Neuromodulation for Comorbid Hoarding Disorder and Depression

The primary goal of this study is to evaluate whether intermittent theta burst stimulation (iTBS) is effective for treating depression in people who have depression and chronic hoarding disorder (HD). The study will also evaluate whether this treatment can improve HD symptoms, cognitive performance, and brain region connectivity. The study team will investigate how the treatment works for depression, as well as other factors that can enhance or hinder treatment, such as pre-treatment level of depression, cognitive performance, or brain region connectivity.

Study Overview

• Status: Recruiting
• Conditions: Depression; Hoarding Disorder; Hoarding
• Intervention / Treatment: Device: iTBS

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Zakrzewski, PhD; Phone Number: 858-255-1257; Email: jzakrzewski@health.ucsd.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • UC San Diego
      • Contact: Jessica Zakrzewski, PhD
      • Principal Investigator: Elizabeth Twamley, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male, female, or non-gender conforming individuals (i.e. those who do not identify as male or female)
4. All racial and ethnic groups
5. Ages 18 to 70
6. Meets criteria for current Major Depressive Episode within the context of Major Depressive Disorder, per HAM-D and DIAMOND.
7. Meets criteria for current Hoarding Disorder, per SIHD
8. Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive symptoms
9. Stable on psychiatric medications for 6 weeks, with no changes to psychiatric medications expected during the study period
10. No contraindications to TMS (passes the TMS Adult Safety Screening questionnaire)
11. No contraindications to MRI (passes MRI safety screening questionnaire)
12. Able to commit to the treatment schedule
13. Able to complete assessment procedures in English
14. Intact decision-making capacity and ability to provide voluntary informed consent

Exclusion Criteria:

1. History of other neurological condition including but not limited to: conditions associated with increased intracranial pressure; space occupying brain lesions; cerebral aneurysm; stroke; transient ischemic attack within past two years; Parkinson's disease; Huntington's disease; dementia; multiple sclerosis; history of brain surgery; epilepsy; seizure except those therapeutically induced by electroconvulsive therapy (ECT) or a febrile seizure of infancy
2. Implanted medical devices that are not explicitly recognized as MRI safe, including cardiac pacemaker, medication pump, aneurysm clip, shunt, stimulator, cochlear implant, electrodes, or any other metal object within or near the head (excluding the mouth) that cannot be safely removed
3. Active manic or psychotic illness per DIAMOND
4. Current substance use disorder per DIAMOND
5. Current active suicidal or spontaneously disclosed homicidal ideation. Active suicidal ideation for this study is defined as a score of 3 or greater on the HAMD-17 and/or 3 or more on the PHQ-9.
6. Pregnant or intending to become pregnant within the study period; breastfeeding
7. Other sensory conditions or illnesses precluding participation in assessments or treatment
8. Current dose of lorazepam 2 mg or greater daily (or benzodiazepine equivalent) or any anticonvulsant due to the potential to limit iTBS efficacy
9. Taking medication that lowers seizure threshold
10. Previous failed treatment with rTMS, iTBS, or ECT

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iTBS; intermittent Theta Burst Stimulation (a form of transcranial magnetic stimulation) targeting the left dorsolateral prefrontal cortex	Device: iTBS; iTBS targeting the left dorsolateral prefrontal cortex; 20 sessions over 4 weeks.; Other Names: rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Savings Inventory -- Revised	self-reported symptoms of hoarding disorder	change from baseline to 8 weeks
Hamilton Rating Scale for Depression	depression symptom severity	change from baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hoarding Rating Scale	self-reported symptoms of hoarding disorder	change from baseline to 8 weeks
Patient Health Questionnaire - 9	self-reported symptoms of depression	change from baseline to 8 weeks
Neuropsychological Global Deficit Score	neurocognition composite	change from baseline to 8 weeks
resting state functional connectivity	connectivity between subgenual nucleus accumbens and dorsolateral prefrontal cortex as measured by functional magnetic resonance imaging	change from baseline to 4 weeks

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Elizabeth Twamley, PhD, UC San Diego

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Transcranial magnetic stimulation; TMS
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Anxiety Disorders; Obsessive-Compulsive Disorder; Depression; Depressive Disorder; Hoarding Disorder
• Other Study ID Numbers: RG106837

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data can be de-identified and made available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No