Theta Burst Stimulation for Depression and Autism (RETSORE-RCT Trial)
Palo Alto (17 mi)Age: < 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Children's Hospital Medical Center, Cincinnati
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?Evaluate the efficacy of accelerated theta burst stimulation (aTBS) in reducing depressive symptoms in autism spectrum disorder (ASD)
Is Theta Burst Stimulation a promising treatment for depression and autism?Yes, Theta Burst Stimulation (TBS) is a promising treatment for depression. Studies show it can help improve symptoms when used alongside other treatments like medication and therapy. It is a type of brain stimulation that uses magnetic pulses to influence brain activity.34789
What data supports the idea that Theta Burst Stimulation for Depression and Autism is an effective treatment?The available research shows that Theta Burst Stimulation (TBS) can be effective for treating major depressive disorder (MDD). One study found that a specific TBS protocol, called intermittent theta burst stimulation (iTBS), is FDA-cleared and effective for MDD. However, when the protocol was extended to a higher dose, only 18.2% of participants showed improvement, and 9.1% achieved remission. Another study tested bilateral TBS combined with medication and therapy, suggesting it could be beneficial for depression. A meta-analysis of continuous TBS (cTBS) showed mixed results for depression, indicating that while TBS can be helpful, its effectiveness may vary. There is no specific data provided for TBS's effectiveness in treating autism.34789
What safety data exists for Theta Burst Stimulation (TBS) treatment?Several studies have evaluated the safety of Theta Burst Stimulation (TBS) for depression and autism. A study comparing TBS with other TMS methods in 165 pediatric subjects found the safety profile of TBS to be unknown. Another study with 33 patients with major depression found TBS to be safe and well-tolerated, with no increase in side effects at higher stimulation parameters. A case series involving prolonged iTBS in 27 participants reported some tolerability issues but generally supported its safety. A systematic review of literature from 2004 to 2009 found that most adverse events from TBS were mild, occurring in 5% of subjects, and highlighted the need for caution and further research on seizure risk. Overall, TBS appears to be safe but should be applied cautiously due to its novelty.12568
Do I have to stop taking my current medications?You don't have to stop taking your current medications, but you should try to keep them stable during the study. However, if you are currently using anticonvulsants, barbiturates, lithium, or benzodiazepines, you cannot participate in the trial.
Eligibility Criteria
This trial is for individuals with Autism Spectrum Disorder (ASD) who are also experiencing hard-to-treat depression. Participants should be diagnosed with both conditions and have not found relief from standard treatments.Inclusion Criteria
I am between 13 and 26 years old.
I have moderate to severe depression.
Exclusion Criteria
I have previously undergone rTMS treatment.
I do not have epilepsy, metallic implants, or a pacemaker.
I am currently taking medication for seizures, mood, or anxiety.
Treatment Details
The study is testing the effectiveness of a technique called accelerated theta burst stimulation (aTBS), which uses magnetic fields to stimulate certain areas of the brain, in reducing symptoms of depression in people with ASD.
2Treatment groups
Active Control
Placebo Group
Group I: Active TBS TreatmentActive Control1 Intervention
Active aTBS targeting the left dorsolateral prefrontal cortex, 5 sessions per day for 5 days.
Group II: Sham controlledPlacebo Group1 Intervention
Sham aTBS targeting the left dorsolateral prefrontal cortex, 5 sessions per day for 5 days. If participants in the sham group do not show a significant treatment response by the 12-week follow-up - defined as a 50% reduction from baseline on the HDRS- they will then become eligible for and offered active, open-label treatment.
