Transcranial Magnetic Stimulation Treatment of Hoarding Disorder

Hoarding Clinical Trial

Official title:

Transcranial Magnetic Stimulation Treatment of Hoarding Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236767
• Other study ID #: DIEF003523.4
• Status: Completed
• Phase: N/A
• First received: September 4, 2014
• Last updated: April 8, 2015
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: September 2014
• Source: Hartford Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is multiple baseline study including up to three participants with a primary diagnosis of hoarding disorder. All patients will receive unblinded rTMS study intervention.

Description:

Study assessments will be conducted at pretreatment, 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 posttreatment. Magnetic resonance imaging (MRI) will be competed at prebaseline, pretreatment, and posttreatment. Treatment will entail daily (5 days/week) sessions of rTMS 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with HD as primary disorder

• Clinical Global Impression Score > 3

• Saving Inventory-Revised score > 39

Exclusion Criteria:

• Any contraindication for participation in MRI or TMS

• Severe and/or unstable medical or psychiatric condition that require immediate medical attention

• Diagnosed with current major depressive episode

• Currently taking psychiatric medication

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hoarding

Intervention

Device:
• TMS Neurostar 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).

Locations

Country	Name	City	State
United States	Hartford Hospital	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Hartford Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in discarding subscale of The Saving Inventory-Revised (SI-R)		Participants will be assessed weekly for the duration of the study (average duration will be 10 weeks)	No