Transcranial Magnetic Stimulation Treatment of Hoarding Disorder
Primary Purpose
Hoarding
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neurostar Transcranial Magnetic Stimulation Therapy System
Sponsored by
About this trial
This is an interventional treatment trial for Hoarding
Eligibility Criteria
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
Sites / Locations
- Hartford Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
rTMS Treatment
Arm Description
NeuroStar Transcranial Magnetic Stimulation Therapy System
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02236767
First Posted
September 4, 2014
Last Updated
August 15, 2016
Sponsor
Hartford Hospital
Collaborators
Neuronetics
1. Study Identification
Unique Protocol Identification Number
NCT02236767
Brief Title
Transcranial Magnetic Stimulation Treatment of Hoarding Disorder
Official Title
Transcranial Magnetic Stimulation Treatment of Hoarding Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hartford Hospital
Collaborators
Neuronetics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hoarding
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rTMS Treatment
Arm Type
Experimental
Arm Description
NeuroStar Transcranial Magnetic Stimulation Therapy System
Intervention Type
Device
Intervention Name(s)
Neurostar Transcranial Magnetic Stimulation Therapy System
Intervention Description
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).
Primary Outcome Measure Information:
Title
The Saving Inventory-Revised (SI-R) Total Score
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gretchen J Diefenbach, Ph.D.
Organizational Affiliation
Hartford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26575452
Citation
Diefenbach GJ, Tolin DF, Hallion LS, Zertuche L, Rabany L, Goethe JW, Assaf M. A case study of clinical and neuroimaging outcomes following repetitive transcranial magnetic stimulation for hoarding disorder. Am J Psychiatry. 2015 Nov 1;172(11):1160-2. doi: 10.1176/appi.ajp.2015.15050602. No abstract available.
Results Reference
derived
Learn more about this trial
Transcranial Magnetic Stimulation Treatment of Hoarding Disorder
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