acTBS Treatment for Inpatient Subjects With Suicidality

NCT04197765 | Active Not Recruiting FDA Device

• 1 other identifier: 19-001320
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to analyze the benefit of accelerated continuous Transcranial magnetic stimulation for inpatient subjects suffering with suicidal ideation. This study will enroll 40 inpatient subjects recruited from the Resnick Neuropsychiatric hospital. Subjects will be blinded and randomized to active or sham TMS treatment and will receive up to 5 assigned treatments per day. Subjects will also be asked to complete mood surveys throughout their participation. Participation in this study will last 7-10 days depending on scheduling.

Conditions

Suicidality

Outcome Measures

Primary Outcomes (2)

• Change in Suicidal Ideation Attributes Scales (SI-DAS)

  This 5-item questionnaire is a self-report measure that asks completers to rate the frequency, controllability, closeness to attempt, distress, and interference of suicidal thinking with daily activities from 0-10, with 10 indicating extreme intensity. The SIDAS takes approximately 30-60 seconds to complete and has excellent internal reliability, sensitivity, and specificity. The score is calculated as the sum of the five items. Scores of 21 or above denote high suicidal ideation. A lower score indicates improvement in suicidality.

  Baseline to Final visit

• Change in Inventory of Depressive Symptom (Self-report)

  The 30-item questionnaire used to assess the severity of depressive symptoms. The scale covers symptoms such as as mood reactivity, distinct mood quality, diurnal mood variation, irritable mood, anxious mood, capacity for pleasure, sexual interest, bodily aches and pains, panic or phobic symptoms, digestive problems, interpersonal rejection sensitivity, and leaden paralysis. The sum of the 30 items yields the overall score. A higher score indicates worsening in depressive symptoms. Score ranges from 0 to 84.

  Baseline to final visit

Study Arms (2)

Sham

SHAM COMPARATOR

All parameters will be programmed in the same way as active treatment, however, the treatment will be delivered on the side of the coil that has an internal (hidden) metal shield that will prevent magnetic energy from reaching the skull and brain. Neither the technician, treating physician, nor the patient, will know whether the treatment was delivered from the sham or active side of the coil. The same auditory and tactile cues will be present during active and sham treatment as electrodes will be placed on the scalps of each participant (whether receiving active or sham treatment) that deliver some electrical sensation.

Device: Sham Comparator

Active acTBS

ACTIVE COMPARATOR

For the first three treatments, the study psychiatrist will set treatment intensity to 90% MT, and gradually increase intensity to 120% MT over 20 seconds to maximize tolerability. Subsequent treatment sessions (treatment 4 and onward) will begin, and remain, at 120% MT. Treatment will occur 4-5 times a day, separated by an at least 45-min interval between sessions on consecutive weekdays.

Device: accelerated Thetaburst stimulation

Interventions

accelerated Thetaburst stimulation DEVICE

We will administer 20-30 treatment sessions over the course of the study. The study technician will place the coil over the Fp2 electrode of a 10-20 International EEG system hair net, to approximate stimulation of the R-OFC). For the first three treatments, the study psychiatrist will set treatment intensity to 90% MT, and gradually increase intensity to 120% MT over 20 seconds to maximize tolerability. Subsequent treatment sessions (treatment 4 and onward) will begin, and remain, at 120% MT. Treatment will occur 4-5 times a day, separated by an at least 45-min interval between sessions on consecutive weekdays. We estimate all study-related treatments will be complete in 5-6 weekdays.

Active acTBS

Sham Comparator DEVICE

All parameters will be programmed in the same way as active treatment, however, the treatment will be delivered on the side of the coil that has an internal (hidden) metal shield that will prevent magnetic energy from reaching the skull and brain. Neither the technician, treating physician, nor the patient, will know whether the treatment was delivered from the sham or active side of the coil. The same auditory and tactile cues will be present during active and sham treatment as electrodes will be placed on the scalps of each participant (whether receiving active or sham treatment) that deliver some electrical sensation.

Sham

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inpatients admitted for "suicidality" with a documented diagnosis of MDD
• Between the ages of 18 and 65
• No safety concerns endorsed on the Screening 13-item Questionnaire for rTMS Candidates16
• Have not received single-pulse or repetitive-TMS in the past, i.e. considered "TMS naïve".

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Resnick Neuropsychiatric Hospital

Los Angeles, California, 90025, United States

Location

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 13, 2019
• Study Start: January 1, 2020
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)