Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 35 of 1360 for:    transcranial magnetic stimulation

Transcranial Magnetic Stimulation Treatment of Hoarding Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02236767
Recruitment Status : Completed
First Posted : September 11, 2014
Results First Posted : October 6, 2016
Last Update Posted : October 6, 2016
Sponsor:
Collaborator:
Neuronetics
Information provided by (Responsible Party):
Hartford Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hoarding
Intervention Device: Neurostar Transcranial Magnetic Stimulation Therapy System
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TMS Therapy
Hide 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
Arm/Group Title TMS Therapy
Hide 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 Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants
58  (0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title The Saving Inventory-Revised (SI-R) Total Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rTMS Treatment
Hide 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 Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: units on a scale
Pre-baselne 66
Post-baseline/Pre-treatment 60
Post-treatment 46
2-Month Follow-up 45
Time Frame 6 weeks
Adverse Event Reporting Description an adverse events checklist was administered
 
Arm/Group Title TMS Therapy
Hide 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 (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
TMS Therapy
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TMS Therapy
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Nervous system disorders   
headache   1/1 (100.00%)  1
eye twitch   1/1 (100.00%)  1
Skin and subcutaneous tissue disorders   
pin prick sensation at treatment site   1/1 (100.00%)  1
pain discomfort at the treatment site   1/1 (100.00%)  1
Surgical and medical procedures   
tapping sound   1/1 (100.00%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Gretchen Diefenbach
Organization: Hartford Hospital
Phone: 860-545-7396
Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT02236767     History of Changes
Other Study ID Numbers: DIEF003523.4
First Submitted: September 4, 2014
First Posted: September 11, 2014
Results First Submitted: March 25, 2016
Results First Posted: October 6, 2016
Last Update Posted: October 6, 2016