A prospective randomized controlled trial to evaluate two approaches for EEG application on the incidence of electrode-induced skin injury among ambulatory EEG patients

Not Applicable

Completed

• Conditions: Skin injury; Neurological - Epilepsy; Injuries and Accidents - Other injuries and accidents; Skin - Other skin conditions

• Registration Number: ACTRN12620001157965
• Lead Sponsor: Royal Prince Alfred Hospital

Brief Summary

This experimental study among patients undergoing 4-day AEEG monitoring yields the finding that the use of hydrogel electrodes on the frontal and hairless electrode sites reduced inflammation scores compared with the use of a standard protocol of Ten20TM with Tensive® gel. By-group differences were not noted for patient-reported comfort or mood or EEG quality. These findings suggest that the addition of hydrogel electrodes reduces inflammation at frontal electrodes, including GRD electrode sites. However, patient perception regarding comfort and mood was not impacted by the use of hydrogel electrodes. Overall, inflammation levels at electrode sites in both groups were not high. A low overall inflammation level may likely explain the absence of any link between by-group change on inflammation and self-reported comfort and mood. These low inflammation levels found in the present study are very encouraging.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-04
• Study Completion: 2021-06-04
• Last Update Posted: 22 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

All patients are eligible for this study if they are older than 18 years of age and have valid neurologist referrals for AEEG monitoring for four days.

Exclusion Criteria

* Patients have skin irritation/inflammation or headlice on their scalp;
* Patients are allergic to Ten-20 conductive paste, Tensive gel or hydrogel;
* Patients are confused or agitated;
* Patients are unable to tolerate AEEG monitoring;
* Patients are less than 18 or more than 90 years of age.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcomes are to evaluate the effectiveness of the mixed electrode approach using hydrogel electrodes to reduce electrode related skin injury in the patients who require AEEG monitoring for 4 days.<br>The photographs of the patients will be assessed by a skin assessment tool which utilizes skin injury scale: 1= Minimal erythema, 2= Moderate erythema with sharply defined borders, 3= Intense erythema with or without edema, 4= Intense erythema with edema and blistering/erosion.<br><br>[ Baseline (before application of electrodes) and last day (Day 4) of AEEG monitoring];EEG data quality is assessed by EEG quality data scale (0-5, 0 indicates poor EEG recording quality and 5 indicates good EEG recording quality). [Baseline (first day of AEEG monitoring) and last day (Day 4) of AEEG monitoring]

Secondary Outcome Measures

Name	Time	Method
A secondary outcome of interest is tolerability of AEEG monitoring. assessed by providing a survey to the patients on the day of EEG electrode removal. The survey consists of four self-reported questions which seek Likert scale responses.[Baseline (before application of electrodes ) and last day (Day 4) of AEEG monitoring];A secondary outcome of interest is patient mood during AEEG monitoring assessed by providing a survey to the patients on the day of EEG electrode removal. The survey consists of four self-reported questions which seek Likert scale responses.<br><br>[Baseline (before application of electrodes) and last day (Day 4) of AEEG monitoring]