Accelerated Intermittent Theta Burst Stimulation for Depressive Symptoms

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2020-06-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Depression and Suicide

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

A small pilot study (n=22) will be an open-label study in which all participants receive stimulation to the L-DLPFC to demonstrate feasibility of delivering this accelerated protocol on an inpatient unit.

For participants who do not respond to L-DLPFC stimulation, we will offer an alternative site, the ACC.

If patients are enrolled that have a psychiatric diagnosis other than MDD, scales measuring symptoms related to their other diagnosis/(es) will also be collected in addition to measuring change in depressive symptoms (see 'other pre-specified outcome measures' for a list of measures used to measure symptoms related to psychiatric diagnoses other than depression).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dorsolateral Prefrontal Cortex

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.

Group Type EXPERIMENTAL

Dorsolateral Prefrontal Cortex Accelerated Theta Burst Stimulation

Intervention Type DEVICE

Participants will receive iTBS (intermittent theta burst stimulation) to the left DLPFC.

Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth).

Stimulation will be delivered using the Brainsway TMS system.

Anterior Cingulate Cortex

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.

Group Type EXPERIMENTAL

Anterior Cingulate Cortex Accelerated Theta Burst Stimulation

Intervention Type DEVICE

Participants will receive iTBS (intermittent theta burst stimulation) to the anterior cingulate cortex (ACC).

Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth).

Stimulation will be delivered using the Brainsway TMS system.

Interventions

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Dorsolateral Prefrontal Cortex Accelerated Theta Burst Stimulation

Participants will receive iTBS (intermittent theta burst stimulation) to the left DLPFC.

Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth).

Stimulation will be delivered using the Brainsway TMS system.

Intervention Type DEVICE

Anterior Cingulate Cortex Accelerated Theta Burst Stimulation

Participants will receive iTBS (intermittent theta burst stimulation) to the anterior cingulate cortex (ACC).

Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth).

Stimulation will be delivered using the Brainsway TMS system.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Nolan R

Assistant Professor, Director, Interventional Psychiatry Clinical Research, Director, Brain Stimulation Laboratory, Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR