Depressive Episode, Posttraumatic Stress Disorder, Traumatic Brain Injury
Conditions
Keywords
Transcranial Magnetic Stimulation, Suicidal ideation
Brief summary
The purpose of this study is to determine whether transcranial magnetic stimulation (TMS) is effective in the treatment of suicidal thinking in individuals with a depressive episode and either posttraumatic stress disorder (PTSD), history of mild traumatic brain injury (TBI), or both conditions.
Detailed description
Evidence suggests that depression in general, and suicidal ideation in particular, results from a dysfunctional regulatory pathway involving prefrontal cortical governance over limbic activity. Repeated daily non-invasive stimulation of the prefrontal cortex with TMS would theoretically strengthen and reset this cortical control pathway and reduce suicidal ideation and restore healthy circuit behavior. The aim of the current study is to assess the efficacy of TMS therapy in the treatment of suicidal ideation in patients with depressive episode(s) and either PTSD or mild TBI or both. It is hypothesized that participants who receive repetitive TMS (Group 1) relative to sham treatment (Group 2) three times daily over three days will evidence more improvement in suicidal ideation from baseline to the end of day 3. Participants will be followed for six months following treatment to assess safety and long-term efficacy of TMS.
Interventions
DEVICETranscranial Magnetic Stimulation
Group 1: The treatment group will receive the following dose of repetitive TMS delivered over the left prefrontal cortex: 10 Hz, 120% Motor Threshold, 5 second pulse train, 10 second intertrain (IT) interval, 30 minutes of treatment, 6000 pulses per session; three sessions each day (18,000 stimuli) for three days for a total of 54,000 stimuli.
DEVICETranscranial Magnetic Stimulation - Sham Comparator
The control group will receive an identical dosing schedule of sham repetitive TMS over three days.
Sponsors
U.S. Army Medical Research and Development Command
Medical University of South Carolina
Ralph H. Johnson VA Medical Center
Walter Reed National Military Medical Center
University of California, San Diego
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Veteran inpatients aged 18-70 years inclusive, with a depressive episode. 2. Must also have either or both 1. a diagnosis of PTSD as defined by DSM-IV supported by the SCID, or 2. a diagnosis of mild TBI, either complicated (i.e., with imaging abnormalities) or uncomplicated, as defined by INTRuST criteria. The American Congress of Rehabilitation Medicine (ACRM) definition of mild TBI will be utilized for this study (Kay et al., 1993). That definition will be operationalized using the INTRuST Screening Instrument. 3. Admitted because of suicidal ideation. 4. SSI score \> 12. 5. HRSD question #3 \> 3. 6. Female subjects of childbearing potential must have a negative urine pregnancy test. 7. Comorbid (non-principal) diagnoses of psychiatric disorders not explicitly listed in the following
Exclusion criteria
section are generally permitted (with final eligibility determination by Site Principal Investigator clinical assessment). 8. Subjects must be able to speak English and complete study forms, adhere to treatment regimens, and be willing to return for regular visits. 9. After full explanation of the study, subjects must demonstrate their willingness to participate by signing the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scale of Suicidal Ideation | baseline to Day 3 of TMS treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | baseline through 6-month follow-up. | -adverse events, study study discontinuation due to adverse events, & decrease in cognitive function as measured by significant change on neuropsychological measures |
| long-term efficacy of TMS | baseline through 6-month follow-up | -length of current hospital stay along with Scale of Suicidal Ideation score, rehospitalization rates, and suicide completion rates over 6 months of follow-up |
Countries
United States
Outcome results
None listed