Hoarding
Conditions
Brief summary
This is multiple baseline study including up to three participants with a primary diagnosis of hoarding disorder. All patients will receive unblinded repetitive transcranial magnetic stimulation study intervention.
Detailed description
Study assessments will be conducted at pre-baseline, weekly during baseline assessment (until a stable baseline is established, but not less than 2, 4, and 6 weeks for patients respectively), weekly during treatment, and at post-treatment. Magnetic resonance imaging (MRI) will be competed at pre-baseline, pre-treatment, and post-treatment. Treatment will entail daily (5 days/week) sessions of repetitive transcranial magnetic stimulation using the Neurostar Therapy System for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC). Neuronavigation will direct coil placement over the DLPFC based upon structural MRI.
Interventions
DEVICENeurostar Transcranial Magnetic Stimulation Therapy System
Treatment will entail daily (5 days/week) sessions of repetitive transcranial magnetic stimulation for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC).
Sponsors
Neuronetics
Hartford Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with hoarding disorder as primary disorder * Clinical Global Impression Score \> 3 * Saving Inventory-Revised score \> 39
Exclusion criteria
* Any contraindication for participation in magnetic resonance imaging or transcranial magnetic stimulation * Severe and/or unstable medical or psychiatric condition that require immediate medical attention * Diagnosed with current major depressive episode * Currently taking psychiatric medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Saving Inventory-Revised (SI-R) Total Score | Pre-baseline, Post-baseline/Pre-treatment, Post-treatment, 2-Month Follow-up | The Saving Inventory-Revised (SI-R) is a self-report measure which includes 23 items assessing the severity of hoarding symptoms including difficulty discarding, acquiring, and clutter. The 23 items are added for a total score which ranges from 0 to 92 and with higher score indicating more severe hoarding symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TMS Therapy NeuroStar TMS Therapy System
Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC). | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | TMS Therapy |
|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 0 |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
The Saving Inventory-Revised (SI-R) Total Score
The Saving Inventory-Revised (SI-R) is a self-report measure which includes 23 items assessing the severity of hoarding symptoms including difficulty discarding, acquiring, and clutter. The 23 items are added for a total score which ranges from 0 to 92 and with higher score indicating more severe hoarding symptoms.
Time frame: Pre-baseline, Post-baseline/Pre-treatment, Post-treatment, 2-Month Follow-up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rTMS Treatment | The Saving Inventory-Revised (SI-R) Total Score | Pre-baselne | 66 units on a scale |
| rTMS Treatment | The Saving Inventory-Revised (SI-R) Total Score | Post-baseline/Pre-treatment | 60 units on a scale |
| rTMS Treatment | The Saving Inventory-Revised (SI-R) Total Score | Post-treatment | 46 units on a scale |
| rTMS Treatment | The Saving Inventory-Revised (SI-R) Total Score | 2-Month Follow-up | 45 units on a scale |