Intermittent Theta Burst Stimulation (iTBS) for Emotion Regulation in Bipolar Disorder

Description

The objective of this study protocol is to test whether intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) can strengthen functional connectivity with a key region in emotion regulation (ER) neurocircuitry (anterior insula, AI) and improve performance on ER-related tasks in patients with bipolar disorder. Individual IPL sites for stimulation will be identified through baseline, pre-TMS functional magnetic resonance imaging (fMRI) scans. Patient-specific IPL subregions showing positive functional connectivity with the anterior insula and falling within the patient-specific frontoparietal control network will be used as individualized target sites for TMS stimulation. Patients will be randomized to receive 24 sessions of active versus sham iTBS to patient-specific IPL targets (6 sessions/day, 4 days, 43,200 pulses total). Post-iTBS resting-state and task-based fMRI scans will be acquired 3 days after the final day of iTBS administration (Day 4) following identical procedures as baseline. Effects of iTBS-TMS on ER will be evaluated by comparing pre-TMS versus post-TMS functional connectivity and behavior during performance on ER tasks.

Conditions

Bipolar Disorder

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Study Overview

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Study Details

Study overview

The objective of this study protocol is to test whether intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) can strengthen functional connectivity with a key region in emotion regulation (ER) neurocircuitry (anterior insula, AI) and improve performance on ER-related tasks in patients with bipolar disorder. Individual IPL sites for stimulation will be identified through baseline, pre-TMS functional magnetic resonance imaging (fMRI) scans. Patient-specific IPL subregions showing positive functional connectivity with the anterior insula and falling within the patient-specific frontoparietal control network will be used as individualized target sites for TMS stimulation. Patients will be randomized to receive 24 sessions of active versus sham iTBS to patient-specific IPL targets (6 sessions/day, 4 days, 43,200 pulses total). Post-iTBS resting-state and task-based fMRI scans will be acquired 3 days after the final day of iTBS administration (Day 4) following identical procedures as baseline. Effects of iTBS-TMS on ER will be evaluated by comparing pre-TMS versus post-TMS functional connectivity and behavior during performance on ER tasks.

Targeting Emotion Regulation in Bipolar Disorder with Intermittent Theta Burst Stimulation: a Mechanistic Study

Intermittent Theta Burst Stimulation (iTBS) for Emotion Regulation in Bipolar Disorder

Condition
Bipolar Disorder
Intervention / Treatment

-

Contacts and Locations

Charlestown

Martinos Center for Biomedical Imaging, Charlestown, Massachusetts, United States, 02129

Philadelphia

University of Pennsylvania, Center for Neuromodulation in Depression and Stress, Philadelphia, Pennsylvania, United States, 19104-4283(215) 573-4229

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. Individuals of all genders
  • 2. ages 24-65
  • 3. Diagnostic Statistical Manual (DSM-5) defined diagnosis of bipolar I or II disorder (BD); assessed using the Mini-International Neuropsychiatric Interview (M.I.N.I.) version 7.0.2.
  • 4. Current depressive episode, assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) score ≥20,
  • 5. Ability to provide informed consent and verifiable contact information, including current psychiatric treatment provider
  • 6. Stable medication regimen for at least one month, which must include a mood stabilizer
  • 1. current mania/hypomania assessed by the Young Mania Rating Scale (YMRS \> 12)
  • 2. rapid-cycling bipolar illness, defined as \>4 episodes per year, indicating increased risk of switch to mania
  • 3. current active suicidality (suicidal ideation with intent or plan), as assessed by a score \>4 on the MADRS item #10
  • 4. current substance use disorder for the past 6 months; substance use disorder in remission permitted
  • 5. history of psychosis
  • 6. dementia or other major neurological disorders, as assessed by a Mini-Mental State Exam (MMSE) score \<24 and Montreal Cognitive Assessment (MOCA) score \<26
  • 7. medical illness or non-psychiatric medical treatment that would likely interfere with study participation
  • 8. contraindications for magnetic resonance imaging (MRI) or transcranial magnetic stimulation (TMS), including the presence of metallic implants that would interfere with safety (i.e. cardiac pacemaker, metal plates, non-removable body piercings, etc.), history of seizure disorder, history of head trauma
  • 9. a clinical course of a neuromodulatory therapy (e.g. transcranial magnetic stimulation, transcranial direct current stimulation, electroconvulsive therapy) within the past 6 months
  • 10. current use of benzodiazepines, which can interfere with iTBS stimulation
  • 11. current pregnancy, to limit potential risks to an unborn child

Ages Eligible for Study

24 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Kristen K Ellard, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

2029-03-31