Brain Stimulation for Hoarding Disorder

(TMS-HOLA Trial)

Overseen By Paula Munoz Rodriguez, PhD

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a type of brain stimulation can help people with hoarding disorder. The treatment, called theta-burst stimulation, uses magnetic pulses to target specific brain areas non-invasively. The goal is to determine if it can reduce symptoms of hoarding, such as difficulty letting go of items or clutter in living spaces. Suitable participants have been diagnosed with hoarding disorder and face significant challenges. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for hoarding disorder.

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.

What prior data suggests that this brain stimulation technique is safe for treating hoarding disorder?

Research has shown that theta-burst stimulation (TBS), a type of brain treatment, is generally safe. A review found TBS both safe and effective, but due to its relative novelty, it should be used with care. One study compared TBS to repetitive transcranial magnetic stimulation (rTMS) and found TBS equally safe. Overall, these studies suggest TBS is well-tolerated, but ongoing caution is advised due to its newer status. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for hoarding disorder, which often involve cognitive behavioral therapy or medications like SSRIs, the MagPro X100 offers a new approach through theta-burst stimulation (TBS). TBS is a form of transcranial magnetic stimulation that targets the right frontal pole of the brain. This method is unique because it aims to directly alter brain activity associated with hoarding behaviors, potentially offering faster and more targeted results. Researchers are excited about this treatment because it represents a non-invasive option that could complement or enhance existing therapies, providing new hope for those who struggle with this challenging condition.

What evidence suggests that this brain stimulation is effective for hoarding disorder?

Research has shown that theta-burst stimulation (TBS), a type of brain stimulation, might help reduce symptoms in people with hoarding disorder. In this trial, participants will receive TBS targeting the right frontal pole. Some studies suggest that this kind of brain stimulation effectively treats certain mood and anxiety disorders, such as depression and obsessive-compulsive disorder (OCD), which are similar to hoarding disorder. One case study found that TBS helped a patient with both depression and hoarding disorder. While more research is needed specifically for hoarding, these findings offer hope that TBS could be beneficial. ^{4 6 7 8 9}

Who Is on the Research Team?

Carolyn Rodriguez, MD, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11841443/

A meta-analysis comparing the effectiveness and safety of ... Both rTMS and TBS are similarly effective in reducing depression and anxiety symptoms, with comparable side effect profiles.

2. researchgate.net researchgate.net/publication/377702525_Efficacy_of_theta-burst_repetitive_transcranial_magnetic_stimulation_rTMS_for_treatment_resistant_depression

Efficacy of theta-burst repetitive transcranial magnetic ... We here describe a case of major depressive disorder in comorbidity with a hoarding disorder, treated with repetitive transcranial magnetic ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02236767

Transcranial Magnetic Stimulation Treatment of Hoarding ... A case study of clinical and neuroimaging outcomes following repetitive transcranial magnetic stimulation for hoarding disorder. Am J Psychiatry. 2015 Nov 1 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11524532/

The Efficacy of Transcranial Magnetic Stimulation in the ... Repetitive transcranial magnetic stimulation (rTMS) has been increasingly used for treating obsessive-compulsive disorder (OCD).

5. cpn.or.kr cpn.or.kr/journal/view.html?uid=1745&vmd=Full&

A Case Series on the Effect of Continuous Theta Burst ... Transcranial magnetic stimulation (TMS) is increasingly being used in the management of OCD [1,2] and found to have a moderate effect [2]. Some evidence ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3260517/

Safety of Theta Burst Transcranial Magnetic Stimulation Based on this review, TBS appears to be a safe and efficacious technique. However, given its novelty, it should be applied with caution.

7. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.20240181

Intermittent Theta Burst Stimulation With Adjunctive D- ... In major depression, d-cycloserine can normalize and prolong TMS plasticity (12), and recent randomized placebo-controlled data suggests ...

8. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1504727/full

A meta-analysis comparing the effectiveness and safety of ... Objective: This study compares the safety and effectiveness of theta-burst stimulation (TBS) and repetitive transcranial magnetic stimulation (rTMS) for ...

9. sciencedirect.com sciencedirect.com/science/article/am/pii/S1935861X19303031

Continuous theta burst stimulation over the supplementary ... Despite the improvement in pharmacological and behavioral treatments, 40 to 60 % of patient remain resistant to treatment (3). Therefore, developing ...