Assessment Of Signal Consistency Between Needle And Surface Electrodes In Tibialis Anterıor Muscle: A Pilot Validaton Study

NCT07579923 | Not Yet Recruiting

• 1 other identifier: ROMATEM HOSPITAL-2026
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to evaluate whether surface electrodes can record physiological muscle activity as accurately as the gold-standard needle electrodes in the tibialis anterior muscle using a diagnostic EMG device The aim of this pilot study is to investigate whether muscle activation data, similar to surface electromyography (SEMG), can be obtained by adjusting the measurement and recording parameters of standard Electroneuromyography (EMG) devices used routinely for diagnostic purposes. Although SEMG is considered the gold standard for the objective assessment of muscle activation, its clinical use in our country is limited due to the high cost of specialized hardware and software. In contrast, diagnostic EMG devices are widely available in many healthcare institutions. The research will be conducted on 30 healthy volunteers between the ages of 20 and 60. Participants will undergo lower extremity nerve conduction studies, reflex response measurements, and muscle activation assessments during voluntary isometric contractions of the m. tibialis anterior. Muscle activation will be recorded using the diagnostic EMG device via surface (adhesive and Ag/AgCl coated) electrodes and needle electrodes. The acquired EMG signals will be analyzed in terms of RMS (Root Mean Square), amplitude, and frequency parameters. The procedures performed within the scope of this study are standard practices carried out during routine EMG examinations. The only additional procedure specific to this research is the repetition of muscle activation measurements using different electrode systems. There is no invasive procedure involved in the surface electrode applications, and the needle electrode application will be performed exactly as it is in routine EMG tests. No serious risks are anticipated; rarely, mild pain, redness, or minor bleeding at the needle insertion site may occur. Through this study, diagnostic EMG devices could be utilized more effectively in rehabilitation and treatment monitoring. It is intended to contribute to the reduction of invasive procedures and to establish a scientific foundation for clinical applications regarding the objective evaluation of muscle activation.

Conditions

Healthy Volunteers (HV); Muscle Activation; Electromyography

Keywords

Surface Electrodes; Needle Electrode; Motor Unit Action Potential (MUAP)

Outcome Measures

Primary Outcomes (1)

• Assessment of Muscle Activation Patterns: Mean Amplitude and Duration of Motor Unit Action Potentials (MUAPs) measured via Diagnostic EMG

  Physiological muscle activity of the M. Tibialis Anterior will be recorded using both needle and surface electrodes. The study will assess and compare two key parameters: the mean amplitude (measured in microvolts) and the mean duration (measured in milliseconds) of the recorded signals. All measurements will be conducted using a diagnostic EMG device to evaluate the correlation between invasive and non-invasive recording techniques during a single one-hour assessment. Each participant will perform the task sequentially using three different electrode systems (M. Tibialis Anterior activation): concentric needle electrodes, adhesive surface electrodes, and Ag/AgCl coated cup electrodes. The entire measurement process for each volunteer is expected to be completed within a single one-hour session. Recruitment will remain active until data from 30 eligible healthy volunteers are successfully collected

  At baseline (Day 1)

Study Arms (1)

Healthy Volunteers Group

OTHER

A single group of 30 healthy volunteers receiving sequential/simultaneous EMG recordings using three different electrode types (needle, adhesive surface, and Ag/AgCl cup)

Diagnostic Test: Needle EMG Recording; Diagnostic Test: Adhesive Surface EMG Recording; Diagnostic Test: Ag/AgCl Cup Electrode Recording

Interventions

Needle EMG Recording DIAGNOSTIC_TEST

A standard concentric needle electrode will be inserted into the M. Tibialis Anterior muscle belly. Physiological motor unit potentials will be recorded using a diagnostic EMG device to assess amplitude and duration

Healthy Volunteers Group

Adhesive Surface EMG Recording DIAGNOSTIC_TEST

Disposable self-adhesive surface electrodes will be placed on the skin over the motor point of the M. Tibialis Anterior. Muscle electrical activity will be recorded during voluntary contraction using a diagnostic EMG device

Healthy Volunteers Group

Ag/AgCl Cup Electrode Recording DIAGNOSTIC_TEST

Ag/AgCl coated cup electrodes will be attached to the skin surface of the M. Tibialis Anterior using conductive paste. Muscle signals will be captured to compare with other recording methods

Healthy Volunteers Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• Female and male

You may not qualify if:

• muscle disease
• stroke
• spinal cord injury
• history of disc herniation surgery,
• polyneuropathy-causing diseases (DM, thyroid, etc.)
• professional athletes

Sponsors & Collaborators

• Romatem Bursa Hospital: lead

Central Study Contacts

NERMİN ÇALIŞIR

CONTACT

+905325235116; nermincalisir@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: A group of 30 healthy volunteers who will undergo three different types of EMG recordings (needle, adhesive surface, and Ag/AgCl cup electrodes) on the M. Tibialis Anterior.

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 12, 2026
• Study Start: April 24, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: start date: 1 August 2026 end date: Upon request by other researchers
• Access Criteria: De-identified demographic data of the volunteers, all signals recorded during EMG, and numerical MUAP values will be shared upon request by other researchers by contacting the corresponding investigator via email.