Suicidal and Self-Injurious Behavior, Suicidal Depression, Suicidal Ideation, Suicidal Impulses, Suicidal Intention, Suicide
Conditions
Brief summary
The purpose of this study is to determine if the use of Transcranial Magnetic Stimulation (TMS) provides rapid reduction and sustained attenuation of suicidal crisis. TMS is a treatment for suicidal crisis that is quicker, less invasive, better tolerated, and with fewer side effects than current treatments such as Electroconvulsive Therapy (ECT) and medication therapies. There will be 6 months of follow-up, in order to establish the ongoing and lasting therapeutic effect of TMS.
Detailed description
The programmatic-level objective of the study is to address the goals of the Army STARRS Program and the Suicide Prevention for America's Veterans Act through implementation of an effective acute treatment for patients psychiatrically admitted in suicidal crisis as well as other patients at high-risk for suicide. This is achieved by application of TMS, which provides a treatment for suicidal crisis that is quicker, less invasive, better tolerated, and with fewer side effects and less incapacitation than current treatments such as ECT and pharmacologic therapies. A recent study led by the senior consultant of this proposal demonstrated tolerance and efficacy for a new, high-dose regimen of TMS in a VA population with an average age of 47. The objective of the proposed study is to extend the application of TMS to a younger population of Active Duty Service Members (SM) in order to demonstrate efficacy for returning veterans of the Middle East wars, in particular, as well as the civilian young adult population. TMS dosage in the proposed study is recalibrated to commercially-standard levels in order to provide consistency with devices currently in clinical operation. In addition, follow-up in the proposed study continues for 6 months in order to establish persistence and durability of the therapeutic effect of TMS.
Interventions
DEVICENeuronetics NeuroStar XPLOR magnetic stimulator - Active
Localization: Left prefrontal dorsolateral neocortex. Dose Delivery: Figure-8 solid core coil at 120% motor threshold, 10 Hz, 4 second train duration, 10 second interval for 30 minutes. Treatment Dose: \ 4k/session, 12-15k/day, 36-45k total pulses. Sessions: 9 in total; 3/day for 3 consecutive days over and above SOC.
DEVICENeuronetics NeuroStar XPLOR magnetic stimulator - Sham
Localization: Left prefrontal dorsolateral neocortex. Sham Delivery: Figure-8 solid core coil rendered inert via blocking insert. Dose: Zero pulses. Sessions: 9 in total; 3/day for 3 consecutive days over and above SOC.
Sponsors
Congressionally Directed Medical Research Programs
Augusta University
The Geneva Foundation
Eisenhower Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* All Active Duty SMs (regardless of sex, ethnicity, sexual or religious orientation) who are admitted to Eisenhower Army Medical Center (EAMC) Inpatient Psychiatric Service (IPS) with active suicidality or elevated risk for suicide regardless of most psychiatric diagnostic co-morbidity (see
Exclusion criteria
). This includes in-patient admissions for suicidality and outpatient SMs with a Columbia-Suicide Severity Rating Scale (C-SSRS) score ≥3. * Age 18 to 60 * Able to speak and read English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Suicidal Ideation (Acute) | Change over the active treatment course ie. the 3 days of active treatment | The Beck Scale for Suicidal Ideation (SSI-T) is a 19-item clinician administered scale measuring current suicide ideation (SSI-C), suicide ideation at its worst point in the patient's life (SSI-W), and degree of hopelessness. The scale has been well validated. SSI-T scores range from 0-38, with higher scores indicating greater suicide risk. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TMSactive TMSactive | 59 |
| TMSsham TMSsham | 61 |
| Total | 120 |
Baseline characteristics
| Characteristic | TMSactive | TMSsham | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 59 Participants | 61 Participants | 120 Participants |
| Age, Continuous | 28.3 years STANDARD_DEVIATION 6.9 | 26.5 years STANDARD_DEVIATION 6.4 | 27.4 years STANDARD_DEVIATION 6.7 |
| Race/Ethnicity, Customized demographic black | 8 Participants | 13 Participants | 21 Participants |
| Race/Ethnicity, Customized demographic hispanic | 10 Participants | 5 Participants | 15 Participants |
| Race/Ethnicity, Customized demographic other | 6 Participants | 4 Participants | 10 Participants |
| Race/Ethnicity, Customized demographic white | 35 Participants | 39 Participants | 74 Participants |
| Region of Enrollment United States | 59 participants | 61 participants | 120 participants |
| Sex: Female, Male Female | 15 Participants | 19 Participants | 34 Participants |
| Sex: Female, Male Male | 44 Participants | 42 Participants | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 61 |
| other Total, other adverse events | 18 / 59 | 7 / 61 |
| serious Total, serious adverse events | 2 / 59 | 2 / 61 |
Outcome results
Primary
Change in Suicidal Ideation (Acute)
The Beck Scale for Suicidal Ideation (SSI-T) is a 19-item clinician administered scale measuring current suicide ideation (SSI-C), suicide ideation at its worst point in the patient's life (SSI-W), and degree of hopelessness. The scale has been well validated. SSI-T scores range from 0-38, with higher scores indicating greater suicide risk.
Time frame: Change over the active treatment course ie. the 3 days of active treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TMS Active | Change in Suicidal Ideation (Acute) | 0.12 score on a scale | Standard Error 0.06 |
| TMSsham | Change in Suicidal Ideation (Acute) | 0.12 score on a scale | Standard Error 0.06 |