TENS in Optimizer(R) Patients

NCT02692690 | Completed Phase 4

• 1 other identifier: 1067_2015
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• The patients with CCM-system are assessed for EMI during TENS-application

  Electromagnetic interference can cause artificial sensing in pacemaker or ICD system. These artefacts may have the effect of suppressing the pacemaker pulses sensing of tachycardia in ICD. The patients will be exposed to electrical stimulations, which will be of different forces on the neck and the upper thigh with r4x. These impulses and the effects will be noted down. It will be investigated if there is an interference with the optimizer ® depending on the different sites of the electrical stimulations and the different impulse forces. Many patients with an Optimizer ® have simultaneously a pacemaker - or ICD implant. A special extra monitor will note if there are probable interferences with these pacemaker- or ICD implants.

  6 months

Study Arms (1)

before-after

EXPERIMENTAL

TENS stimulation neck and thigh

Device: Stimulette r4x

Interventions

Stimulette r4x DEVICE

before-after

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr Michael Wolzt

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 26, 2016
• Study Start: May 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 26, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share