Neuromodulation for Comorbid Hoarding Disorder and Depression

Study Overview
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Brief Summary
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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.

Official Title
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Neuromodulation for Comorbid Hoarding Disorder and Depression

Conditions
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Hoarding Disorder, Hoarding, Depression

Intervention / Treatment
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* Device: iTBS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male, female, or non-gender conforming individuals (i.e. those who do not identify as male or female) All racial and ethnic groups Ages 18 to 70 Meets criteria for current Major Depressive Episode within the context of Major Depressive Disorder, per HAM-D and DIAMOND. Meets criteria for current Hoarding Disorder, per SIHD Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive symptoms Stable on psychiatric medications for 6 weeks, with no changes to psychiatric medications expected during the study period No contraindications to TMS (passes the TMS Adult Safety Screening questionnaire) No contraindications to MRI (passes MRI safety screening questionnaire) Able to commit to the treatment schedule Able to complete assessment procedures in English Intact decision-making capacity and ability to provide voluntary informed consent Exclusion Criteria: 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 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 Active manic or psychotic illness per DIAMOND Current substance use disorder per DIAMOND 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. Pregnant or intending to become pregnant within the study period; breastfeeding Other sensory conditions or illnesses precluding participation in assessments or treatment Current dose of lorazepam 2 mg or greater daily (or benzodiazepine equivalent) or any anticonvulsant due to the potential to limit iTBS efficacy Taking medication that lowers seizure threshold Previous failed treatment with rTMS, iTBS, or ECT

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TMS, Transcranial magnetic stimulation