COMPLETED

Transcranial Magnetic Stimulation to Improve Functioning in Veterans With PTSD

Conditions

PTSD Transcranial Magnetic Stimulation Stress Disorders, Post-Traumatic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Transcranial Magnetic Stimulation to Improve Functioning in Veterans With PTSD

Quick Facts

Study Start:2020-12-01

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04207346

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age between 19 and 70 2. Moderate to severe PTSD as determined by the CAPS within 7 days of randomization. 3. Agree to have CAPS audio-recorded. 4. Ability to obtain a Motor Threshold using the TMS device during screening. 5. Patient eligible for VA healthcare. 6. If female with childbearing potential, use of acceptable method of birth control (i.e., use of contraceptives, abstinence). 7. Able to read, understand, and sign the informed consent document.	1. Pregnant or lactating woman. 2. Current use of clozapine (any dose) or bupropion (more than 300mg per day). 3. Cardiac pacemaker or implantable defibrillator. 4. Presence of any metal object in the head, including cochlear implants, but excluding dental work in the mouth. 5. Significant central nervous system disorder (stroke, brain mass, epilepsy). 6. Seizure in past one year. 7. Current psychosis or mania. 8. Prior use of TMS. 9. Significant suicidal ideation. 10. Unstable medical conditions. 11. Current alcohol or substance use disorder (except nicotine) that interferes with the patient's ability to participate. 12. CPT or PE for PTSD in the past 2 months. 13. Changes in Fluoxetine, Paroxetine, Sertraline, or Venlafaxine in the past 2 months.

Inclusion Criteria

Exclusion Criteria

1. Age between 19 and 70
2. Moderate to severe PTSD as determined by the CAPS within 7 days of randomization.
3. Agree to have CAPS audio-recorded.
4. Ability to obtain a Motor Threshold using the TMS device during screening.
5. Patient eligible for VA healthcare.
6. If female with childbearing potential, use of acceptable method of birth control (i.e., use of contraceptives, abstinence).
7. Able to read, understand, and sign the informed consent document.

1. Pregnant or lactating woman.
2. Current use of clozapine (any dose) or bupropion (more than 300mg per day).
3. Cardiac pacemaker or implantable defibrillator.
4. Presence of any metal object in the head, including cochlear implants, but excluding dental work in the mouth.
5. Significant central nervous system disorder (stroke, brain mass, epilepsy).
6. Seizure in past one year.
7. Current psychosis or mania.
8. Prior use of TMS.
9. Significant suicidal ideation.
10. Unstable medical conditions.
11. Current alcohol or substance use disorder (except nicotine) that interferes with the patient's ability to participate.
12. CPT or PE for PTSD in the past 2 months.
13. Changes in Fluoxetine, Paroxetine, Sertraline, or Venlafaxine in the past 2 months.

Contacts and Locations

Principal Investigator

Bradley V Watts, MD MPH

PRINCIPAL_INVESTIGATOR

White River Junction VA Medical Center, White River Junction, VT

Study Locations (Sites)

White River Junction VA Medical Center, White River Junction, VT

White River Junction, Vermont, 05001-3833

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Bradley V Watts, MD MPH, PRINCIPAL_INVESTIGATOR, White River Junction VA Medical Center, White River Junction, VT

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-01

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2020-12-01

Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

Transcranial Magnetic Stimulation
Stress Disorders, Post-Traumatic

Additional Relevant MeSH Terms

PTSD