Randomized Assessment of TcMS for VT Storm

University of Pennsylvania

Status: Enrolling

Conditions: Ventricular Tachycardia

Treatments: Device: Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05599022

852176

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥3 episodes of sustained VT or appropriate ICD therapies within 24 hours despite the use of at least one antiarrhythmic drug

Exclusion criteria

• Plan for catheter ablation of VT in the next 24 hours
• Pregnancy
• Contraindication to TcMS (i.e. implantable ventricular assist device, metal implanted in the head or neck [except the mouth], implanted medication pumps, cochlear implant, implanted brain stimulator, ocular implant, history of malignancy in the neck)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

Sham Stimulation

Placebo Comparator group

Description:

With the coil directed away from the patient, 600 pulses of TcMS will be delivered at minimal energy output.

Treatment:

Device: Magnetic Stimulation

Low Frequency TcMS

Active Comparator group

Description:

With the coil directed at the stellate ganglion, 60 minutes of 1Hz stimulation will be delivered targeting the stellate ganglion.

Treatment:

Device: Magnetic Stimulation

Theta Burst Stimulation TcMS

Active Comparator group

Description:

With the coil directed at the stellate ganglion, 600 pulses of continuous theta burst stimulation will be delivered targeting the stellate ganglion.

Treatment:

Device: Magnetic Stimulation