Intermittent Theta Burst Stimulation (iTBS) for Emotion Regulation in Bipolar Disorder
Recruiting · NCT06274567 · Interventional (participants receive a specific treatment) · Lead sponsor: Massachusetts General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Individuals of all genders
- ages 24-65
- 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.
- Current depressive episode, assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) score ≥20,
- Ability to provide informed consent and verifiable contact information, including current psychiatric treatment provider
- Stable medication regimen for at least one month, which must include a mood stabilizer
Exclusion criteria
- current mania/hypomania assessed by the Young Mania Rating Scale (YMRS \> 12)
- rapid-cycling bipolar illness, defined as \>4 episodes per year, indicating increased risk of switch to mania
- current active suicidality (suicidal ideation with intent or plan), as assessed by a score \>4 on the MADRS item #10
- current substance use disorder for the past 6 months; substance use disorder in remission permitted
- history of psychosis
- dementia or other major neurological disorders, as assessed by a Mini-Mental State Exam (MMSE) score \<24 and Montreal Cognitive Assessment (MOCA) score \<26
- medical illness or non-psychiatric medical treatment that would likely interfere with study participation
- 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
- a clinical course of a neuromodulatory therapy (e.g. transcranial magnetic stimulation, transcranial direct current stimulation, electroconvulsive therapy) within the past 6 months
- current use of benzodiazepines, which can interfere with iTBS stimulation
- current pregnancy, to limit potential risks to an unborn child
- ther: Given that \>86% of BD patients experience lifetime comorbid anxiety, co-occurring anxiety disorders will be allowable for inclusion, thus providing a more representative sample of bipolar patients who typically present at our Clinics for treatment. Comorbid anxiety disorders are not a criteria for inclusion or exclusion.
Where it is running
2 locations listed across 2 US states.
- Martinos Center for Biomedical Imaging - Charlestown, Massachusetts, United States
- University of Pennsylvania, Center for Neuromodulation in Depression and Stress - Philadelphia, Pennsylvania, United States