Overview

This trial is active, not recruiting.

Conditions depressive episode, posttraumatic stress disorder, traumatic brain injury
Treatments transcranial magnetic stimulation, transcranial magnetic stimulation - sham comparator
Phase phase 3
Sponsor INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Collaborator U.S. Army Medical Research and Materiel Command
Start date October 2010
End date March 2013
Trial size 42 participants
Trial identifier NCT01212848, INTRuST-TMS

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
transcranial magnetic stimulation Neuronetics
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 Comparator)
transcranial magnetic stimulation - sham comparator
The control group will receive an identical dosing schedule of "sham" repetitive TMS over three days.

Primary Outcomes

Measure
Scale of Suicidal Ideation
time frame: baseline to Day 3 of TMS treatment

Secondary Outcomes

Measure
Safety and tolerability
time frame: baseline through 6-month follow-up.
long-term efficacy of TMS
time frame: baseline through 6-month follow-up

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

Official title A Pilot Safety and Feasibility Study of High Dose Left Prefrontal Transcranial Magnetic Stimulation (TMS) to Rapidly Stabilize Suicidal Patients With PTSD
Principal investigator Mark S George, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium.