HoardingNCT02236767
Transcranial Magnetic Stimulation Treatment of Hoarding Disorder
A study testing Neurostar Transcranial Magnetic Stimulation Therapy System in people with Hoarding, run by Hartford Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hoarding
- What is being tested?
- Neurostar Transcranial Magnetic Stimulation Therapy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with hoarding disorder as primary disorder
- Clinical Global Impression Score > 3
- Saving Inventory-Revised score > 39
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hoarding
- Being tested
- Neurostar Transcranial Magnetic Stimulation Therapy System
- Medical subject headings
- Hoarding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| rTMS Treatment | Experimental | NeuroStar Transcranial Magnetic Stimulation Therapy System Receives: Device: Neurostar Transcranial Magnetic Stimulation Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-baseline, Post-baseline/Pre-treatment, Post-treatment, 2-Month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HoardingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Neuronetics
- Responsible party
- Sponsor
- Investigators
- Gretchen J Diefenbach, Ph.D., Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236767
- Sponsor's protocol ID
- DIEF003523.4
- Status last verified
- Aug 2016
- First submitted
- 4 Sep 2014
- Last updated
- 6 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26575452
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation Treatment of Hoarding Disorder
- ClinicalTrials.gov ID
- NCT02236767
- Acronym / sponsor ID
- DIEF003523.4
- Conditions
- Hoarding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- Neuronetics
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Posted 6 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rTMS Treatment | Experimental | Device: Neurostar Transcranial Magnetic Stimulation Therapy SystemNeuroStar Transcranial Magnetic Stimulation Therapy System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with hoarding disorder as primary disorder
- Clinical Global Impression Score > 3
- Saving Inventory-Revised score > 39
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurostar Transcranial Magnetic Stimulation Therapy SystemTreatment 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). | Device | rTMS Treatment |
Primary outcome
The Saving Inventory-Revised (SI-R) Total Score
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26575452Diefenbach 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.
- Individual participant dataSharing planned: No
Related trials for Hoarding
Not yet recruiting
A Test of Acceptance-based Bibliotherapy for Hoarding Disorder
Hoarding Disorder
Active, not recruiting
Self-Help Group for the Treatment of Hoarding Disorder
Hoarding Disorder
Active, not recruitingObservational study
Neural Mechanisms of Decision Making in Hoarding Disorder
Hoarding Disorder
Recruiting
Rapid Non-Invasive Brain Stimulation for Hoarding Disorder
Hoarding Disorder, Hoarding
Recruiting
Detection of Hoarding Disorder and Related Psychopathology
Hoarding Disorder, Hoarding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gretchen J Diefenbach, Ph.D. principal investigator
Hartford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurostar Transcranial Magnetic Stimulation Therapy System in people with Hoarding, run by Hartford Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Saving Inventory-Revised (SI-R) Total Score (time frame: Pre-baseline, Post-baseline/Pre-treatment, Post-treatment, 2-Month Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02236767, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2016.