HealthyNCT06573918
EMG-Assessed Paratonia: A New Approach to Response Inhibition
A study testing EMG-based assessment of paratonia in people with Healthy, run by Universita degli Studi di Genova at 1 site in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- EMG-based assessment of paratonia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 18 Apr 2024to 23 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- EMG-based assessment of paratonia
- Keywords
- Electromyography Physical activity, Motor inhibition, Frontal circuits, Sport-specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMG-based assessment of paratoniaDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| EMG-assessed paratonia group | Experimental | 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. Receives: Diagnostic Test: EMG-based assessment of paratonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromuscular excitation of the Biceps Brachii (paratonia assessed by EMG) during passive elbow flexion and extension
Amplitude of electromyography value (Root Mean Square in microvolt) measured for Biceps Brachii muscle
Measured: Throughout the duration of the evaluation, which lasts about 120 seconds
Neuromuscular excitation of the Triceps Brachii (paratonia assessed by EMG) during passive elbow flexion and extension
Amplitude of electromyography value (Root Mean Square in microvolt) measured for Triceps Brachii muscle
Measured: Throughout the duration of the evaluation, which lasts about 120 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start18 Apr 2024
- Primary completion18 Jul 2024
- Study completion23 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita degli Studi di Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Puce, Universita degli Studi di Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573918
- Sponsor's protocol ID
- EMG-DINOGMI-2024
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Puce L, Marinelli L, Curra A, Mori L, Schenone C, Cotellessa F, Tatarelli A, Pucci D, Bragazzi NL, Trompetto C. EMG-assessed paratonia: A novel approach to investigating motor response inhibition in healthy subjects. PLoS One. 2024 Dec 18;19(12):e0315274. doi: 10.1371/journal.pone.0315274. eCollection 2024.
PubMed 39693365
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMG-Assessed Paratonia: A Novel Approach to Investigating Motor Response Inhibition in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06573918
- Acronym / sponsor ID
- EMG-DINOGMI-2024
- Conditions
- Healthy
- Keywords
- Electromyography Physical activity, Motor inhibition, Frontal circuits, Sport-specific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universita degli Studi di GenovaUniversity, hospital or other
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMG-assessed paratonia group | Experimental | Diagnostic Test: EMG-based assessment of paratoniaThe 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMG-based assessment of paratoniaEMG-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. | Diagnostic test | EMG-assessed paratonia group |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Derived from this study: PubMed 39693365Puce L, Marinelli L, Curra A, Mori L, Schenone C, Cotellessa F, Tatarelli A, Pucci D, Bragazzi NL, Trompetto C. EMG-assessed paratonia: A novel approach to investigating motor response inhibition in healthy subjects. PLoS One. 2024 Dec 18;19(12):e0315274. doi: 10.1371/journal.pone.0315274. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMG-based assessment of paratonia in people with Healthy, run by Universita degli Studi di Genova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06573918, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.