NCT02236767

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

October 6, 2016

Completed
Last Updated

October 6, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

September 4, 2014

Results QC Date

March 25, 2016

Last Update Submit

August 15, 2016

Conditions

Hoarding

Outcome Measures

Primary Outcomes (1)

  • 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.

    Pre-baseline, Post-baseline/Pre-treatment, Post-treatment, 2-Month Follow-up

Study Arms (1)

rTMS Treatment

EXPERIMENTAL

NeuroStar Transcranial Magnetic Stimulation Therapy System

Device: Neurostar Transcranial Magnetic Stimulation Therapy System

Interventions

Neurostar Transcranial Magnetic Stimulation Therapy SystemDEVICE

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).

rTMS Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with hoarding disorder as primary disorder
  • Clinical Global Impression Score \> 3
  • Saving Inventory-Revised score \> 39

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Related Publications (1)

  • 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.

    PMID: 26575452DERIVED

MeSH Terms

Conditions

Hoarding

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Gretchen Diefenbach
Organization
Hartford Hospital
gretchen.diefenbach@hhchealth.org
860-545-7396

Study Officials

  • Gretchen J Diefenbach, Ph.D.

    Hartford Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2014

First Posted

September 11, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

October 6, 2016

Results First Posted

October 6, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)