LLTS to Treat Premature Ventricular Contractions

Summary

This randomized control trial is designed to explore the effect of low-level tragus stimulation in patients with frequent premature ventricular contractions.

Conditions

• Premature Ventricular Contraction

Interventions

DEVICE

Low-level tragus stimulation

Frequency: 20Hz; Pulse width: 0.2 ms; Current is based on the following: Determine the perception threshold (feeling tingling) at the time of baseline information assessment. Because of sensory adaptation, ask the patient 5 minutes later to increase the current by 1-5 mA. Try to find the current level below the discomfort level and above the perception threshold; Stimulation spot: ear tragus; Stimulation time: 30 min in the morning (from 6:00 a.m. to 9:00 a.m.) and 30 min in the evening (from 20:00 p.m. to 23:00 p.m.)

DEVICE

Sham stimulation

Frequency: 20 Hz; Pulse width: 0.2 ms; Current is based on the following: Determine the perception threshold (feeling tingling) at the time of baseline information assessment. Because of sensory adaptation, ask the patient 5 minutes later to increase the current by 1-5 mA. Try to find the current level below the discomfort level and above the perception threshold; Stimulate spot: ear lobe. Stimulation time: 30 min in the morning (from 6:00 a.m. to 9:00 a.m.) and 30 min in the evening (from 20:00 p.m. to 23:00 p.m.)

Sponsors & Collaborators

• University of Oklahoma

  collaborator OTHER

• The Affiliated Hospital of Xuzhou Medical University

  collaborator OTHER

• Wuxi No. 2 People's Hospital

  collaborator OTHER

• The First People's Hospital of Changzhou

  collaborator OTHER

• Second Affiliated Hospital of Nantong University

  collaborator OTHER

• Affiliated Hospital of Nantong University

  collaborator OTHER

• Geriatric Hospital of Nanjing Medical University

  collaborator OTHER

• First Affiliated Hospital of Wannan Medical College

  collaborator OTHER

• Jiangsu Taizhou People's Hospital

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-15

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• China

Study Locations