Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID05849402

Accelerated Intermittent Theta-Burst Stimulation (aiTBS) in Treatment-Resistant Depression of Bipolar II Disorder

Led by Stanford University · Updated on 2024-04-30

60

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the use of accelerated intermittent theta-burst transcranial magnetic stimulation (aiTBS) to reduce depressive symptoms in individuals with treatment-resistant depression due to bipolar II disorder. This double-blind, randomized, sham-controlled trial focuses on stimulating a specific area of the brain called the left dorsolateral prefrontal cortex (LDLPFC) and aims to understand changes in brain connectivity related to treatment response. Participants will receive 10 aiTBS sessions daily over 5 consecutive days, targeting the LDLPFC using the MagPro rTMS system. They will be randomly assigned to either active aiTBS or sham (placebo) aiTBS groups. Before and after treatment, brain imaging (MRI), EEG, and heart rate variability measurements will be taken to assess brain function and treatment effects. During the study, participants' depressive symptoms will be measured using clinician-rated and self-report scales, including the Montgomery Asberg Depression Rating Scale (MADRS) at baseline, immediately post-treatment, and one month later. Researchers will also monitor mania symptoms and functional brain connectivity changes. The study includes thorough health assessments and safety monitoring through the treatment period.

CONDITIONS

Brief Title

Accelerated Intermittent Theta-Burst Stimulation (aiTBS) in Treatment-Resistant Depression of Bipolar II Disorder

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 80 years
  • Diagnosis of bipolar II disorder with a current major depressive episode as defined by DSM-V
  • Able to understand and provide written informed consent
  • Maudsley Staging Method score of 7 or higher
  • Not currently experiencing hypomania or psychosis
  • In good general health
  • Have a stable psychiatrist confirming diagnosis
  • On a mood stabilizer regimen for at least 6 weeks prior and agree to continue it
  • Montgomery Asberg Depression Rating Scale (MADRS) score of 20 or higher at screening
  • TMS naive
  • For females of reproductive potential, use highly effective contraception for at least 1 month before and during the study
  • Agree to lifestyle considerations including abstaining from pregnancy and alcohol before sessions
Not Eligible

You will not qualify if you...

  • Primary diagnosis other than bipolar II disorder
  • Structural neurological conditions or lesions affecting study safety or results
  • Metal implants in brain, pacemaker, or cochlear implants
  • History of epilepsy or seizures
  • Ferromagnetic items in the head
  • Pregnancy
  • Autism Spectrum Disorder
  • Physical conditions that increase risk or affect study results
  • Active substance abuse or intoxication
  • Cognitive impairment or dementia
  • Severe insomnia
  • Current hypomania or psychosis
  • Withdrawal symptoms from alcohol or benzodiazepines
  • Intellectual disability
  • Movement disorders interfering with treatment
  • Active suicidal ideation or recent suicide attempts
  • History of psychosurgery for depression
  • Extensive history of ECT without response
  • Recent or concurrent use of rapid-acting antidepressants
  • Cardiac history such as myocardial infarction or heart failure
  • Prominent anxiety, personality disorder, or dysthymia
  • Intractable migraine
  • Hypomania in past 6 months
  • aiTBS treatment dose over 65% maximum stimulator output
  • Unstable symptoms between screening and baseline
  • Any other condition deemed unsafe or interfering by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 5 days

Participants receive accelerated intermittent theta-burst stimulation (aiTBS) to the left dorsolateral prefrontal cortex over 5 consecutive days.

Daily visits for 5 days with 10 aiTBS sessions each day

Follow-up

Duration - 1 month

Participants undergo assessments including MRI, EEG, heart rate variability, and depression rating scales to evaluate treatment effects.

Visits immediately post-treatment and at 1 month

Trial Site Locations

Total: 1 location

1

Stanford University

Palo Alto, California, United States, 94305

Actively Recruiting

Loading map...

Research Team

N

Nick Bassano, MSW

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

A Double-blinded, Randomized Placebo-controlled Trial of 40 ...

Major Depressive Disorder

Actively Recruiting

1 location

A Prospective, Multi-center, Randomized Controlled Blinded T...

Treatment Resistant Depression

Actively Recruiting

98 locations

A Global Prospective, Multi-Center, Observational Post-Marke...

Treatment Resistant Depression

Actively Recruiting

18 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial.

Daniel M Blumberger, Fidel Vila-Rodriguez, Kevin E Thorpe...

https://pubmed.ncbi.nlm.nih.gov/29726344

Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of acute treatment outcomes in clinical practice.

Linda L Carpenter, Philip G Janicak, Scott T Aaronson...

https://pubmed.ncbi.nlm.nih.gov/22689344

Efficacy of transcranial magnetic stimulation targets for depression is related to intrinsic functional connectivity with the subgenual cingulate.

Michael D Fox, Randy L Buckner, Matthew P White...

https://pubmed.ncbi.nlm.nih.gov/22658708