Randomized Assessment of TcMS for VT Storm

NCT ID: NCT05599022

Last Updated: 2025-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-22

Study Completion Date

2028-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ventricular Tachycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Sham Stimulation

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

Group Type PLACEBO_COMPARATOR

Magnetic Stimulation

Intervention Type DEVICE

Transcutaneous Magnetic Stimulation

Low Frequency TcMS

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

Group Type ACTIVE_COMPARATOR

Magnetic Stimulation

Intervention Type DEVICE

Transcutaneous Magnetic Stimulation

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.

Group Type ACTIVE_COMPARATOR

Magnetic Stimulation

Intervention Type DEVICE

Transcutaneous Magnetic Stimulation

Interventions

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Magnetic Stimulation

Transcutaneous Magnetic Stimulation

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Timothy Markman

Role: CONTACT

215-615-4332

Facility Contacts

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Timothy Markman, MD

Role: primary

Other Identifiers

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852176

Identifier Type: -

Identifier Source: org_study_id

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