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Non-invasive Brain Stimulation

rTMS for Depression

N/A

Recruiting

Led By Nolan Williams, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Male or Female, between the ages of 22 and 65 at the time of screening

Male or Female, between the ages of 22 and 65 at the time of screening.

Must not have

Depth-adjusted aiTBS treatment dose > 65% maximum stimulator output (MSO)

Untreated or insufficiently treated endocrine disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline (pre-intervention), during the intervention and immediately after the intervention.

Summary

This trial looks at whether a new kind of brain stimulation called "aiTBS" can help people with borderline personality disorder who also have depression.

Who is the study for?

Adults aged 22-65 with Borderline Personality Disorder and a current depressive episode, who are in good health, TMS naive, agree to lifestyle guidelines, use effective contraception if applicable, can understand English for assessments/interventions. Excludes pregnant individuals or those with mania/psychosis, substance abuse issues, certain medical conditions like metal implants incompatible with MRI or history of seizures.

What is being tested?

The trial tests an accelerated form of theta-burst stimulation (aiTBS) on the brain's left dorsolateral prefrontal cortex and dorsomedial prefrontal cortex versus sham stimulation. It aims to assess aiTBS's effectiveness in alleviating depression symptoms in participants with BPD during a depressive episode.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, headache, lightheadedness, temporary hearing changes due to the noise of the machine. Rarely there could be seizure risk or more severe headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 22 and 65 years old.

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I am between 22 and 65 years old.

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I have been diagnosed with MDD, BAPD II, or unspecified depressive disorder and Borderline Personality Disorder.

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I have never undergone TMS therapy.

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I have never undergone TMS therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My treatment's intensity is more than 65% of the maximum level.

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I have a hormone disorder that hasn't been treated enough.

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I have used ketamine or had ECT for depression recently.

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I am currently experiencing mania or psychosis.

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I have a history of serious brain or nerve conditions.

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I've had more than 8 ECT sessions without improvement.

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I have been diagnosed with obsessive-compulsive disorder.

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I do not have metal implants in my head, a history of seizures, or known brain lesions.

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I have been diagnosed with Bipolar I Disorder or a primary psychotic disorder.

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I sleep at least 5 hours each night.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline (pre-intervention), during the intervention and immediately after the intervention.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline (pre-intervention), during the intervention and immediately after the intervention.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline (pre-intervention), during the intervention and immediately after the intervention. for reporting.