What side effects are associated with this type of intervention?

Repetitive transcranial magnetic stimulation (rTMS) for Bipolar Disorder, including high dose spaced theta-burst rTMS, is generally well-tolerated but can cause side effects such as headaches, scalp discomfort, and, rarely, seizures. Other common treatments for Bipolar Disorder include mood stabilizers like lithium, which can cause weight gain, tremors, and thyroid or kidney issues, and antipsychotics like risperidone, which may lead to weight gain, metabolic changes, and extrapyramidal symptoms. It is important to discuss potential side effects with a healthcare provider to tailor the treatment plan to individual needs.

What prior FDA approvals exist?

The FDA has approved several treatments for Bipolar Disorder, including medications such as lithium, valproate, and atypical antipsychotics like quetiapine and olanzapine. Neuromodulation techniques, such as repetitive transcranial magnetic stimulation (rTMS), have also been explored for their efficacy in treating bipolar depression. While rTMS has shown promise in reducing depressive symptoms, its effectiveness for mania remains unclear. High Dose Spaced Theta-Burst rTMS, a specific form of rTMS, is currently being studied for its potential to significantly reduce depressive symptoms in patients with treatment-resistant bipolar depression.

What other types of research exist?

Promising, novel alternatives to High Dose Spaced Theta-Burst rTMS for treating depressive symptoms in Bipolar Disorder patients include: 1) Noninvasive Vagus Nerve Stimulation (nVNS), which has shown potential benefits in neuromodulation; 2) Remote Electrical Neuromodulation devices, which are approved for use and have demonstrated efficacy in related conditions; 3) Electroconvulsive Therapy (ECT), which remains a robust option for treatment-resistant cases; and 4) Pharmacological treatments such as lamotrigine and lithium, which have shown efficacy in managing bipolar depression.

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Repetitive Transcranial Magnetic Stimulation

rTMS for Bipolar Disorder

N/A

Waitlist Available

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Summary

This trial is testing whether a special type of brain stimulation called high dose spaced theta-burst rTMS can help reduce depression in people with bipolar disorder who haven't responded to other treatments. The study will also look for markers in the brain that can predict who will benefit from this treatment. Theta-burst stimulation (TBS) is a newer form of repetitive transcranial magnetic stimulation (rTMS) that has shown similar or greater effects on brain activity compared to standard rTMS.

Who is the study for?

This trial is for adults aged 18-70 with bipolar depression who haven't improved after at least two different treatments. Participants must score at least 20 on the MADRS depression scale, meet DSM 5 criteria for Bipolar I or II, be able to consent, and pass a safety screen for TMS. They should be on stable medication including one mood stabilizer.

What is being tested?

The study tests if high dose spaced theta-burst rTMS can significantly reduce depressive symptoms in bipolar disorder compared to sham treatment over five days. It also aims to identify biomarkers in the brain that could predict remission from bipolar depression after treatment.

What are the potential side effects?

While not explicitly stated here, common side effects of rTMS may include headache, scalp discomfort during stimulation, lightheadedness, and rare risk of seizure; however individual experiences may vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment of Biomarkers

Change in Hamilton Rating Scale for Depression (HRSD-17) Scores

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active iTBSExperimental Treatment1 Intervention

Patients will receive unilateral accelerated theta-burst stimulation to the left dorsal lateral prefrontal cortex for 5 consecutive days, with a total of 10 hours a day. Treatment will be 10min with 50min of breaks in between the 10 sessions.

Group II: Sham iTBSPlacebo Group1 Intervention

Patients will receive sham unilateral accelerated theta-burst stimulation to the left dorsal lateral prefrontal cortex for 5 consecutive days, with a total of 10 hours a day. Treatment will be 10min with 50min of breaks in between the 10 sessions.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Repetitive transcranial magnetic stimulation (rTMS) and electroconvulsive therapy (ECT) are neuromodulation techniques used to treat Bipolar Disorder by targeting specific brain regions to alter neural activity. rTMS uses magnetic fields to stimulate nerve cells in the brain, particularly in the prefrontal cortex, which is associated with mood regulation. ECT involves inducing controlled seizures through electrical currents, which can lead to significant mood improvements. These treatments are particularly relevant for patients who do not respond to traditional pharmacotherapy, such as lithium or antipsychotics, which work by stabilizing mood through neurotransmitter regulation. Understanding these mechanisms helps patients and clinicians make informed decisions about treatment options, especially when conventional medications are ineffective.

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,157 Previous Clinical Trials

1,571,359 Total Patients Enrolled

12 Trials studying Bipolar Disorder

1,888 Patients Enrolled for Bipolar Disorder

Milken InstituteOTHER

7 Previous Clinical Trials

227 Total Patients Enrolled

6 Trials studying Bipolar Disorder

221 Patients Enrolled for Bipolar Disorder

University of PennsylvaniaOTHER

2,053 Previous Clinical Trials

43,013,067 Total Patients Enrolled

5 Trials studying Bipolar Disorder

667 Patients Enrolled for Bipolar Disorder

Media Library

Accelerated Theta Burst Stimulation (Repetitive Transcranial Magnetic Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05393648 — N/A

Bipolar Disorder Research Study Groups: Sham iTBS, Active iTBS

Bipolar Disorder Clinical Trial 2023: Accelerated Theta Burst Stimulation Highlights & Side Effects. Trial Name: NCT05393648 — N/A

Accelerated Theta Burst Stimulation (Repetitive Transcranial Magnetic Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05393648 — N/A

~6 spots leftby Dec 2024

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