Theta Burst Stimulation for Adolescent Depression
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The Royal Ottawa Mental Health Centre
Must be taking: Antidepressants
Must not be taking: Illegal drugs, High-dose lorazepam
Disqualifiers: Bipolar disorder, Substance abuse, Unstable medical, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Theta burst stimulation (TBS), a type of rTMS, is a very promising new treatment for major depression in adults and adolescents. However, very few studies have assessed the efficacy of accelerated, three times a day TBS in comparison with standard once a day TBS in adolescents. The study aims to explore further evidence in hopes to conduct a large-scale, randomized, multisite, placebo-controlled clinical trial evaluating the effects of a functional magnetic resonance imaging (fMRI)-guided accelerated rTMS protocol vs. standard once/daily rTMS for treatment-resistant depression in adolescents.
Will I have to stop taking my current medications?
The trial requires that you have stable psychotropic medications (medications affecting mood, perception, or behavior) for at least four weeks before participating. You must also be willing to maintain your current antidepressant regimen during the study.
What data supports the effectiveness of the treatment Theta Burst Stimulation (TBS) for adolescent depression?
Research shows that Theta Burst Stimulation (TBS), a type of brain stimulation therapy, is promising for treating major depressive disorder (MDD) in youth who don't respond to other treatments. Studies have found that certain brain activity patterns can predict who will benefit most from TBS, suggesting it could be an effective option for some adolescents with depression.
12345Is theta burst stimulation (TBS) safe for humans?
Research shows that theta burst stimulation (TBS) is generally safe and well tolerated in humans, with mild side effects like headaches being the most common. Studies on TBS for depression indicate it is safe, even with increased stimulation parameters, and does not lead to more side effects.
12678How is Theta Burst Stimulation (TBS) different from other treatments for adolescent depression?
Theta Burst Stimulation (TBS) is a unique form of transcranial magnetic stimulation (TMS) that uses rapid bursts of magnetic pulses to target specific brain areas, potentially offering a faster and more efficient treatment for depression compared to traditional TMS. It is particularly promising for adolescents who do not respond to conventional therapies, and it can be administered in accelerated sessions for quicker results.
12345Eligibility Criteria
This trial is for adolescents with major depression who haven't improved with standard treatments. Participants must be able to undergo fMRI scans and TBS sessions. Specific details on inclusion and exclusion criteria are not provided, but typically these would outline health conditions or medications that might interfere with the treatment.Inclusion Criteria
I am willing and able to give my consent to participate.
Can speak and read English
My mental health treatment has been stable for at least 4 weeks.
+5 more
Exclusion Criteria
Are pregnant or breastfeeding, or plan to become pregnant during treatment (pregnancy will be assessed by a urine test)
I cannot have TMS or MRI due to conditions like epilepsy or having a metal implant.
I do not have any uncontrolled major illnesses like diabetes or kidney problems.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
1 visit (in-person)
Baseline Assessment
Participants complete clinical assessments and self-report questionnaires for baseline measurement
1 week
1 visit (in-person)
Treatment
Participants receive iTBS applied to the left DLPFC. Accelerated group: 3 times a day for 2 weeks. Standard group: once a day for 6 weeks.
2-6 weeks
Daily sessions (Mon-Fri)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with clinical assessments and self-report questionnaires
12 weeks
3 visits (in-person) at 2, 4, and 12 weeks post-treatment
Participant Groups
The study tests if using Theta Burst Stimulation (TBS), a type of brain stimulation therapy, three times a day works better than once daily for treating depression in adolescents. It's guided by fMRI scans to target specific brain areas.
2Treatment groups
Active Control
Group I: Accelerated iTBSActive Control1 Intervention
Intermittent Theta Burst Stimulation (iTBS) will be applied to the left dorsolateral prefrontal cortex (DLPFC). Participants will receive daily sessions (Mon-Fri), three times a day for 10 days (2 weeks).
Group II: Standard iTBSActive Control1 Intervention
Intermittent Theta Burst Stimulation (iTBS) will be applied to the left DLPFC. Participants will receive daily sessions (Mon-Fri), once a day for 30 days (6 weeks).
