Transcranial Magnetic Stimulation (TMS) for Suicidal Ideation

NCT01212848 | Unknown Phase 3 DMC

• 1 other identifier: INTRuST-TMS
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Depressive Episode; Posttraumatic Stress Disorder; Traumatic Brain Injury

Keywords

Transcranial Magnetic Stimulation; Suicidal ideation

Outcome Measures

Primary Outcomes (1)

• Scale of Suicidal Ideation

  baseline to Day 3 of TMS treatment

Secondary Outcomes (2)

• Safety and tolerability

  baseline through 6-month follow-up.

• long-term efficacy of TMS

  baseline through 6-month follow-up

Study Arms (2)

TMS

EXPERIMENTAL

Device: Transcranial Magnetic Stimulation

Sham

SHAM COMPARATOR

Device: Transcranial Magnetic Stimulation - Sham Comparator

Interventions

Transcranial Magnetic Stimulation DEVICE

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

TMS

Transcranial Magnetic Stimulation - Sham Comparator DEVICE

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

Sham

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran inpatients aged 18-70 years inclusive, with a depressive episode.
• Must also have either or both
• a diagnosis of PTSD as defined by DSM-IV supported by the SCID, or
• 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.
• Admitted because of suicidal ideation.
• SSI score \> 12.
• HRSD question #3 \> 3.
• Female subjects of childbearing potential must have a negative urine pregnancy test.

You may not qualify if:

• Subjects must be able to speak English and complete study forms, adhere to treatment regimens, and be willing to return for regular visits.
• After full explanation of the study, subjects must demonstrate their willingness to participate by signing the informed consent form.
• 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.
• Females who are pregnant or currently breast feeding.
• 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.
• 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\*).
• 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.
• 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.
• Subjects with metal in their head (other than dental implants), implanted devices in their head (shunts, cochlear implants).
• Subjects with a history of seizures or a seizure disorder.
• Subjects with borderline personality disorder or who have clear evidence of secondary gain as a reason for admission.

Sponsors & Collaborators

• INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium: lead
• U.S. Army Medical Research and Development Command: collaborator
• Medical University of South Carolina: collaborator
• Ralph H. Johnson VA Medical Center: collaborator
• Walter Reed National Military Medical Center: collaborator
• University of California, San Diego: collaborator

Study Sites (2)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, 29401, United States

Location

Related Publications (1)

• 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.

  PMID: 24731434 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic; Suicidal Ideation

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Mark S George, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: October 1, 2010
• Study Start: October 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: October 1, 2013
• Last Updated: April 26, 2013

Record last verified: 2013-04

Locations

US (2)