- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06573918
EMG-Assessed Paratonia: A New Approach to Response Inhibition
EMG-Assessed Paratonia: A Novel Approach to Investigating Motor Response Inhibition in Healthy Subjects
Paratonia is the inability to relax muscles during the assessment of muscle tone in the absence of spasticity and parkinsonian rigidity. It can be evaluated qualitatively using clinical scales and objectively through surface electromyography (EMG-assessed paratonia). It is widely accepted that paratonia represents a manifestation of impaired motor response inhibition due to frontal lobe dysfunction.
Traditionally, motor response inhibition has been assessed using experimental protocols such as go/no-go and stop-signal tasks. Research has shown that athletes, particularly those engaged in open-skill sports, demonstrate superior motor response inhibition compared to sedentary individuals. Even amateur athletes exhibit better motor response inhibition than sedentary individuals, though to a lesser extent than professional athletes.
Given that the etiology of paratonia involves a defect in motor response inhibition, it is hypothesized that EMG-assessed paratonia could become a novel approach for evaluating motor response inhibition. The present study was designed to validate this hypothesis. Specifically, we first tested whether EMG-assessed paratonia in healthy subjects can reveal a well-known aspect of motor response inhibition, namely its correlation with the level of physical activity.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Genova, Italy, 16122
- Università degli Studi di Genova
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Sedentary Individuals: Defined as those engaging in less than 16.67 metabolic equivalent of task (MET) hours per week.
Amateur Athletes: Defined as individuals who engage in 16.67 to 25 MET hours per week.
Professional Athletes: Defined as individuals who engage in more than 25 MET hours per week.
Exclusion Criteria:
Presence of any pathology or pain in the flexor or extensor muscles of the arm. Use of muscle stimulants, relaxants, steroids, tobacco, alcohol, or any other drugs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EMG-assessed paratonia group
The study evaluated EMG-assessed paratonia to measure motor response efficiency across three groups of healthy young adults with varying physical activity levels: professional athletes (in both open and closed skills sports), amateurs, and sedentary individuals.
Surface electrodes were placed on the biceps and triceps brachii muscles during passive elbow movements while participants remained relaxed.
EMG activity detected during these movements was used to quantify the level of paratonia, indicating the participants' ability to relax their muscles.
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EMG-assessed paratonia was analyzed and compared to assess motor response efficiency in three groups of healthy young adults with different levels of physical activity: professional athletes engaged in closed and open skills sports, amateurs, and sedentary individuals.
To analyze EMG-assessed paratonia, two surface electrodes were attached to the biceps and triceps brachii muscles during passive flexion-extension movements of the elbow while the participant remained in a state of maximum relaxation.
Any EMG activity detected during these movements was attributed to an inability to relax, thereby reflecting their degree of paratonia.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neuromuscular excitation of the Biceps Brachii (paratonia assessed by EMG) during passive elbow flexion and extension
Time Frame: Throughout the duration of the evaluation, which lasts about 120 seconds
|
Amplitude of electromyography value (Root Mean Square in microvolt) measured for Biceps Brachii muscle
|
Throughout the duration of the evaluation, which lasts about 120 seconds
|
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Neuromuscular excitation of the Triceps Brachii (paratonia assessed by EMG) during passive elbow flexion and extension
Time Frame: Throughout the duration of the evaluation, which lasts about 120 seconds
|
Amplitude of electromyography value (Root Mean Square in microvolt) measured for Triceps Brachii muscle
|
Throughout the duration of the evaluation, which lasts about 120 seconds
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EMG-DINOGMI-2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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