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Status unknownNCT01212848Updated Apr 26, 2013

Transcranial Magnetic Stimulation (TMS) for Suicidal Ideation

A Phase 3 interventional study of Transcranial Magnetic Stimulation and Transcranial Magnetic Stimulation - Sham Comparator in Depressive Episode, Posttraumatic Stress Disorder and Traumatic Brain Injury, sponsored by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium. Status unknown at 2 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-04-26.

Sponsored by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2013), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Depressive Episode
  • Posttraumatic Stress Disorder
  • Traumatic Brain Injury

Keywords

  • Transcranial Magnetic Stimulation
  • Suicidal ideation
03

In context

Brain Injuries

2,112 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.

This study's enrollment of 42 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts 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.

Exclusion criteria

Exclusion Criteria:

  1. Subjects who have clinically unstable medical disease (cardiovascular, renal, gastrointestinal, pulmonary, metabolic, endocrine, other); CNS disease deemed progressive; moderate or severe traumatic brain injury (TBI). Patients with mild TBI, however, will not be excluded from study participation. The ACRM definition of mild TBI will be utilized for this study (Kay et al., 1993). That definition will be operationalized using the INTRuST TBI Screening Instrument.
  2. Females who are pregnant or currently breast feeding.
  3. Current or history of schizophrenia or other psychotic disorder (except psychosis NOS when the presence of sensory hallucinations are clearly related to the subject's trauma), bipolar Type I disorder, or dementia (vascular, Alzheimer's disease, other types). Patients with bipolar Type II disorder will not be excluded.
  4. Subjects who repeatedly abused or were dependent upon drugs (excluding nicotine and caffeine) within 6 days of study entry will be excluded, (with the exception of alcohol abuse which, at the discretion of the primary site investigator, may be permitted*).
  5. Subjects actively participating (or planning to enroll) in an evidence-based exposure/cognitive treatment for PTSD during the trial, or who have been enrolled in one during the past 6 weeks; participation in other psychotherapeutic modalities must have been stable for 3 months prior to enrollment and remain stable throughout participation.
  6. Subjects currently taking medications that have short half-lives, lower the seizure threshold, and do not have evidence of antidepressant efficacy. These include high dose theophylline, or stimulants such as methylphenidate. Patients taking buproprion have to be on a stable dose and take less than or equal to 300 mg/day. Stable means the same dose for 5 half-lives.
  7. Subjects with metal in their head (other than dental implants), implanted devices in their head (shunts, cochlear implants).
  8. Subjects with a history of seizures or a seizure disorder.
  9. Subjects with borderline personality disorder or who have clear evidence of secondary gain as a reason for admission.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    TMS

    Device: Transcranial Magnetic Stimulation

  • Sham comparator
    Sham

    Device: Transcranial Magnetic Stimulation - Sham Comparator

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.

    Also known as: Neuronetics

  • DeviceTranscranial Magnetic Stimulation - Sham Comparator

    The control group will receive an identical dosing schedule of "sham" repetitive TMS over three days.

06

What researchers measure

Primary outcomes

  1. Scale of Suicidal Ideation

    Time frame: baseline to Day 3 of TMS treatment

Secondary outcomes

  1. Safety and tolerability

    -adverse events, study study discontinuation due to adverse events, \& decrease in cognitive function as measured by significant change on neuropsychological measures

    Time frame: baseline through 6-month follow-up.

  2. long-term efficacy of TMS

    -length of current hospital stay along with Scale of Suicidal Ideation score, rehospitalization rates, and suicide completion rates over 6 months of follow-up

    Time frame: baseline through 6-month follow-up

07

Study locations

2 sites
  • Walter Reed National Military Medical Center
    Bethesda, Maryland 20889, United States
  • Ralph H. Johnson VA Medical Center
    Charleston, South Carolina 29401, United States
08

References and documents

Publications

  • George MS, Raman R, Benedek DM, Pelic CG, Grammer GG, Stokes KT, Schmidt M, Spiegel C, Dealmeida N, Beaver KL, Borckardt JJ, Sun X, Jain S, Stein MB. A two-site pilot randomized 3 day trial of high dose left prefrontal repetitive transcranial magnetic stimulation (rTMS) for suicidal inpatients. Brain Stimul. 2014 May-Jun;7(3):421-31. doi: 10.1016/j.brs.2014.03.006. Epub 2014 Mar 19. PubMed 24731434 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01212848
Lead sponsor
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Collaborators
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
Responsible party
Sponsor
First posted
Oct 1, 2010
Start date
Oct 2010
Primary completion
Mar 2013
Completion
Oct 2013 (estimated)
Last update
Apr 26, 2013

Study contacts

Mark S George, MD
principal investigator · Medical University of South Carolina

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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