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Transcranial Magnetic Stimulation (TMS) for Suicidal Ideation

Primary Purpose

Depressive Episode, Posttraumatic Stress Disorder, Traumatic Brain Injury

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation - Sham Comparator
Sponsored by
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Episode focused on measuring Transcranial Magnetic Stimulation, Suicidal ideation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Walter Reed National Military Medical Center
  • Ralph H. Johnson VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

TMS

Sham

Arm Description

Outcomes

Primary Outcome Measures

Scale of Suicidal Ideation

Secondary Outcome Measures

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

Full Information

First Posted
September 29, 2010
Last Updated
April 24, 2013
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
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1. Study Identification

Unique Protocol Identification Number
NCT01212848
Brief Title
Transcranial Magnetic Stimulation (TMS) for Suicidal Ideation
Official Title
A Pilot Safety and Feasibility Study of High Dose Left Prefrontal Transcranial Magnetic Stimulation (TMS) to Rapidly Stabilize Suicidal Patients With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
October 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Episode, Posttraumatic Stress Disorder, Traumatic Brain Injury
Keywords
Transcranial Magnetic Stimulation, Suicidal ideation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TMS
Arm Type
Experimental
Arm Title
Sham
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Other Intervention Name(s)
Neuronetics
Intervention Description
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
Intervention Name(s)
Transcranial Magnetic Stimulation - Sham Comparator
Intervention Description
The control group will receive an identical dosing schedule of "sham" repetitive TMS over three days.
Primary Outcome Measure Information:
Title
Scale of Suicidal Ideation
Time Frame
baseline to Day 3 of TMS treatment
Secondary Outcome Measure Information:
Title
Safety and tolerability
Description
-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.
Title
long-term efficacy of TMS
Description
-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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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). 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark S George, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
Ralph H. Johnson VA Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24731434
Citation
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.
Results Reference
derived

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Transcranial Magnetic Stimulation (TMS) for Suicidal Ideation

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