Neuromodulation of Mood Switch Circuitry in Bipolar Disorder

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT07680153
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Bipolar 1 Depression
  • Bipolar Disorder (BD)
  • fMRI
  • rTMS

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • MagVenture MagPro TMS system — DEVICE
    TANS-guided SAL Acc iTBS approach: Targeted Functional Network Stimulation (TANS) combines precision functional mapping (PFM) with electric field (E-field) modeling to individualize circuit targeting. Active rTMS will be intermittent theta burst simulation (iTBS) delivered to the salience network (SAL) with an accelerated intervention protocol (up to 5 consecutive days of 10 hourly active rTMS sessions).
  • Sham Stimulation — DEVICE
    An Active/Placebo (A/P) sham TMS coil will be used to deliver placebo stimulation. The A/P coil is a double-sided coil in which one side delivers effective magnetic stimulation, while the opposite side is configured to produce a sham condition without inducing cortical activation. Sham stimulation will also be delivered to the salience network (SAL) with an accelerated intervention protocol (up to 5 consecutive days of 10 hourly sham rTMS sessions).

Study Details

This study is exploring a new approach to treating depression in people with bipolar disorder (BD). Investigators are testing whether a non-invasive form of brain stimulation can help us understand depressed-to-euthymic mood shifts and their related brain circuits in BD. Investigators in this study will use a technique called repetitive transcranial magnetic stimulation, or rTMS. It uses non-invasive magnetic pulses delivered to the scalp to stimulate specific areas of the brain. rTMS is already used to treat depression, and investigators are now studying whether it can be made even more effective for people with bipolar disorder by precisely targeting an individualized brain region for each participant. Participants in this study will receive two courses of rTMS, one active and one placebo (called "sham"), in a randomized order so investigators can directly compare the effects. Before treatment, investigators will use brain scans (MRI) to create a personalized map of each participant's brain activity. This lets investigators identify the exact stimulation target most likely to influence the brain circuits involved in BD mood shifts. Investigators will track mood symptoms closely throughout the study to measure what changes. Investigators believe that depression in BD is partly driven by disrupted communication between two brain regions involved in processing what feels important or rewarding. Investigators want to find out whether rTMS can restore that communication and whether doing so leads to measurable improvements in depression.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Active rTMS followed by Sham rTMS
    Active rTMS administered during Intervention Phase 1; Sham rTMS (no active TMS pulses) administered during Intervention Phase 2. Participants will undergo two 5-day rTMS intervention phases (5 days of active stimulation followed by 5 days of sham stimulation) separated by a variable 4-12 week washout period.
  • Experimental: Sham rTMS followed by Active rTMS
    Sham rTMS (no active TMS pulses) administered during Intervention Phase 1; Active rTMS administered during Intervention Phase 2. Participants will undergo two 5-day rTMS intervention phases (5 days of sham stimulation followed by 5 days of active stimulation) separated by a variable 4-12 week washout period.

Primary Outcome Measure

Change from Baseline to 1-Week Post-rTMS in Montgomery-Asberg Depression Rating Scale (MADRS) Score [ Time Frame: Baseline to 1-week post-rTMS ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10065
Research Coordinator, Interventional Psychiatry Program
[email protected]
646-962-2900
Immanuel Elbau, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Weill Cornell Medicine· New York, NY

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