Transcranial Magnetic Stimulation (TMS) for Suicidal Ideation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
U.S. Army Medical Research and Materiel Command
Medical University of South Carolina
Ralph H. Johnson VA Medical Center
Walter Reed National Military Medical Center
University of California, San Diego
Information provided by (Responsible Party):
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
ClinicalTrials.gov Identifier:
NCT01212848
First received: September 29, 2010
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Depressive Episode
Posttraumatic Stress Disorder
Traumatic Brain Injury
Device: Transcranial Magnetic Stimulation
Device: Transcranial Magnetic Stimulation - Sham Comparator
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Safety and Feasibility Study of High Dose Left Prefrontal Transcranial Magnetic Stimulation (TMS) to Rapidly Stabilize Suicidal Patients With PTSD

Resource links provided by NLM:


Further study details as provided by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium:

Primary Outcome Measures:
  • Scale of Suicidal Ideation [ Time Frame: baseline to Day 3 of TMS treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability [ Time Frame: baseline through 6-month follow-up. ] [ Designated as safety issue: Yes ]
    -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 [ Time Frame: baseline through 6-month follow-up ] [ Designated as safety issue: Yes ]
    -length of current hospital stay along with Scale of Suicidal Ideation score, rehospitalization rates, and suicide completion rates over 6 months of follow-up


Enrollment: 42
Study Start Date: October 2010
Estimated Study Completion Date: October 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TMS Device: Transcranial 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.
Other Name: Neuronetics
Sham Comparator: Sham Device: Transcranial Magnetic Stimulation - Sham Comparator
The control group will receive an identical dosing schedule of "sham" repetitive TMS over three days.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212848

Locations
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
United States, South Carolina
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, United States, 29401
Sponsors and Collaborators
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
U.S. Army Medical Research and Materiel Command
Medical University of South Carolina
Ralph H. Johnson VA Medical Center
Walter Reed National Military Medical Center
University of California, San Diego
Investigators
Principal Investigator: Mark S George, MD Medical University of South Carolina
  More Information

No publications provided by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
ClinicalTrials.gov Identifier: NCT01212848     History of Changes
Other Study ID Numbers: INTRuST-TMS
Study First Received: September 29, 2010
Last Updated: April 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium:
Transcranial Magnetic Stimulation
Suicidal ideation

Additional relevant MeSH terms:
Brain Injuries
Depression
Depressive Disorder
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Suicidal Ideation
Anxiety Disorders
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Mental Disorders
Mood Disorders
Nervous System Diseases
Self-Injurious Behavior
Suicide
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 20, 2014