Randomized Assessment of TcMS for VT Storm

Randomized Assessment of the Efficacy of Transcutaneous Magnetic Stimulation in Patients With Ventricular Tachycardia Storm

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05599022

Enrollment

Registered

2022-10-31

Start date

2023-05-22

Completion date

2028-09-30

Last updated

2025-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Tachycardia

Brief summary

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.

Interventions

DEVICEMagnetic Stimulation

Transcutaneous Magnetic Stimulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
VT Burden (24 hours)	24 hours after randomization	Number of episodes of sustained ventricular tachycardia

Secondary

Measure	Time frame	Description
Freedom from VT	24 hours after randomization	Freedom from sustained VT
Blood Pressure	Immediately before and after stimulation	Change in mean arterial blood pressure
Heart Rate	Immediately before and after stimulation	Change in heart rate
VT burden (72 hours)	72 hours after randomization	Number of episodes of sustained ventricular tachycardia
Lead sensing	Immediately before and after stimulation	Change in implantable device lead sensing
Lead threshold	Immediately before and after stimulation	Change in implantable device lead pacing threshold
Lead impedance	Immediately before and after stimulation	Change in implantable device lead pacing impedance
Pain	Immediately after stimulation	Pain at site of stimulation (0-10 scale)

Countries

United States

Contacts

Primary ContactTimothy Markman

timothy.markman@pennmedicine.upenn.edu215-615-4332

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026