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Neurostimulation

Neuromodulation for Treatment-Resistant Depression

N/A
Recruiting
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
Currently diagnosed with Major Depressive Disorder (MDD) or Bipolar Disorder type II and meets criteria for a Major Depressive Episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5)
Medical records confirming a history of moderate to severe treatment-resistance as defined by a score of 7-14 on the Maudsley Staging Method (MSM)
Must not have
Recent (during the current depressive episode) or concurrent use of rapid acting antidepressant agent (i.e., ketamine or a course of ECT)
Contraindication to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1-week post-treatment-initiation

Summary

This trial will study if aiTBS can help people with treatment resistant depression or bipolar disorder who have not responded to other treatments. aiTBS is a new application of repetitive transcranial magnetic stimulation (TMS) that has been shown to help 90% of people with severe, treatment resistant MDD in 1-5 days.

Who is the study for?
This trial is for adults aged 18-80 with treatment-resistant depression, defined by a specific score on the Maudsley Staging Method. Participants must be in good health, have ongoing psychiatric care, and women of childbearing age should use effective contraception. Exclusions include substance abuse issues, recent suicide attempts or ideation, certain neurological diseases or head trauma, metal implants incompatible with MRI or rTMS treatments.
What is being tested?
The study tests an innovative neurostimulation approach called accelerated intermittent theta burst stimulation (aiTBS) targeting different brain regions to alleviate symptoms of severe depression that hasn't responded to standard treatments. It compares active aiTBS at two brain sites versus sham (placebo-like) treatment.
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, headache, lightheadedness, seizures (rare), temporary hearing changes due to noise during treatment sessions and possible emotional changes such as increased anxiety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with MDD or Bipolar II and am currently experiencing a major depressive episode.
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My medical records show I have moderate to severe treatment-resistant depression.
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I have been on a stable antidepressant regimen for 6 weeks and will continue it during the study.
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I am between 18 and 80 years old.
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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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I have used ketamine or had ECT for depression recently.
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I don't have metal in my head, a seizure history, or known brain lesions.
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I have no history of major neurological diseases like dementia, Parkinson's, or brain tumors.
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I've had more than 8 ECT sessions without improvement.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1-week post-treatment-initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1-week post-treatment-initiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in clinician-administered MADRS from Baseline to Week 1 post-treatment-initiation

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Active TBS-DLPFCActive Control1 Intervention
The active group will receive theta-burst TMS stimulation.
Group II: Active TBS-DMPFCActive Control1 Intervention
The active group will receive theta-burst TMS stimulation.
Group III: Sham Comparator: Sham TBS-DLPFC or DMPFCPlacebo Group1 Intervention
The sham group will receive sham theta-burst TMS stimulation.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,472 Previous Clinical Trials
17,501,718 Total Patients Enrolled
David Spiegel, MDPrincipal InvestigatorStanford University
11 Previous Clinical Trials
1,717 Total Patients Enrolled

Media Library

Accelerated Intermittent Theta Burst Stimulation (aiTBS) (Neurostimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05144789 — N/A
Major Depressive Disorder Research Study Groups: Sham Comparator: Sham TBS-DLPFC or DMPFC, Active TBS-DLPFC, Active TBS-DMPFC
Major Depressive Disorder Clinical Trial 2023: Accelerated Intermittent Theta Burst Stimulation (aiTBS) Highlights & Side Effects. Trial Name: NCT05144789 — N/A
Accelerated Intermittent Theta Burst Stimulation (aiTBS) (Neurostimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05144789 — N/A
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT05144789 — N/A
~0 spots leftby Dec 2024
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