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acTBS Treatment for Inpatient Subjects With Suicidality

NCT04197765 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-01

No results posted yet for this study

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

Interventions

DEVICE

accelerated Thetaburst stimulation

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.

DEVICE

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2029-01-01
Completion
2029-01-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04197765 on ClinicalTrials.gov