Randomized Assessment of TcMS for VT Storm

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT05599022
Status
Recruiting
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Conditions

  • Ventricular Tachycardia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Magnetic Stimulation — DEVICE
    Transcutaneous Magnetic Stimulation

Study Details

Three-arm randomized clinical trial comparing two strategies of TcMS to sham stimulation in patients with VT storm. The hypothesis of the study is that TcMS will reduce the burden of VT in the 24 hours after randomization compared to sham stimulation and that TcMS with theta burst stimulation (TBS) will be more effective at reducing VT burden than low frequency TcMS.

Key Dates

Start date
May 22, 2023
Status verified
Apr 2026
Primary completion
Jul 31, 2028
Completion
Oct 31, 2028

Study Design

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

Arms

  • Placebo Comparator: Sham Stimulation
    With the coil directed away from the patient, 600 pulses of TcMS will be delivered at minimal energy output.
  • Active Comparator: Low Frequency TcMS
    With the coil directed at the stellate ganglion, 60 minutes of 1Hz stimulation will be delivered targeting the stellate ganglion.
  • Active Comparator: Theta Burst Stimulation TcMS
    With the coil directed at the stellate ganglion, 600 pulses of continuous theta burst stimulation will be delivered targeting the stellate ganglion.

Primary Outcome Measure

VT Burden (24 hours) [ Time Frame: 24 hours after randomization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Timothy Markman, MD

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By research site
Hospital of the University of Pennsylvania· Philadelphia, PA

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