Accelerated Intermittent Theta Burst Stimulation for Depressive Symptoms

NCT03601117 | Completed Results FDA Device

• 1 other identifier: 41071
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Depression and Suicide

Outcome Measures

Primary Outcomes (1)

• Change in Montgomery Asberg Depression Rating Scale (MADRS) Score

  A 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Severity gradations for the MADRS have been proposed: 9-17 = mild depression, 18-34 = moderate depression, and ≥ 35 = severe depression. Scores range from 0-60 (higher scores are more symptomatic). Response is defined as a 50% reduction or greater in MADRS score compared to baseline. Remission is defined as a MADRS score of \<10. Data are presented as a raw score point change.

  After all stimulation sessions have been completed (approximately 48 hours after the final session)

Secondary Outcomes (14)

• Change in Scale of Suicidal Ideation (SSI) Score

  After all stimulation sessions have been completed (approximately 48 hours after the final session)

• Change in Hamilton Rating Scale for Depression Six Item (HAMD-6) Score

  After all stimulation sessions have been completed (approximately 48 hours after the final session)

• Change in Young Mania Rating Scale (YMRS)

  After all stimulation sessions have been completed (approximately 48 hours after the final session)

• Change in Beck Depression Inventory II (BDI-II)

  After all stimulation sessions have been completed (approximately 48 hours after the final session)

• Change in Quick Inventory Depressive Scale-Self Reported (QIDS) Score

  After all stimulation sessions have been completed (approximately 48 hours after the final session)

Other Outcomes (15)

• Change in Alcohol Craving Questionnaire Score (Adapted for All Drug Use)

  After all stimulation sessions have been completed (approximately 48 hours after the final session)

• Change in Borderline Evaluation Of Severity Over Time (BEST) Score

  After all stimulation sessions have been completed (approximately 48 hours after the final session)

• Change in Obsessive Compulsive Drinking Scale Score (Adapted for Use of Any Drug)

  After all stimulation sessions have been completed (approximately 48 hours after the final session)

Study Arms (2)

Dorsolateral Prefrontal Cortex

EXPERIMENTAL

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.

Device: Dorsolateral Prefrontal Cortex Accelerated Theta Burst Stimulation

Anterior Cingulate Cortex

EXPERIMENTAL

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.

Device: Anterior Cingulate Cortex Accelerated Theta Burst Stimulation

Interventions

Dorsolateral Prefrontal Cortex Accelerated Theta Burst Stimulation 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.

Dorsolateral Prefrontal Cortex

Anterior Cingulate Cortex Accelerated Theta Burst Stimulation 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.

Anterior Cingulate Cortex

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital

Palo Alto, California, 94305, United States

Location

Related Publications (3)

• George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.

  PMID: 20439832 BACKGROUND

• George MS, Wassermann EM, Williams WA, Callahan A, Ketter TA, Basser P, Hallett M, Post RM. Daily repetitive transcranial magnetic stimulation (rTMS) improves mood in depression. Neuroreport. 1995 Oct 2;6(14):1853-6. doi: 10.1097/00001756-199510020-00008.

  PMID: 8547583 BACKGROUND

• Pascual-Leone A, Rubio B, Pallardo F, Catala MD. Rapid-rate transcranial magnetic stimulation of left dorsolateral prefrontal cortex in drug-resistant depression. Lancet. 1996 Jul 27;348(9022):233-7. doi: 10.1016/s0140-6736(96)01219-6.

  PMID: 8684201 BACKGROUND

MeSH Terms

Conditions

Depression; Suicide

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Self-Injurious Behavior

Results Point of Contact

• Title: Dr Nolan Williams
• Organization: Stanford University

nolanw@stanford.edu

(650)800-6920

Study Officials

• Nolan Williams, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Director, Interventional Psychiatry Clinical Research, Director, Brain Stimulation Laboratory, Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine

Model Details: 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).

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: July 26, 2018
• Study Start: July 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: May 18, 2022
• Results First Posted: August 10, 2021

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)