RECRUITING

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

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Conditions

Bipolar Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-09-20
Study Completion:2029-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06274567

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.

Ages Eligible for Study:24 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Individuals of all genders
  2. 2. ages 24-65
  3. 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. 4. Current depressive episode, assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) score ≥20,
  5. 5. Ability to provide informed consent and verifiable contact information, including current psychiatric treatment provider
  6. 6. Stable medication regimen for at least one month, which must include a mood stabilizer
  1. 1. current mania/hypomania assessed by the Young Mania Rating Scale (YMRS \> 12)
  2. 2. rapid-cycling bipolar illness, defined as \>4 episodes per year, indicating increased risk of switch to mania
  3. 3. current active suicidality (suicidal ideation with intent or plan), as assessed by a score \>4 on the MADRS item #10
  4. 4. current substance use disorder for the past 6 months; substance use disorder in remission permitted
  5. 5. history of psychosis
  6. 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. 7. medical illness or non-psychiatric medical treatment that would likely interfere with study participation
  8. 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. 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. 10. current use of benzodiazepines, which can interfere with iTBS stimulation
  11. 11. current pregnancy, to limit potential risks to an unborn child

Contacts and Locations

Study Contact

Kristen K Ellard, PhD
CONTACT
617-724-3221
kellard@mgh.harvard.edu
Christopher Polanco, MS MBA
CONTACT
(617) 643-2776
cjpolanco@mgh.harvard.edu

Principal Investigator

Kristen K Ellard, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Martinos Center for Biomedical Imaging
Charlestown, Massachusetts, 02129
United States
University of Pennsylvania, Center for Neuromodulation in Depression and Stress
Philadelphia, Pennsylvania, 19104-4283(215) 573-4229
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Kristen K Ellard, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-20
Study Completion Date2029-03-31

Study Record Updates

Study Start Date2024-09-20
Study Completion Date2029-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Bipolar Disorder