Neuromodulation for Enhancement of Emotion Regulation in Bipolar Mood Disorders
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bipolar Disorder
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: There will be a healthy control group and a bipolar disorder group. The bipolar disorder group will then be randomized to one of three conditions.Masking: Single (Participant)Masking Description: Masking will be implemented using a active-placebo TMS coil.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 22 years and 55 years
- Gender
- Both males and females
Description
The objective of this study protocol is to test whether intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to ventrolateral prefrontal cortex (VLPFC) can improve performance on emotion regulation tasks in patients with bipolar disorder. Results from this study will help inform fut...
The objective of this study protocol is to test whether intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to ventrolateral prefrontal cortex (VLPFC) can improve performance on emotion regulation tasks in patients with bipolar disorder. Results from this study will help inform future treatment development to improve emotion regulation in patients with bipolar disorder. The study will proceed in two phases: During Phase 1, a cohort of 30 healthy control subjects will be recruited in order to establish a normative sample from which to compare patient data. Functional magnetic resonance imaging (fMRI) data will be collected from healthy control participants during performance on two emotion regulation tasks (probing implicit and explicit emotion regulation). Data from these subjects will provide a normative distribution of VLPFC function from which to compare individual patients. During Phase 2, a cohort of 60 patients diagnosed with bipolar disorder will be recruited. Patient participants will perform the same two emotion regulation tasks during fMRI scanning. Data from individual patients will be analyzed to detect specific VLPFC subregions showing activation deviations from healthy controls (Phase 1 data). Patient-specific VLPFC subregions showing patterns of activation greater than two standard deviations from healthy controls will be used as individualized target sites for TMS stimulation. Patients will then be randomized to receive either low-dose iTBS-TMS (600 pulses; n=20), high-dose iTBS-TMS (1800 pulses; n=20), or sham iTBS-TMS (n=20). Post-TMS fMRI scans will be acquired during performance on identical implicit and explicit emotion regulation tasks from baseline. Effects of iTBS-TMS on emotion regulation will be evaluated by comparing pre-TMS versus post-TMS behavior, neural activation, and functional connectivity patterns during performance on implicit and explicit emotion regulation tasks.
Tracking Information
- NCT #
- NCT04284267
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Kristen Ellard, PhD Massachusetts General Hospital
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