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Repetitive Transcranial Magnetic Stimulation as Treatment for Acute Suicidality in Adult Patients (rTMS)

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ClinicalTrials.gov Identifier: NCT02693743
Recruitment Status : Completed
First Posted : February 29, 2016
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
Suicide was responsible for almost 40,000 deaths in 2011 in America. It is still singularly difficult to predict who is going to commit suicide and how to establish adequate interventions. Growing evidence supports the view that suicide is associated with poor decision making. Suicide is hypothesized to be triggered by stressful situations that create overwhelming psychological pain in an individual who chooses to terminate his/her own life, disregarding all future consequences. We have previously demonstrated rewarding impulsive choice common to both recent suicide attempters and suicidal depressed patients (1). Consistent with these findings, we hypothesize that high frequency repetitive transcranial magnetic stimulation (rTMS) of the left prefrontal cortex will improve impulsive response tendencies as measured by the delay discounting procedure, and this in turn will be associated with a faster resolution of suicidal ideation. To these effects we will be using a randomized control trial of rTMS in adult inpatients at the Psychiatric Research Institute (PRI) hospitalized for acute suicidality. At the conclusion of these studies, we will have tested the value of decision making in the development of suicide ideation and behavior, as well as piloted the use of rTMS in the treatment of these patients.

Condition or disease Intervention/treatment Phase
Suicidal Ideation Device: repetitive transcranial magnetic stimulation (rTMS) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation as Treatment for Acute Suicidality in Adult Patients
Actual Study Start Date : May 22, 2017
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Active Comparator: Active rTMS
Repetitive Transcranial Magnetic Stimulation (rTMS) will be delivered to the left PFC, defined as a location 6 cm (cm) anterior to the right hand motor thumb area. A research nurse will deliver the treatments. rTMS will be delivered with a figure-eight coil at 120% motor threshold, 10 Hertz (Hz), 5 s (s) train duration, 20 s intertrain interval for 50 min (6000 pulses) 3 times daily for 3 days (total 9 sessions, 54,000 stimuli).
Device: repetitive transcranial magnetic stimulation (rTMS)
A Neurostar TMS Therapy System and Neurostar XPLOR coil system (Neuronetics, Malvern, Pennsylvania) will be used to deliver stimulation.

Sham Comparator: Sham rTMS
Parameters for sham Repetitive Transcranial Magnetic Stimulation (rTMS) are identical to those for active stimulation except that aluminum plate blocks the propagation of a magnetic field. The sound and physical sensation is the same as with the active coil while been biologically inactive.
Device: repetitive transcranial magnetic stimulation (rTMS)
A Neurostar TMS Therapy System and Neurostar XPLOR coil system (Neuronetics, Malvern, Pennsylvania) will be used to deliver stimulation.




Primary Outcome Measures :
  1. Beck Scale for Suicidal Ideation [ Time Frame: Within the 3 days of the TMS trial. ]
    Change in suicidal ideation between baseline assessment and following 3 day TMS trial.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-60 years, of all races and ethnicities;
  • Admitted voluntarily to the adult psychiatric inpatient at PRI;
  • Suffering from a current depressive episode
  • Reason for hospitalization should be a recent suicide attempt or suicidal ideation
  • Current severe suicidal ideation defined by a score >7 on the Beck Scale for Suicidal Ideation
  • Ability to read, write and speak English.

Exclusion Criteria:

  • History of dementia, neurovascular or neurodegenerative conditions
  • Physical disabilities that prohibit task performance (such as blindness or deafness)
  • Choosing to opt out of the research study.
  • Additional exclusion criteria for TMS include the following:

    • a personal history or 1st degree relative with history of epilepsy;
    • a personal history of head injury, aneurysm, stroke, previous cranial neurosurgery, neurological, or migraines;
    • recent use of cocaine or alcohol;
    • ferromagnetic metal implants in the head or neck, active or inactive implants(including device leads), deep brain stimulators, cochlear implants or vagus nerve stimulators;
    • a pacemaker;
    • pregnancy (or the possibility of pregnancy);
    • Medications that lower seizure threshold (bupropion or tricyclic antidepressants, such as thorazine, clozapine, amitriptyline, amoxapine, Norpramin, Sinequan, Tofranil, Pamelor, Vivactil, or Surmontil). Other antidepressant and antipsychotic medications have been deemed exhibit a relatively low seizurogenic potential (Pisani et al. 2002).
    • Patients taking a medication for weight loss and depression called bupropion (Wellbutrin) they will be excluded because it may increase the likelihood of experiencing a seizure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693743


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Pedro L Delgado, MD University of Arkansas

Publications:
Buchwald A. Too soon to say goodbye. 1st ed. New York: Random house; 2006.
Vohs KD, Baumeister R. Escaping the self consumes regulatory resources: a self-regulatory model of suicide. Suicide Science. 2002:33-41.
Hamilton M. Diagnosis and rating of anxiety. The British journal of psychiatry : the journal of mental science. 1969;3:76-9.
Beck AT. Beck Hopelessness Scale. The Psychological Corporation; 1988.
Pascual-Leone A. Handbook of transcranial magnetic stimulation. London New York, NY: Arnold ; Oxford University Press distributor; 2002.

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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02693743     History of Changes
Other Study ID Numbers: 203818
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by University of Arkansas:
suicidality
rTMS
suicide ideation

Additional relevant MeSH terms:
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Suicidal Ideation
Suicide
Self-Injurious Behavior
Behavioral Symptoms