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

NCT02693743 | Terminated Results FDA Device

• 1 other identifier: 203818
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation

Keywords

suicidality; rTMS; suicide ideation

Outcome Measures

Primary Outcomes (1)

• Beck Scale for Suicidal Ideation

  Change in suicidal ideation between baseline assessment and following 3 day TMS trial.

  Within the 3 days of the TMS trial.

Study Arms (2)

Active rTMS

ACTIVE COMPARATOR

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)

Sham rTMS

SHAM COMPARATOR

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)

Interventions

repetitive transcranial magnetic stimulation (rTMS) DEVICE

A Neurostar TMS Therapy System and Neurostar XPLOR coil system (Neuronetics, Malvern, Pennsylvania) will be used to deliver stimulation.

Active rTMS; Sham rTMS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

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MeSH Terms

Conditions

Suicidal Ideation

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Favrin Smith
• Organization: University of Arkansas for Medical Sciences

SmithFavrinM@uams.edu

1 (501) 526-8488

Study Officials

• Pedro L Delgado, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: February 29, 2016
• Study Start: May 22, 2017
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: May 18, 2021
• Results First Posted: April 22, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)