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TcMS to Treat Ventricular Tachycardia

Sponsor
University of Pennsylvania (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05016921
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
37
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Open label study of transcutaneous magnetic stimulation targeting the stellate ganglion in patients with ventricular tachycardia

Condition or Disease Intervention/Treatment Phase
  • Device: TcMS
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Transcutaneous Magnetic Stimulation of the Stellate Ganglion to Treat Ventricular Tachycardia
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2026
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Transcutaneous magnetic stimulation

Transcutaneous magnetic stimulation targeting the stellate ganglion

Device: TcMS
Transcutaneous magnetic stimulation targeting the stellate ganglion

Outcome Measures

Primary Outcome Measures

  1. Ventricular Tachycardia [0-72 hours after enrollment]

    Burden (number of episodes) of ventricular tachycardia

Secondary Outcome Measures

  1. Non sustained ventricular tachycardia [0-72 hours after enrollment]

    Burden (number of episodes) of ventricular tachycardia

  2. Discomfort [Assessed immediately following stimulation]

    Discomfort experienced during stimulation (on scale of 0-10) reported by patient

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age >18years

  • Documented ventricular tachycardia within the preceding 72 hours

Exclusion Criteria:

  • Pregnancy

  • Implanted ventricular assist device

  • Metal implanted in heard or neck (except the mouth)

  • Implanted medication pumps

  • Cochlear implant

  • Implanted brain stimulator

  • Ocular implant

  • History of malignancy in the region of stimulation (neck)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05016921
Other Study ID Numbers:
  • 849193
First Posted:
Aug 23, 2021
Last Update Posted:
Jan 18, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular

Study Results

No Results Posted as of Jan 18, 2022