Brain Stimulation for Hoarding Disorder

(TMS-HOLA Trial)

Overseen By Tatevik Avanesyan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Pregnancy, Implanted devices, Psychosurgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those with medications that make participation unsafe. It's best to discuss your specific medications with the trial team.

Is brain stimulation generally safe for humans?

Deep brain stimulation (DBS) has been used safely in treating conditions like Parkinson's disease and obsessive-compulsive disorder, with most side effects being mild or moderate and related to the device or procedure. However, there is a risk of serious side effects, including depression and suicidal thoughts, so patients should be carefully monitored. ^{1 2 3 4 5}

How does the MagPro X100 treatment differ from other treatments for hoarding disorder?

The MagPro X100 treatment is unique because it involves brain stimulation, which targets specific brain areas associated with hoarding disorder, unlike traditional therapies that focus on behavioral changes or cognitive strategies. ^{6 7 8 9 10}

What is the purpose of this trial?

This study explores whether rapid non-invasive brain stimulation can help reduce hoarding disorder symptoms.

Research Team

Carolyn Rodriguez, MD, PhD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for adults aged 18-70 with a primary diagnosis of hoarding disorder who can consent to study procedures. Participants should have significant hoarding symptoms but no prior TMS or ECT treatments, implanted medical devices, psychosurgery, unsafe psychiatric/medical conditions or medications, and cannot be pregnant or nursing.

Inclusion Criteria

Willing and able to understand and complete consent and study procedures

I have been diagnosed with hoarding disorder.

Sufficient severity of hoarding symptoms

Exclusion Criteria

I have previously undergone TMS or ECT treatments.

I have had a device implanted or undergone brain surgery.

I do not have any health or mental conditions that make joining unsafe.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive rapid non-invasive brain stimulation targeting the right frontal pole

3 weeks

Follow-up

Participants are monitored for changes in hoarding disorder symptoms after treatment

4 weeks

Treatment Details

Interventions

• MagPro X100

Trial Overview The study tests if the MagPro X100 device by MagVenture can alleviate symptoms of hoarding disorder through rapid non-invasive brain stimulation. It aims to determine the effectiveness and safety of this potential treatment option.

Participant Groups

Group I: Theta-burst stimulation (TBS) Experimental Treatment 1 Intervention

Theta-burst stimulation (a form of transcranial magnetic stimulation) targeting the right frontal pole.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

In a study of 30 patients with severe, treatment-refractory OCD, deep brain stimulation (DBS) showed a 42% reduction in obsessive-compulsive symptoms after 12 months, with a responder rate of 60%.

While all patients experienced adverse events (195 total), most were mild or moderate, and the serious adverse events were primarily transient anxiety and worsening of affective symptoms, suggesting that the benefits of DBS may outweigh the risks in this challenging patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder. Menchón, JM., Real, E., Alonso, P., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Brain stimulation in the treatment of late-life severe mental illness other than unipolar nonpsychotic depression. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Psychiatric and neuropsychiatric adverse events associated with deep brain stimulation: A meta-analysis of ten years' experience. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for obsessive-compulsive disorder: a systematic review and meta-analysis. [2018]

5. Poland pubmed.ncbi.nlm.nih.gov

Deep brain stimulation: new possibilities for the treatment of mental disorders. [2020]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Neuropsychological and neurophysiological insights into hoarding disorder. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Augmenting group hoarding disorder treatment with virtual reality discarding: A pilot study in older adults. [2023]

8. Australia pubmed.ncbi.nlm.nih.gov

Fronto-limbic abnormalities in a patient with compulsive hoarding: a 99mTc-ECD SPECT study. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Changes in neural activity following a randomized trial of cognitive behavioral therapy for hoarding disorder. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Functional Neuroimaging Test of an Emerging Neurobiological Model of Hoarding Disorder. [2020]