- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06712914
Rapid Non-Invasive Brain Stimulation for Hoarding Disorder (TMS-HOLA)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paula Munoz Rodriguez, PhD
- Phone Number: 650-723-4095
- Email: clutterhelp@stanford.edu
Study Locations
-
-
California
-
Palo Alto, California, United States, 94305
- Recruiting
- Stanford University Medical Center
-
Principal Investigator:
- Carolyn Rodriguez, MD, PhD
-
Contact:
- Paula Munoz Rodriguez, PhD
- Phone Number: 650-723-4095
- Email: clutterhelp@stanford.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-70 years
- Primary diagnosis of hoarding disorder
- Sufficient severity of hoarding symptoms
- Willing and able to understand and complete consent and study procedures
Exclusion Criteria:
- Psychiatric or medical conditions or medications that make participation unsafe
- Pregnant or nursing females
- Previous exposure to TMS or ECT
- History of any implanted device or psychosurgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Theta-burst stimulation (TBS)
Theta-burst stimulation (a form of transcranial magnetic stimulation) targeting the right frontal pole.
|
Participants will receive 5 session per day of TBS for 6 days (30 sessions total).
Six treatment days have to occur within a 2 week period.
Each session will be comprised of 1800 pulses, using a MagVenture MagPro X100.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Compulsive Acquisition Scale (CAS)
Time Frame: Change from baseline to 3 weeks after treatment starts
|
The Compulsive Acquisition Scale (CAS) is an 18-item questionnaire that measures the extent to which individuals acquire and feel compelled to acquire possessions. The total score (sum of 18 items) ranges from 0 to 126. Total score higher than 48 shows significant difficulty with acquiring. |
Change from baseline to 3 weeks after treatment starts
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Hoarding Symptom Severity as Measured by Saving Inventory-Revised (SI-R)
Time Frame: Change from baseline to 3 weeks after treatment starts
|
The Saving Inventory-Revised scale (SI-R) is a 23-item questionnaire with 3 factor-analytically defined sub-scales for difficulty discarding, excessive clutter, and compulsive acquisition. The total score (sum of 23 items) ranges from 0 to 92. Total score higher than 41 shows significant difficulty with clutter. For the acquisition subscale, items 2 (reverse score), 9, 11, 14, 16, 18 and 21 are summed together. The subscale ranges from 0 to 28 and score greater than 13 indicates difficulty with excessive acquisition. For the difficulty discarding subscale, items 4(reverse score), 6, 7, 13, 17, 19, 23 are summed together. The subscale ranges from 0 to 28 and score greater than 13 indicates difficulty with discarding. For the clutter subscale, items 1, 3, 5, 8, 10, 12, 15, 20, 22 are summed together. The subscale ranges from 0 to 36 and score greater than 15 indicates difficulty with accumulated clutter. |
Change from baseline to 3 weeks after treatment starts
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carolyn I Rodriguez, MD, PhD, Stanford University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Communication Disorders
- Language Disorders
- Anxiety Disorders
- Obsessive-Compulsive Disorder
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Hoarding Disorder
- Speech Disorders
- Hoarding
Other Study ID Numbers
- 77098
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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