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:
The Royal's Institute of Mental Health ResearchOttawa, Canada
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Who Is Running the Clinical Trial?
The Royal Ottawa Mental Health CentreLead Sponsor
Université de SherbrookeCollaborator
References
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.
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.
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.
Baseline markers of cortical excitation and inhibition predict response to theta burst stimulation treatment for youth depression. [2023]Theta burst stimulation (TBS), a specific form of repetitive transcranial magnetic stimulation (TMS), is a promising treatment for youth with Major Depressive Disorder (MDD) who do not respond to conventional therapies. However, given the variable response to TBS, a greater understanding of how baseline features relate to clinical response is needed to identify which patients are most likely to benefit from this treatment. In the current study, we sought to determine if baseline neurophysiology, specifically cortical excitation and/or inhibition, is associated with antidepressant response to TBS. In two independent open-label clinical trials, youth (aged 16-24 years old) with MDD underwent bilateral dorsolateral prefrontal cortex (DLPFC) TBS treatment. Clinical trial one and two consisted of 10 and 20 daily sessions of bilateral DLPFC TBS, respectively. At baseline, single-pulse TMS combined with electroencephalography was used to assess the neurophysiology of 4 cortical sites: bilateral DLPFC and inferior parietal lobule. Measures of cortical excitation and inhibition were indexed by TMS-evoked potentials (i.e., P30, N45, P60, N100, and P200). Depression severity was measured before, during and after treatment completion using the Hamilton Rating Scale for Depression-17. In both clinical trials, the baseline left DLPFC N45 and P60, which are believed to reflect inhibitory and excitatory mechanisms respectively, were predictors of clinical response. Specifically, greater (i.e., more negative) N45 and smaller P60 baseline values were associated with greater treatment response to TBS. Accordingly, cortical excitation and inhibition circuitry of the left DLPFC may have value as a TBS treatment response biomarker for youth with MDD.Clinical trial 1 registration number: NCT02472470 (June 15, 2015).Clinical trial 2 registration number: NCT03708172 (October 17, 2018).
Sequential bilateral accelerated theta burst stimulation in adolescents with suicidal ideation associated with major depressive disorder: Protocol for a randomized controlled trial. [2023]Suicide is a leading cause of death in adolescents worldwide. Previous research findings suggest that suicidal adolescents with depression have pathophysiological dorsolateral prefrontal cortex (DLPFC) deficits in γ-aminobutyric acid neurotransmission. Interventions with transcranial magnetic stimulation (TMS) directly address these underlying pathophysiological deficits in the prefrontal cortex. Theta burst stimulation (TBS) is newer dosing approach for TMS. Accelerated TBS (aTBS) involves administering multiple sessions of TMS daily as this dosing may be more efficient, tolerable, and rapid acting than standard TMS.
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.
Accelerated theta-burst repetitive transcranial magnetic stimulation for depression in South Africa. [2020]This case series documents local experience using accelerated theta-burst repetitive transcranial magnetic stimulation (rTMS) as a supplementary treatment for depression in both major depressive disorder (MDD) and bipolar disorder (BD). Nine consenting patients (MDD = 7; BD = 2) each received 20 accelerated theta-burst sessions over 8 days. Improvement was monitored using the Centre for Epidemiological Studies Depression (CES-D) Scale and the Clinical Global Impression (CGI) Scale at baseline, at day 5 and at day 8 of rTMS treatment. We performed a Wilcoxon matched-pairs signed-rank test to determine whether there was a difference in scores from baseline to post-treatment. The CES-D scores decreased significantly from baseline to post-treatment (Z = -2.547, p = 0.011) with five patients experiencing at least a 50% symptom reduction on the CES-D. CGI severity scores also decreased significantly between baseline and post-treatment (Z = -2.547, p = 0.011). The most commonly reported adverse effect was mild headaches, lasting a few hours during and after rTMS treatment. The findings suggest that the accelerated theta-burst rTMS protocol for depression is well tolerated with most patients also experiencing symptomatic improvement by day 8.
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.