Theta Burst Stimulation is already approved in United States for the following indications:
🇺🇸 Approved in United States as Theta Burst Stimulation for:
- Major Depressive Disorder
Find a clinic near you
Research locations nearbySelect from list below to view details:
Cincinnati Childrens Hospital Medical CenterCincinnati, OH
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Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
References
Safety, tolerability and preliminary evidence for antidepressant efficacy of theta-burst transcranial magnetic stimulation in patients with major depression. [2019]The aim of this open study was to evaluate the safety and tolerability of theta-burst transcranial magnetic stimulation (TBS) and to assess preliminarily its therapeutic efficacy in patients with major depression. A total of 33 patients were assigned to receive one of four TBS protocols for 10 consecutive work days. TBS consisted of triple-pulse 50-Hz bursts given at a rate of 5 Hz to the left or right dorsolateral prefrontal cortex at different stimulation parameters. Severity of depression was assessed by the Hamilton Depression Rating Scale. Our results indicate that TBS as applied in this study is safe and well tolerated in depressed patients and seems to have antidepressant properties. Increase of stimulation parameters is not associated with more side-effects and adds to its therapeutic effect.
Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. [2022]Theta burst stimulation (TBS) protocols have recently emerged as a method to transiently alter cortical excitability in the human brain through repetitive transcranial magnetic stimulation. TBS involves applying short trains of stimuli at high frequency repeated at intervals of 200 milliseconds. Because repetitive transcranial magnetic stimulation is known to carry a risk of seizures, safety guidelines have been established. TBS has the theoretical potential of conferring an even higher risk of seizure than other repetitive transcranial magnetic stimulation protocols because it delivers high-frequency bursts. In light of the recent report of a seizure induced by TBS, the safety of this new protocol deserves consideration. We performed an English language literature search and reviewed all studies published from May 2004 to December 2009 in which TBS was applied. The adverse events were documented, and crude risk was calculated. The majority of adverse events attributed to TBS were mild and occurred in 5% of subjects. Based on this review, TBS seems to be a safe and efficacious technique. However, given its novelty, it should be applied with caution. Additionally, this review highlights the need for rigorous documentation of adverse events associated with TBS and intensity dosing studies to assess the seizure risk associated with various stimulation parameters (e.g., frequency, intensity, and location).
Dose-dependence of changes in cortical protein expression induced with repeated transcranial magnetic theta-burst stimulation in the rat. [2016]Theta Burst stimulation (TBS) applied via transcranial magnetic stimulation (TMS) effectively modulates human neocortical excitability but repeated applications of the same TBS protocol at short intervals may be not simply accumulative.
Treatment of major depression with bilateral theta burst stimulation: a randomized controlled pilot trial. [2018]Current efforts to improve clinical effectiveness and utility of repetitive transcranial magnetic stimulation (rTMS) in the treatment of major depression (MD) include theta burst stimulation (TBS), a patterned form of rTMS. Here, we investigated the efficacy of bilateral TBS to the dorsolateral prefrontal cortex (dlPFC) in patients with MD in additon to ongoing medication and psychotherapy.
The acute effects of accelerated repetitive Transcranial Magnetic Stimulation on suicide risk in unipolar depression: preliminary results. [2022]Suicide is a major health concern. Effective acute interventions are lacking. Recent studies have suggested an acute decrease of suicidal ideations following repetitive Transcranial Magnetic Stimulation (rTMS). However, placebo effects could not be excluded. We aimed to evaluate the acute effect of accelerated intermittent theta burst stimulation (TBS) on suicide risk in depression.
Safety and tolerability of theta burst stimulation vs. single and paired pulse transcranial magnetic stimulation: a comparative study of 165 pediatric subjects. [2020]Although single- and paired-pulse (sp/pp) transcranial magnetic stimulation (TMS) studies are considered minimal risk in adults and children, the safety profile for theta-burst TMS (TBS) is unknown.
Probing changes in corticospinal excitability following theta burst stimulation of the human primary motor cortex. [2017]To determine whether the intensity of transcranial magnetic stimulation (TMS) used to probe changes in corticospinal excitability influences the measured plasticity response to theta burst stimulation (TBS) of the human primary motor cortex.
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.
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.