SuicideTMS4SINCT03014362
TMS for Suicidal Crisis in Active Duty SMs
A study testing Neuronetics NeuroStar XPLOR magnetic stimulator - Active in people with Suicide and Suicidal Ideation, run by Eisenhower Army Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Suicide, Suicidal Ideation, Suicidal Impulses
- What is being tested?
- Neuronetics NeuroStar XPLOR magnetic stimulator - Active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2017to 10 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Combative with staff.
- Comatose/catatonia.
- Incapacity owing to active mania or psychosis.
- Epilepsy, multiple sclerosis, or cerebrovascular accident.
- Non-removable metal in the head (Shrapnel; plates, aneurysm coils/clips; metal tattoos etc.)
- Implantable devices (pacemakers, stimulators, etc.)
Show all 10Show fewer
- Schizophrenic or borderline personality.
- Positive screen for pregnancy.
- Already receiving TMS as a treatment for depression.
- Non-English reading and speaking subjects
Trial locations and contacts
1 site in 1 country.
United States1 site
Eisenhower Army Medical Center
Augusta, Georgia, 30905
About this study
Official title: Utility of Repetitive Transcranial Magnetic Stimulation (TMS) in Promoting Rapid Psychiatric Stabilization in Acutely Suicidal Military Service Members
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.
Read the 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.
- Conditions
- Suicide, Suicidal Ideation, Suicidal Impulses, Suicidal Intention, Suicidal and Self-Injurious Behavior, Suicidal Depression
- Being tested
- Neuronetics NeuroStar XPLOR magnetic stimulator - Active, Neuronetics NeuroStar XPLOR magnetic stimulator - Sham
- Medical subject headings
- Suicide, Suicidal Ideation, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuronetics NeuroStar XPLOR magnetic stimulator - ActiveDevice
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.
Neuronetics NeuroStar XPLOR magnetic stimulator - ShamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TMS active | Active comparator | Neuronetics 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 (Standard of Care). Receives: Device: Neuronetics NeuroStar XPLOR magnetic stimulator - Active |
| TMS sham | Sham comparator | Neuronetics 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. Receives: Device: Neuronetics NeuroStar XPLOR magnetic stimulator - Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change over the active treatment course ie. the 3 days of active treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study start12 Jun 2017
- Primary completion10 Jan 2020
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisenhower Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Congressionally Directed Medical Research Programs, Augusta University, The Geneva Foundation
- Responsible party
- Principal investigator, Christopher Hines, Eisenhower Army Medical Center
- Investigators
- Christopher E Hines, MD, Principal investigator, Eisenhower Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014362
- Sponsor's protocol ID
- 1604023
- Acronym
- TMS4SI
- Status last verified
- Sep 2022
- First submitted
- 30 Nov 2016
- Last updated
- 28 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hines CE, Mooney S, Watson NL, Looney SW, Wilkie DJ. Repetitive Transcranial Magnetic Stimulation Promotes Rapid Psychiatric Stabilization in Acutely Suicidal Military Service Members. J ECT. 2022 Jun 1;38(2):103-109. doi: 10.1097/YCT.0000000000000810.
PubMed 35613009
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Repetitive Transcranial Magnetic Stimulation (TMS) in Promoting Rapid Psychiatric Stabilization in Acutely Suicidal Military Service Members
- ClinicalTrials.gov ID
- NCT03014362
- Acronym / sponsor ID
- TMS4SI / 1604023
- Conditions
- Suicide, Suicidal Ideation, Suicidal Impulses, Suicidal Intention, Suicidal and Self-Injurious Behavior, Suicidal Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Eisenhower Army Medical CenterUS federal agency
- Collaborators
- Congressionally Directed Medical Research Programs, Augusta University, The Geneva Foundation
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Posted 28 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMS active | Active comparator | Device: Neuronetics NeuroStar XPLOR magnetic stimulator - ActiveNeuronetics 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 (Standard of Care). |
| TMS sham | Sham comparator | Device: Neuronetics NeuroStar XPLOR magnetic stimulator - ShamNeuronetics 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- Combative with staff.
- Comatose/catatonia.
- Incapacity owing to active mania or psychosis.
- Epilepsy, multiple sclerosis, or cerebrovascular accident.
- Non-removable metal in the head (Shrapnel; plates, aneurysm coils/clips; metal tattoos etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuronetics NeuroStar XPLOR magnetic stimulator - ActiveLocalization: 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. | Device | TMS active |
| Neuronetics NeuroStar XPLOR magnetic stimulator - ShamLocalization: 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. | Device | TMS sham |
Primary outcome
Change in Suicidal Ideation (Acute)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35613009Hines CE, Mooney S, Watson NL, Looney SW, Wilkie DJ. Repetitive Transcranial Magnetic Stimulation Promotes Rapid Psychiatric Stabilization in Acutely Suicidal Military Service Members. J ECT. 2022 Jun 1;38(2):103-109. doi: 10.1097/YCT.0000000000000810.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher E Hines, MD principal investigator
Eisenhower Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuronetics NeuroStar XPLOR magnetic stimulator - Active in people with Suicide and Suicidal Ideation, run by Eisenhower Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Suicidal Ideation (Acute) (time frame: Change over the active treatment course ie. the 3 days of active treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03014362, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.