the White River Junction VA Medical Center
  • Current diagnosis of PTSD with moderate to severe symptoms by DSM-V criteria as defined by the CAPS (total score 38 or greater)
  • Capable of signing informed consent

Exclusion Criteria

  • Current psychosis, mania, or significant suicidal ideation, as well as active alcohol or substance use disorder (except nicotine) in the past 3 months
  • Having received a previous trial of TMS
  • Evidence of significant cognitive impairment observed or found in the medical record
  • The following exclusions are related to the safety of TMS because of risk of seizures risk or magnetic interaction with metallic objects:
  • metal object in head, scalp, or neck
  • implantable medical devices including cardiac pacemakers and defibrillators
  • seizure within the last year
  • acute medical illness
  • investigators unable to determine motor threshold
  • any significant central nervous system disorders such as brain mass, stroke, or epilepsy
  • currently taking clozapine or bupropion (which are known to affect seizure threshold)

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • VA Office of Research and Development
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bradley V Watts, MD MPH, Principal Investigator, White River Junction VA Medical Center, White River Junction, VT
  • Overall Contact(s)
    • Bradley V Watts, MD MPH, (802) 295-9363, Bradley.Watts@va.gov

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