Rapid Acting TMS for Depression and Suicide Ideation
Recruiting in Palo Alto (17 mi)
Overseen byDavid Spiegel, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
Must not be taking: Cocaine, Amphetamines, Benzodiazepines
Disqualifiers: Epilepsy, Autism, OCD, Anxiety, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This study evaluates the effects of an accelerated schedule of theta-burst stimulation, termed accelerated intermittent theta-burst stimulation (aiTBS), on the neural networks underlying explicit and implicit suicidal cognition in inpatients with major depressive disorder.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants should not have used rapid-acting antidepressants like ketamine for the current depressive episode.
What data supports the effectiveness of the treatment Accelerated Theta Burst Stimulation for depression and suicide ideation?
Research suggests that accelerated intermittent theta burst stimulation (iTBS) can reduce suicidal thoughts and depressive symptoms in people with major depressive disorder. Studies have shown that iTBS can lead to a quick decrease in suicidal ideation, although some effects might be influenced by placebo responses.
12345Is rapid acting TMS safe for humans?
Research shows that accelerated intermittent Theta Burst Stimulation (iTBS), a form of rapid acting TMS, is generally safe and well tolerated in humans, including those with depression and suicidal ideation. Studies have not reported any worsening of symptoms, and side effects are minimal, even with increased stimulation parameters.
26789How is the treatment Accelerated Theta Burst Stimulation (aTBS) different from other treatments for depression and suicide ideation?
Accelerated Theta Burst Stimulation (aTBS) is a unique treatment because it uses rapid, repetitive magnetic pulses to stimulate specific areas of the brain, which may quickly reduce symptoms of depression and suicidal thoughts. Unlike traditional treatments, aTBS can be administered more frequently and in shorter sessions, potentially offering faster relief.
12347Eligibility Criteria
This trial is for adults aged 22-65 with major depressive disorder or bipolar II, experiencing suicidal thoughts. They must be TMS naive, in good health, and agree to use contraception if applicable. Excluded are those with certain mental disorders, substance abuse issues, metal implants or shrapnel in the head, seizures history, severe insomnia or who are pregnant.Inclusion Criteria
Endorse suicidal ideation (score ≥9 on the SSI-M).
I can get rTMS treatment after leaving the hospital.
You have never received Transcranial Magnetic Stimulation (TMS) treatment before.
+9 more
Exclusion Criteria
The principal investigator believes that any other condition or factor could affect the accuracy or integrity of the study data.
I have a history of epilepsy or seizures.
I want ECT and had issues with it before.
+19 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive accelerated theta burst stimulation (aiTBS) or sham stimulation targeting the left dorsolateral prefrontal cortex
1 week
Daily visits (in-person)
Follow-up
Participants are monitored for changes in suicidal ideation and depression severity after treatment
1 week
1 visit (in-person)
Participant Groups
The study tests accelerated intermittent theta-burst stimulation (aiTBS) against a sham treatment to see its effect on brain networks related to suicidal thinking in depressed patients. Participants will receive either real aiTBS or a placebo-like version without active stimulation.
2Treatment groups
Active Control
Placebo Group
Group I: Left Dorsolateral Prefrontal Cortex (L-DLPFC)Active Control1 Intervention
The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (DLPFC)
Group II: Sham StimulationPlacebo Group1 Intervention
Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (DLPFC) region
Accelerated Theta Burst Stimulation is already approved in United States for the following indications:
🇺🇸 Approved in United States as MagVita TMS Therapy System w/Theta Burst Stimulation for:
- Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford HospitalStanford, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
References
Effect of high frequency versus theta-burst repetitive transcranial magnetic stimulation on suicidality in patients with treatment-resistant depression. [2023]To investigate the effect of 10 Hz repetitive transcranial magnetic stimulation (rTMS) and intermittent theta-burst stimulation (iTBS) on suicidality in patients with treatment-resistant depression (TRD).
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.
Suicidality and relief of depressive symptoms with intermittent theta burst stimulation in a sham-controlled randomized clinical trial. [2023]Suicidality is a serious public health problem and is closely associated with the severity of depression. In this work, we examined the effects of accelerated intermittent theta burst stimulation (iTBS) on suicidal status, risk factors for suicide, and severity of depressive symptoms in subjects with major depressive disorder (MDD).
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.
Placebo aiTBS attenuates suicidal ideation and frontopolar cortical perfusion in major depression. [2020]The application of repetitive transcranial magnetic stimulation has been shown to rapidly decrease suicidal ideation in major depressive disorder (MDD). However, the neural working mechanisms behind this prompt attenuation of suicidal thoughts remains to be determined. Here, we examined how placebo-accelerated intermittent theta burst stimulation (aiTBS) may influence brain perfusion and suicidal thoughts using arterial spin labeling (ASL). In a randomized double-blind sham-controlled crossover trial, 45 MDD patients received aiTBS applied to the left dorsolateral prefrontal cortex (Trial registration: http://clinicaltrials.gov/show/NCT01832805 ). With each ASL scan measurement, suicidal ideation was assessed with the Beck Scale for Suicidal Ideation (BSI) and depression severity with the Beck Depression Inventory (BDI). Compared with active stimulation, the attenuation of suicidal ideation after 4 days of placebo aiTBS was related to significant frontopolar prefrontal perfusion decreases. These findings were unrelated to changes in depression severity scores. Although both active and sham aiTBS resulted in prompt decreases in suicidal ideation, specifically sham aiTBS significantly attenuated frontopolar perfusion in relation to reductions in BSI scores. Our findings show that in accelerated neurostimulation paradigms, placebo responses are related to perfusion decreases in brain areas associated with higher cognitive processes, resulting in suicidal ideation attenuation.
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).
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.
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.
Effect of intermittent theta burst stimulation on suicidal ideation and depressive symptoms in adolescent depression with suicide attempt: A randomized sham-controlled study. [2023]Suicidal ideation is a serious symptom of major depressive disorder (MDD). Intermittent theta burst stimulation (iTBS) is a safe, effective brain stimulation treatment for alleviating suicidal ideation in adults with MDD. This study aimed to examine the clinical efficacy of iTBS on reducing suicidal ideation in adolescent MDD with suicide attempt.