Neuromodulation for Hoarding Disorder and Depression
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of California, San Diego
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The primary goal of this study is to evaluate whether intermittent theta burst stimulation (iTBS) is effective for treating depression in people who have depression and chronic hoarding disorder (HD). The study will also evaluate whether this treatment can improve HD symptoms, cognitive performance, and brain region connectivity. The study team will investigate how the treatment works for depression, as well as other factors that can enhance or hinder treatment, such as pre-treatment level of depression, cognitive performance, or brain region connectivity.
Do I have to stop taking my current medications for the trial?
The trial requires that you stay on your current psychiatric medications if they have been stable for 6 weeks, and no changes are expected during the study period. However, if you are taking lorazepam 2 mg or greater daily (or benzodiazepine equivalent), any anticonvulsant, or medication that lowers seizure threshold, you may not be eligible to participate.
What data supports the idea that Neuromodulation for Hoarding Disorder and Depression is an effective treatment?
The available research shows that intermittent theta burst stimulation (iTBS) has shown promise in treating depression, particularly in cases where other treatments have failed. For example, a study found that iTBS was effective for treatment-resistant depression, with most patients experiencing improvement, although the effects were not long-lasting. Another study highlighted that iTBS over a specific brain area showed promise in open-label trials for depression. While these studies focus on depression, they suggest that iTBS could be a promising treatment option for related conditions like hoarding disorder.
12345What safety data exists for iTBS treatment?
iTBS, or intermittent theta burst stimulation, has been studied for its safety and efficacy in treating various psychiatric disorders, including depression and bipolar depression. Studies have generally reported that iTBS is safe and well-tolerated, with mild adverse effects and no cases of seizures or mania. Specific studies have shown that iTBS is safe for use in major depressive disorder, bipolar depression, and treatment-resistant depression, with no significant adverse events observed. However, some participants have experienced tolerability issues, and further research is needed to confirm long-term safety and efficacy.
678910Is iTBS a promising treatment for hoarding disorder and depression?
iTBS, a noninvasive brain stimulation treatment, shows promise for depression. It is effective, fast-acting, and safe, with potential improvements through multiple daily sessions and precise targeting. This makes it a promising option for treating depression, which could also benefit hoarding disorder.
124611Eligibility Criteria
This trial is for adults aged 18-70 with both depression and hoarding disorder, who have been stable on psychiatric meds for 6 weeks. They must be able to commit to the treatment schedule, complete assessments in English, and not have any MRI or TMS contraindications. Pregnant individuals or those with certain neurological conditions or high suicide risk are excluded.Inclusion Criteria
Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive symptoms
Stated willingness to comply with all study procedures and availability for the duration of the study
My psychiatric medications have been stable for 6 weeks and won't change during the study.
+11 more
Exclusion Criteria
Current substance use disorder per DIAMOND
I am on medication that increases my risk of seizures.
Pregnant or intending to become pregnant within the study period; breastfeeding
+7 more
Participant Groups
The study tests intermittent theta burst stimulation (iTBS) effectiveness on treating depression in patients also suffering from chronic hoarding disorder. It will assess improvements in hoarding symptoms, cognitive function, and brain connectivity related to the treatment.
1Treatment groups
Experimental Treatment
Group I: iTBSExperimental Treatment1 Intervention
intermittent Theta Burst Stimulation (a form of transcranial magnetic stimulation) targeting the left dorsolateral prefrontal cortex
iTBS is already approved in United States for the following indications:
🇺🇸 Approved in United States as iTBS for:
- Treatment-resistant depression
- Major depressive disorder
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UC San DiegoLa Jolla, CA
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Who Is Running the Clinical Trial?
University of California, San DiegoLead Sponsor
References
Dorsomedial prefrontal theta burst stimulation to treat anhedonia, avolition, and blunted affect in schizophrenia or depression - a randomized controlled trial. [2021]Intermittent theta burst stimulation (iTBS) over the dorsomedial prefrontal cortex (DMPFC) has shown promise in open-label trials of depression.
Adjunctive continuous theta burst stimulation for major depressive disorder or bipolar depression: A meta-analysis of randomized controlled studies. [2023]As a novel type of theta burst stimulation (TBS), continuous TBS (cTBS) has been shown to have mixed therapeutic effects for major depressive disorder (MDD) or bipolar depression (BD). Thus, we performed a meta-analysis of randomized controlled trials (RCTs) of cTBS for treating major depressive episodes in patients with MDD or BD.
Cortical Thickness in the Right Anterior Cingulate Cortex Relates to Clinical Response to Left Prefrontal Accelerated Intermittent Theta Burst Stimulation: An Exploratory Study. [2022]Accelerated intermittent theta burst stimulation (aiTBS) is a promising treatment option for depressed patients. However, there is a large interindividual variability in clinical effectiveness and individual biomarkers to guide treatment outcome are needed.
Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. [2020]New antidepressant treatments are needed that are effective, rapid acting, safe, and tolerable. Intermittent theta-burst stimulation (iTBS) is a noninvasive brain stimulation treatment that has been approved by the U.S. Food and Drug Administration for treatment-resistant depression. Recent methodological advances suggest that the current iTBS protocol might be improved through 1) treating patients with multiple sessions per day at optimally spaced intervals, 2) applying a higher overall pulse dose of stimulation, and 3) precision targeting of the left dorsolateral prefrontal cortex (DLPFC) to subgenual anterior cingulate cortex (sgACC) circuit. The authors examined the feasibility, tolerability, and preliminary efficacy of Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), an accelerated, high-dose resting-state functional connectivity MRI (fcMRI)-guided iTBS protocol for treatment-resistant depression.
