Trial Outcomes & Findings for Transcranial Magnetic Stimulation Treatment of Hoarding Disorder (NCT NCT02236767)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

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

Results posted on

2016-10-06

Participant Flow

Participant milestones

Participant milestones
Measure	TMS Therapy 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 Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transcranial Magnetic Stimulation Treatment of Hoarding Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TMS Therapy n=1 Participants 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).
Age, Continuous	58 years STANDARD_DEVIATION 0 • n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment United States	1 participants n=99 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	rTMS Treatment n=1 Participants 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).
The Saving Inventory-Revised (SI-R) Total Score Pre-baselne	66 units on a scale
The Saving Inventory-Revised (SI-R) Total Score Post-baseline/Pre-treatment	60 units on a scale
The Saving Inventory-Revised (SI-R) Total Score Post-treatment	46 units on a scale
The Saving Inventory-Revised (SI-R) Total Score 2-Month Follow-up	45 units on a scale

Adverse Events

TMS Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	TMS Therapy n=1 participants at risk 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).
Surgical and medical procedures tapping sound	100.0% 1/1 • Number of events 1 • 6 weeks an adverse events checklist was administered
Skin and subcutaneous tissue disorders pin prick sensation at treatment site	100.0% 1/1 • Number of events 1 • 6 weeks an adverse events checklist was administered
Skin and subcutaneous tissue disorders pain discomfort at the treatment site	100.0% 1/1 • Number of events 1 • 6 weeks an adverse events checklist was administered
Nervous system disorders headache	100.0% 1/1 • Number of events 1 • 6 weeks an adverse events checklist was administered
Nervous system disorders eye twitch	100.0% 1/1 • Number of events 1 • 6 weeks an adverse events checklist was administered

Additional Information

Gretchen Diefenbach

Hartford Hospital

Phone: 860-545-7396

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place