Clinical trial NCT04207346: Transcranial Magnetic Stimulation to Improve Functioning in Veterans With PTSD
Official title: Transcranial Magnetic Stimulation to Improve Functioning in Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Keywords: Transcranial Magnetic Stimulation
Stress Disorders, Post-Traumatic
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-12-20
Enrollment: 91
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two or more groups in parallel for the duration of the study: procedure vs. sham procedure
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: CAPS
timeFrame: Baseline
measure: WHODAS
timeFrame: Baseline
measure: QIDS SR-16
timeFrame: Baseline
measure: CAPS
timeFrame: 2 weeks
measure: CAPS
timeFrame: 3 months
measure: CAPS
timeFrame: 6 months
measure: WHODAS
timeFrame: 2 weeks
measure: WHODAS
timeFrame: 3 months
measure: WHODAS
timeFrame: 6 months
measure: QIDS SR-16
timeFrame: 2 weeks
measure: QIDS SR-16
timeFrame: 3 months
measure: QIDS SR-16
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: White River Junction
country: United States
facility: White River Junction VA Medical Center, White River Junction, VT
state: Vermont
Study officials:
affiliation: White River Junction VA Medical Center, White River Junction, VT
name: Bradley V Watts, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: