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

Part of paid clinical trials in Charlestown, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06274567
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
24 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial Magnetic Stimulation (TMS) — DEVICE
    Transcranial magnetic stimulation (TMS) is a non-invasive tool for modulating patterns of brain activation and circuit connectivity. It uses electromagnetic pulses to induce electric currents over the cortex that serve to depolarize or hyperpolarize neurons, thereby changing patterns of synaptic activity. This study uses intermittent theta burst stimulation (iTBS), an efficient TMS protocol that uses high frequency (50Hz) triplets of TMS given every 200 milliseconds (i.e. at 5 Hz).
  • Sham (placebo) TMS — DEVICE
    Sham stimulation works by blocking the magnetic field with an internal spacer on the sham side of the TMS coil, allowing the operator to place the coil surface against the scalp. A brief electric pulse calibrated to the stimulator output is delivered to the scalp simultaneous to the TMS pulse to mimic the scalp sensation during the sham condition. 75 Importantly, the electric pulse is calibrated to the stimulator output to ensure a realistic sham condition.

Study Details

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.

Key Dates

Start date
Sep 20, 2024
Status verified
Apr 2025
Primary completion
Feb 28, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
136 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active intermittent theta burst stimulation (iTBS)
    The Active intermittent theta burst stimulation (iTBS) arm will receive active iTBS applied to the inferior parietal lobule (IPL)
  • Placebo Comparator: Sham intermittent theta burst stimulation (iTBS)
    The Sham intermittent theta burst stimulation (iTBS) arm will receive sham iTBS applied to the inferior parietal lobule (IPL)

Primary Outcome Measure

Correlated functional magnetic resonance imaging (fMRI) time series (functional connectivity) [ Time Frame: Baseline, 1-3 days post 4-day intervention (up to 4 weeks post Baseline) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Martinos Center for Biomedical ImagingCharlestownMassachusetts02129
Kristen K Ellard, PhD
[email protected]
617-724-3221
Kristen K Ellard, PhD (PRINCIPAL_INVESTIGATOR)
University of Pennsylvania, Center for Neuromodulation in Depression and StressPhiladelphiaPennsylvania19104-4283(215) 573-4229
Yvette Sheline, MD, MS
[email protected]
(215) 573-4229
Walid Makhoul, MD
[email protected]
Yvette Sheline, MD, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charlestown, MA

By condition
Bipolar disorder
By specialty
PsychiatryMental healthBehavioral health
By research site
Martinos Center for Biomedical Imaging· Charlestown, MAUniversity of Pennsylvania, Center for Neuromodulation in Depression and Stress· Philadelphia, PA

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