Theta Burst Stimulation for Depression and Autism

(RETSORE-RCT Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Rana Elmaghraby, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Children's Hospital Medical Center, Cincinnati

Must not be taking: Anticonvulsants, Barbiturates, Lithium, Benzodiazepines

Disqualifiers: Substance use disorder, Epilepsy, others

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)

Will 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 anticonvulsant, barbiturate, lithium, or benzodiazepine medications, you cannot participate in the trial.

What data supports the effectiveness of the treatment Theta Burst Stimulation for depression and autism?

Research shows that Theta Burst Stimulation (TBS), a type of transcranial magnetic stimulation (TMS), can be effective for major depressive disorder (MDD). Some studies suggest that different TBS protocols, like intermittent TBS (iTBS) and continuous TBS (cTBS), have shown promise in treating depression, although results can vary. ^{1 2 3 4 5}

Is theta burst stimulation (TBS) safe for humans?

Research shows that theta burst stimulation (TBS) is generally safe and well-tolerated in humans, with most side effects being mild. However, there is a small risk of seizures, so it should be used with caution. ^{5 6 7 8 9}

How is Theta Burst Stimulation (TBS) different from other treatments for depression and autism?

Theta Burst Stimulation (TBS) is a unique form of transcranial magnetic stimulation (TMS) that uses rapid bursts of magnetic pulses to modulate brain activity, potentially offering a faster and more targeted approach compared to traditional repetitive TMS (rTMS). It is being explored for its effectiveness in treating depression and autism, with some studies suggesting it may enhance the effects of existing treatments like medication and psychotherapy. ^{1 2 3 4 5}

Research Team

Rana Elmaghraby, MD

Principal Investigator

Cincinnati Childrens Hospital Medical Center

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

Fluent in English and able to volunteer in the informed consent process and provide spontaneous narrative description of key elements, risks, and benefits of the study

Full-scale intelligence quotient ≥ 70

I am between 13 and 26 years old.

Exclusion Criteria

Actively suicidal (i.e., suicidal ideation with plan and intent) or deemed at high risk for suicide

I have previously undergone rTMS treatment.

For female subjects of childbearing potential, a positive urine pregnancy test

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive either active or sham accelerated theta burst stimulation (aTBS) targeting the left dorsolateral prefrontal cortex, 5 sessions per day for 5 days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 2-week, 6-week, and 12-week intervals

12 weeks

3 visits (in-person)

Open-label extension (optional)

Participants in the sham group who do not show a significant treatment response by the 12-week follow-up are eligible for active, open-label treatment

Treatment Details

Interventions

• Theta Burst Stimulation (Other)

Trial Overview 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.

Participant Groups

Group I: Active TBS Treatment Active Control 1 Intervention

Active aTBS targeting the left dorsolateral prefrontal cortex, 5 sessions per day for 5 days.

Group II: Sham controlled Placebo Group 1 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Cincinnati Childrens Hospital Medical Center Cincinnati, OH

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Patients Recruited

6,566,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of major depression with bilateral theta burst stimulation: a randomized controlled pilot trial. Plewnia, C., Pasqualetti, P., Große, S., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probing changes in corticospinal excitability following theta burst stimulation of the human primary motor cortex. Goldsworthy, MR., Vallence, AM., Hodyl, NA., et al.[2017]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive continuous theta burst stimulation for major depressive disorder or bipolar depression: A meta-analysis of randomized controlled studies. Cai, DB., Qin, XD., Qin, ZJ., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-dependence of changes in cortical protein expression induced with repeated transcranial magnetic theta-burst stimulation in the rat. Volz, LJ., Benali, A., Mix, A., et al.[2016]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged intermittent theta burst stimulation in the treatment of major depressive disorder: a case series. Richard, M., Noiseux, C., Desbeaumes Jodoin, V., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of theta burst stimulation vs. single and paired pulse transcranial magnetic stimulation: a comparative study of 165 pediatric subjects. Hong, YH., Wu, SW., Pedapati, EV., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. Oberman, L., Edwards, D., Eldaief, M., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The acute effects of accelerated repetitive Transcranial Magnetic Stimulation on suicide risk in unipolar depression: preliminary results. Desmyter, S., Duprat, R., Baeken, C., et al.[2022]

Theta-burst transcranial magnetic stimulation (TBS) is safe and well tolerated in patients with major depression, based on a study involving 33 participants over 10 consecutive days.

The study suggests that TBS may have antidepressant effects, and increasing stimulation parameters does not lead to more side effects, potentially enhancing its therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, tolerability and preliminary evidence for antidepressant efficacy of theta-burst transcranial magnetic stimulation in patients with major depression. Chistyakov, AV., Rubicsek, O., Kaplan, B., et al.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment of major depression with bilateral theta burst stimulation: a randomized controlled pilot trial. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Probing changes in corticospinal excitability following theta burst stimulation of the human primary motor cortex. [2017]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Adjunctive continuous theta burst stimulation for major depressive disorder or bipolar depression: A meta-analysis of randomized controlled studies. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Dose-dependence of changes in cortical protein expression induced with repeated transcranial magnetic theta-burst stimulation in the rat. [2016]

5. Ireland pubmed.ncbi.nlm.nih.gov

Prolonged intermittent theta burst stimulation in the treatment of major depressive disorder: a case series. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and tolerability of theta burst stimulation vs. single and paired pulse transcranial magnetic stimulation: a comparative study of 165 pediatric subjects. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. [2022]

8. Croatia pubmed.ncbi.nlm.nih.gov

The acute effects of accelerated repetitive Transcranial Magnetic Stimulation on suicide risk in unipolar depression: preliminary results. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Safety, tolerability and preliminary evidence for antidepressant efficacy of theta-burst transcranial magnetic stimulation in patients with major depression. [2019]