Transcranial Magnetic Stimulation (TMS) for Suicidal Ideation

NCT ID: NCT01212848

Last Updated: 2013-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-10-31

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.

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.

Conditions

Depressive Episode; Posttraumatic Stress Disorder; Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

TMS

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type: 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.

Sham

Group Type: SHAM_COMPARATOR

Transcranial Magnetic Stimulation - Sham Comparator

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Transcranial Magnetic Stimulation - Sham Comparator

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

Intervention Type: DEVICE

Other Intervention Names

Neuronetics

Eligibility 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.

Exclusion Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

Ralph H. Johnson VA Medical Center

FED

Sponsor Role: collaborator

Walter Reed National Military Medical Center

FED

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: collaborator

INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark S George, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24731434 (View on PubMed)

Other Identifiers

INTRuST-TMS

Identifier Type: -

Identifier Source: org_study_id