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Neuromodulation

Accelerated Brain Stimulation for Depression

N/A

Waitlist Available

Led By David Spiegel, 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 18 and 75 years at the time of screening

rTMS/iTBS naive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline (day 0) and at post-inpatient treatment completion (day 2-7)

Awards & highlights

Study Summary

This trial looks at whether a new, accelerated type of brain stimulation called SAINT can help reduce suicidal thoughts in people with major depression.

Who is the study for?

Adults aged 18-75 with major depressive disorder or bipolar II experiencing a current major depressive episode, who have not responded well to previous treatments. Participants must be in good health, avoid pregnancy, caffeine, alcohol and tobacco during the trial. They should also be able to understand English and provide consent.Check my eligibility

What is being tested?

The study is testing an accelerated form of brain stimulation therapy called SAINT against sham (fake) stimulation for its effects on suicidal thoughts in patients with severe depression. The goal is to see if this intensive treatment can change how the brain processes these thoughts.See study design

What are the potential side effects?

Possible side effects from theta-burst stimulation may include discomfort at the stimulation site, headache, lightheadedness, seizures (rare), or temporary hearing changes due to the noise of the machine.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 75 years old.

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I have never had rTMS or iTBS treatments.

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I have been diagnosed with MDD or BAD-II and am currently experiencing a major depressive episode.

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My medical records show I have moderate to severe treatment-resistant condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline (day 0) and at post-inpatient treatment completion (day 2-7)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline (day 0) and at post-inpatient treatment completion (day 2-7)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline (day 0) and at post-inpatient treatment completion (day 2-7) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in the neural network underlying Explicit Suicidal Cognition (ESC) as measured by resting state functional connectivity changes in subgenual anterior cingulate (sgACC) and the default mode network (DMN).

Secondary outcome measures

Change in the neural network underlying Implicit Suicidal Cognition (ISC) as measured by resting state functional connectivity changes in dorsolateral prefrontal cortex (DLPFC) and the anterior cingulate cortex (ACC).

Other outcome measures

Change in the neural networks underlying anhedonia as measured by resting state functional connectivity changes of ACC and DMN.

Neural Networks (Anatomic)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Dorsolateral prefrontal cortexActive 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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,386 Previous Clinical Trials

17,333,908 Total Patients Enrolled

Nolan Williams, MDStudy DirectorStanford University

16 Previous Clinical Trials

1,132 Total Patients Enrolled

David Spiegel, MDPrincipal InvestigatorStanford University

10 Previous Clinical Trials

1,637 Total Patients Enrolled

Media Library

Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) (Neuromodulation) Clinical Trial Eligibility Overview. Trial Name: NCT03693105 — N/A

Major Depressive Disorder Research Study Groups: Sham stimulation, Dorsolateral prefrontal cortex

Major Depressive Disorder Clinical Trial 2023: Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) Highlights & Side Effects. Trial Name: NCT03693105 — N/A

Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) (Neuromodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03693105 — N/A

Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT03693105 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the medical trial permit individuals over 45 years old to participate?

"The eligibility criterion of this medical trial necessitates that potential participants must be above 18 and below 75 years old."

Answered by AI

Are people still eligible to apply for this research experiment?

"Data hosted on clinicaltrials.gov indicates that this trial has concluded its recruitment process, which first began on November 7th 2021 and was last updated May 5th 2022. While the current investigation is no longer looking for applicants, there are still 978 other trials seeking participation at present."

Answered by AI

Could I potentially be eligible for enrollment in this medical research?

"To qualify for enrollment in this trial, potential participants should possess psychosis and be aged between 18-75. There is a need to recruit 100 applicants total."

Answered by AI