Effects of Theta Burst Stimulation on the Brain, Behavior, and Clinical Symptoms in Adults with Bipolar Disorder

Description

Bipolar Disorder (BD) is a common and highly debilitating psychiatric disorder, however, the predisposing brain mechanisms are poorly understood. Here, the investigators aim to examine the immediate effect of transcranial brain stimulation (TBS) on brain activity and emotions in adults with and without BD as a first stage toward understanding the predisposing brain mechanisms of BD. The investigators hypothesize that TBS will reduce brain activity while playing a game with rewards in all adults, but the TBS will reduce brain activity more in the adults with BD compared to adults without BD. Furthermore, the investigators hypothesize that this reduced brain activity will be associated with reduced BD symptoms, such as negative emotions.

Conditions

Bipolar Disorder

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Study Overview

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Study Details

Study overview

Bipolar Disorder (BD) is a common and highly debilitating psychiatric disorder, however, the predisposing brain mechanisms are poorly understood. Here, the investigators aim to examine the immediate effect of transcranial brain stimulation (TBS) on brain activity and emotions in adults with and without BD as a first stage toward understanding the predisposing brain mechanisms of BD. The investigators hypothesize that TBS will reduce brain activity while playing a game with rewards in all adults, but the TBS will reduce brain activity more in the adults with BD compared to adults without BD. Furthermore, the investigators hypothesize that this reduced brain activity will be associated with reduced BD symptoms, such as negative emotions.

Elucidating Neural Mechanisms of Hypo/mania Using Theta Burst Stimulation

Effects of Theta Burst Stimulation on the Brain, Behavior, and Clinical Symptoms in Adults with Bipolar Disorder

Condition
Bipolar Disorder
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

University of Pittsburgh, Pittsburgh, Pennsylvania, United States, 15213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. All participants
  • * 18-35 years of age
  • * Scoring less than or equal to 8 on the Hamilton Rating Scale for Depression (HRSD) at screen visit
  • 2. Participants with Bipolar Disorder (BD)
  • * Diagnosis of Bipolar Disorder I/II (BDI/II) (DSM-5 criteria) in remission (euthymic for \>2 months) or with mild-moderate hypomania
  • * \<15 on the Young Mania Rating Scale
  • * Not psychotic
  • * \<3 on delusions, hallucinations, unusual thought content, and conceptual disorganization items of the Positive and Negative Syndrome Scale (PANSS)
  • * Unmedicated or on any combination (except antidepressant monotherapy) of anxiolytics (benzodiazepines, buspirone, pregabalin, hydroxyzine) as needed, and/or atypical antipsychotics, and/or lithium, and/or other mood stabilizers, and/or non-SNRI antidepressants and/or non benzodiazepine hypnotics taken for \>2 months, as these are commonly-prescribed medications for BD
  • 3. Participants without Bipolar Disorder
  • * No present or lifetime history of BD or psychiatric disorder other than anxiety or non BD mood disorders
  • * Not in a current depressive episode
  • * No family history of BD
  • 1. All participants
  • * History of head injury, neurological, pervasive developmental disorder (e.g. autism), systemic medical disease and treatment (medical records, participant report)
  • * Family history of epilepsy (TBS exclusion criterion)
  • * Use of substances with seizure risk (e.g., stimulants) in the past month, assessed as at screening, baseline, and before each fMRI-cTBS-fMRI session
  • * Mini-Mental State Examination score (cognitive state) \<24
  • * Premorbid National Adult Reading Test Intelligent Quotient estimate\<85
  • * Visual disturbance: \<20/40 Snellen visual acuity
  • * Left/mixed handedness
  • * History of alcohol/substance use disorder (SUD; all substances, including nicotine), and/or illicit substance use (except cannabis) over the last 6 months (SCID-5). Note: lifetime/present cannabis use (at non-abuse (\<3 times in the past month) and non SUD levels) will be allowed, given its common usage in BD and young adults. Cannabis SUD over the last 6 months will not be allowed. Urine tests on scan days will exclude current illicit substance use (except cannabis). Salivary alcohol tests on scan days will exclude intoxicated individuals
  • * Binge drinking in the week before, and/or \>3 units/day for the 3 days before, and/or alcohol in the last 12 hrs before, any cTBS scan day, confirmed at screening and scan days (to avoid TBS during alcohol withdrawal). Alcohol/nicotine/ caffeine/cannabis use (below SCID-5 SUD, binge levels) will be allowed, and used as covariates
  • * MRI

Ages Eligible for Study

18 Years to 35 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Mary Phillips, MD MD (Cantab),

Mary Phillips, MD, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Fabio Ferrarelli, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2025-09