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Brain Stimulation

Accelerated TBS for Suicidality

N/A

Waitlist Available

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have not received single-pulse or repetitive-TMS in the past, i.e. considered "TMS naïve".

Inpatients admitted for "suicidality" with a documented diagnosis of MDD

Must not have

History of failed brain stimulation (i.e. rTMS, ECT, VNS, DBS, TNS in the past)

Lifetime diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, current psychotic symptoms

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to final visit

Summary

This trial will test whether a continuous, accelerated form of transcranial magnetic stimulation (TMS) can help inpatients with suicidal ideation. 40 subjects will be recruited and randomly assigned to either the active or sham TMS group. Subjects will complete mood surveys throughout the trial, which will last 7-10 days.

Who is the study for?

This trial is for inpatients aged 18-65 with major depressive disorder (MDD) and current suicidal thoughts, who have never had TMS treatment before. They must pass a safety questionnaire to participate. People with borderline personality disorder, past brain stimulation treatments, schizophrenia spectrum disorders, epilepsy or other major neurological issues can't join.

What is being tested?

The study tests accelerated Thetaburst stimulation (a type of Transcranial magnetic stimulation) on patients with suicidality. Participants are randomly assigned to either real TMS or a sham (fake) treatment over 7-10 days and will complete mood surveys to track changes.

What are the potential side effects?

While the document doesn't list specific side effects, typical ones from TMS may include headache, scalp discomfort at the site of stimulation, tingling or spasms in facial muscles.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never undergone TMS treatment.

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I am hospitalized for suicidal thoughts and have been diagnosed with major depressive disorder.

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I am between 18 and 65 years old.

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I have never undergone TMS therapy before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have tried brain stimulation treatments without success.

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I have been diagnosed with a psychotic disorder like schizophrenia.

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I have a history of epilepsy or a major neurological disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to final visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to final visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to final visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Inventory of Depressive Symptom (Self-report)

Change in Suicidal Ideation Attributes Scales (SI-DAS)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active acTBSActive Control1 Intervention

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.

Group II: ShamPlacebo Group1 Intervention

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.

0 / 7Eligibility criteria met