Transcranial Magnetic Stimulation Treatment of Hoarding Disorder

• Sponsor: Hartford Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02236767
• Collaborator: Neuronetics (Other)
• Enrollment: 1
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hoarding	Device: Neurostar Transcranial Magnetic Stimulation Therapy System	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Transcranial Magnetic Stimulation Treatment of Hoarding Disorder
• Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: rTMS Treatment NeuroStar Transcranial Magnetic Stimulation Therapy System	Device: Neurostar 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).

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hartford Hospital	Hartford	Connecticut	United States	06106

Sponsors and Collaborators

• Hartford Hospital
• Neuronetics

Investigators

• Principal Investigator: Gretchen J Diefenbach, Ph.D., Hartford Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hartford Hospital
• ClinicalTrials.gov Identifier: NCT02236767
• Other Study ID Numbers: DIEF003523.4
• First Posted: Sep 11, 2014
• Last Update Posted: Oct 6, 2016
• Last Verified: Aug 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Hoarding Disorder

Study Results

Participant Flow

Arm/Group Title	TMS Therapy
Arm/Group Description	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).
Period Title: Overall Study
STARTED	1
COMPLETED	1
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	TMS Therapy
Arm/Group Description	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).
Overall Participants	1
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58 (0)
Sex: Female, Male (Count of Participants)
Female	1 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	1 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	rTMS Treatment
Arm/Group Description	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).
Measure Participants	1
Pre-baselne	66
Post-baseline/Pre-treatment	60
Post-treatment	46
2-Month Follow-up	45

Adverse Events

Time Frame	6 weeks
Adverse Event Reporting Description	an adverse events checklist was administered
Arm/Group Title	TMS Therapy
Arm/Group Description	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).
All Cause Mortality
	TMS Therapy
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	TMS Therapy
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Other (Not Including Serious) Adverse Events
	TMS Therapy
	Affected / at Risk (%)	# Events
Total	1/1 (100%)
Nervous system disorders
headache	1/1 (100%)	1
eye twitch	1/1 (100%)	1
Skin and subcutaneous tissue disorders
pin prick sensation at treatment site	1/1 (100%)	1
pain discomfort at the treatment site	1/1 (100%)	1
Surgical and medical procedures
tapping sound	1/1 (100%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.