Accelerated Intermittent Theta Burst Stimulation for Depressive Symptoms (aTBS)

Stanford University

Status: Completed

Conditions: Depression and Suicide

Treatments: Device: Dorsolateral Prefrontal Cortex Accelerated Theta Burst Stimulation; Device: Anterior Cingulate Cortex Accelerated Theta Burst Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03601117

41071

Details and patient eligibility

About

This study evaluates an accelerated schedule of theta-burst stimulation for depressive symptoms in psychiatric inpatients.

A small pilot study (n=22) will be carried out to demonstrate feasibility, using the FDA-approved stimulation site for depression treatment (L-DLPFC). Participants will be offered stimulation at the anterior cingulate cortex (ACC).

Full description

This study intends to investigate whether modifying stimulation parameters enables typical 6-8 week long rTMS protocols to be compressed to only five days. The influence of this accelerated protocol on the length of patient stay in the hospital will be investigated.

Enrollment: 23 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Over 18 years old
• Able to read, understand, and provide written, dated informed consent prior to screening. Participants will be deemed likely to comply with study protocol and communicate with study personnel about adverse events and other clinically important information.
• Currently diagnosed with Major Depressive Disorder (MDD) and/or in a current major depressive episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
• Currently an inpatient at Stanford Hospital
• Meet the threshold on the total HAMD17 score of >/=20 at screening/baseline.
• Qualifies and has access to outpatient rTMS treatment

Exclusion criteria

• Any structural lesion e.g. structural neurological condition, more subcortical lesions than would be expected for age, stroke effecting stimulated area or connected areas or any other clinically significant abnormality that might affect safety, study participation, or confound interpretation of study results.
• Metal implant in brain (e.g. deep brain stimulation), cardiac pacemaker, or cochlear
• History of epilepsy/ seizures (including history of withdrawal/ provoked seizures)
• Shrapnel or any ferromagnetic item in the head
• Pregnancy
• Autism Spectrum disorder
• Active substance use (<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines
• Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation
• Cognitive impairment (including dementia)
• Current severe insomnia (must sleep a minimum of 4 hours the night before stimulation)
• Current mania
• Current unmanageable psychosis
• IQ <70
• Showing symptoms of withdrawal from alcohol or benzodiazepines
• Parkinsonism or other movement d/o determined by PI to interfere with treatment
• More subcortical lesions than would be expected for age or a stroke effecting stimulated area or connected areas.
• Any other indication the PI feels would comprise data.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Dorsolateral Prefrontal Cortex

Experimental group

Description:

The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC), for 10 sessions per day for up to 5 days.

Treatment:

Device: Dorsolateral Prefrontal Cortex Accelerated Theta Burst Stimulation

Anterior Cingulate Cortex

Experimental group

Description:

The accelerated theta burst stimulation protocol will be applied to the left anterior cingulate cortex (ACC), for 10 sessions per day for up to 5 days.

Treatment:

Device: Anterior Cingulate Cortex Accelerated Theta Burst Stimulation