Is accelerated, high-dose theta burst stimulation a panacea for treatment-resistant depression? [2021]A recent study by Williams et al. (Williams NR, Sudheimer KD, Bentzley BS, Pannu J, Stimpson KH, Duvio D, Cherian K, Hawkins J, Scherrer KH, Vyssoki B, DeSouza D, Raj KS, Keller J, Schatzberg AF. Brain 141: e18, 2018) used accelerated, high-dose intermittent theta burst stimulation (iTBS) to treat highly treatment-resistant depression patients. Remarkably, most patients remitted, but the durability of therapeutic response was weak and all patients relapsed within 2 wk posttreatment. This mini-review examines the "fast on, fast off" effects of accelerated, high-dose iTBS for depression and suggests a new treatment that would combine the strengths of multiple extant iTBS protocols.
Prolonged intermittent theta burst stimulation in the treatment of major depressive disorder: a case series. [2022]Intermittent theta burst stimulation (iTBS) using 600 pulses is an effective and FDA-cleared transcranial magnetic stimulation (TMS) protocol for major depressive disorder (MDD). Prolonged iTBS (piTBS) using 1,800 pulses could increase the effectiveness of TMS for MDD, but its real-world effectiveness is still debated. We assessed the safety, tolerability, and preliminary effectiveness of a 3x daily piTBS 1,800 pulses protocol delivered over 2 weeks in 27 participants. Only four participants (18.2%) achieved response, two of them achieving remission (9.1%). Five participants (18.5%) experienced tolerability issues. Future studies should focus on the neurophysiological effects of TBS protocols to determine optimal parameters.
Twice-daily neuronavigated intermittent theta burst stimulation for bipolar depression: A Randomized Sham-Controlled Pilot Study. [2020]The safety and efficacy of neuronavigated intermittent theta burst stimulation (iTBS) in patients with bipolar depression has not yet been investigated. We hypothesized the superiority of active iTBS over sham. Twenty-six patients were randomly allocated to receive either active (n=12) or sham (n=14) iTBS. Response and remission rates according to changes in depression MADRS score were high following active iTBS (72% and 42% for response and remission rates, respectively), but no significant difference was found after sham stimulation (42%and 25%). No adverse events were observed. This study revealed the safety and tolerability of twice daily iTBS in patients with bipolar depression. Larger controlled studies are warranted to prove iTBS superiority in treatment-resistant bipolar depression.
The antidepressant effect of intermittent theta burst stimulation (iTBS): study protocol for a randomized double-blind sham-controlled trial. [2023]Intermittent theta burst stimulation (iTBS) when applied over the left dorsolateral prefrontal cortex (DLPFC) has been shown to be equally effective and safe to treat depression compared to traditional repetitive transcranial magnetic stimulation (rTMS) paradigms. This protocol describes a funded single-centre, double-blind, randomized placebo-controlled, clinical trial to investigate the antidepressive effects of iTBS and factors associated with an antidepressive response.
Safety and Efficacy of Theta-Burst Stimulation in the Treatment of Psychiatric Disorders: A Review of the Literature. [2019]Theta-burst stimulation (TBS) is a form of repetitive transcranial magnetic stimulation and is thought to induce more rapid and longer-lasting effects on synaptic plasticity than conventional repetitive transcranial magnetic stimulation protocols. TBS is being used as an investigational and more recently as a therapeutic tool. The purpose of this review is to describe and discuss the studies that have evaluated the safety and efficacy of this technique in the treatment of various psychiatric disorders such as depression, schizophrenia, obsessive-compulsive disorder, Tourette's disorder, nicotine and cocaine addiction, and pathological gambling. Studies have reported mild adverse effects but no cases of seizures or mania. Despite the fact that studies were heterogeneous in terms of design and results, some of them are promising mostly for treatment-resistant depression and auditory hallucinations. Future well-designed sham-controlled studies are needed to confirm the long-term safety and efficacy of TBS in the treatment of such conditions.
Accelerated Intermittent Theta Burst Stimulation for Suicide Risk in Therapy-Resistant Depressed Patients: A Randomized, Sham-Controlled Trial. [2020]Objectives: We aimed to examine the effects and safety of accelerated intermittent Theta Burst Stimulation (iTBS) on suicide risk in a group of treatment-resistant unipolar depressed patients, using an extensive suicide assessment scale. Methods: In 50 therapy-resistant, antidepressant-free depressed patients, an intensive protocol of accelerated iTBS was applied over the left dorsolateral prefrontal cortex (DLPFC) in a randomized, sham-controlled crossover design. Patients received 20 iTBS sessions over 4 days. Suicide risk was assessed using the Beck Scale of Suicide ideation (BSI). Results: The iTBS protocol was safe and well tolerated. We observed a significant decrease of the BSI score over time, unrelated to active or sham stimulation and unrelated to depression-response. No worsening of suicidal ideation was observed. The effects of accelerated iTBS on mood and depression severity are reported in Duprat et al. (2016). The decrease in suicide risk lasted up to 1 month after baseline, even in depression non-responders. Conclusions: This accelerated iTBS protocol was safe. The observed significant decrease in suicide risk was unrelated to active or sham stimulation and unrelated to depression response. Further sham-controlled research in suicidal depressed patients is necessary. (Clinicaltrials.gov identifier: NCT01832805).
The longer, the better ? Longer left-sided prolonged intermittent theta burst stimulation in patients with major depressive disorder: A randomized sham-controlled study. [2023]Prolonged intermittent theta-burst stimulation (iTBS) is effective for major depressive disorder (MDD). However, whether longer piTBS treatment in a single session could have antidepressant efficacy remains elusive. Therefore, this double-blind, randomized, sham-controlled study aimed to investigate the antidepressant efficacy of 2 daily piTBS sessions for treating MDD patients with a history of poor responses to at least 1 adequate antidepressant trial in the current episode.