TENS in Optimizer(R) Patients

Medical University of Vienna logo

Medical University of Vienna

Status and phase

Completed
Phase 4

Conditions

Heart Failure

Treatments

Device: Stimulette r4x

Study type

Interventional

Funder types

Other

Identifiers

NCT02692690
1067_2015

Details and patient eligibility

About

Systemic skeletal muscle atrophy (cachexia) is a typical side effect of chronic heart failure. Patients with cachexia can benefit from transcutaneous electrical neuromuscular stimulation (TENS). It is applied to strengthen the musculature and improve exercise tolerance and quality of life. It is unclear if application of TENS can cause electromagnetic interference (EMI) in patients with Optimizer® pacemaker systems for improvement of heart failure. This pilot safety study enrolled 6 patients with chronic heart failure and reduced left ventricular ejection fraction. All patients had an Optimizer® pacemaker system implanted for a minimum of 6 months, no patients had any ventricular arrhythmic episode 3 months prior to the study, and all were in clinically stable condition and willing to participate in this study. Neuromuscular stimulation was administered via TENS in 4 different modes (HF, LF, Burst, MF) on the right and left musculus trapezius and on both musculi quadriceps femoris. All patients were tested for EMI without or with cardiac contractility modulation (CCM) delivery of the Optimizer®-system respectively.

Enrollment

6 patients

Sex

Male

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • >18 years, with implantation of the Optimizer ® >6 months ago, clinically stable condition and without any ventricular arrhythmic episode in the last 3 months.

Exclusion criteria

  • Local swelling or edema at the site of stimulation, intolerance to electrical stimulation, or presence of other metallic implants at the site of stimulation

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

before-after
Experimental group
Description:
TENS stimulation neck and thigh
Treatment:
Device: Stimulette r4x

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems