PolyneuropathiesASPIRENCT07725120
Single-Center Study Evaluating the Impact of Age on the Diagnostic Performance of the Sural-to-Radial Sensory Amplitude Ratio in Length-Dependent and Non-Length-Dependent Peripheral Polyneuropathies
An observational study of Polyneuropathies and Electromyography, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
This retrospective single-center observational study will evaluate the impact of age on the diagnostic performance of the sural-to-radial sensory nerve amplitude ratio (SRAR) in patients with length-dependent and non-length-dependent peripheral sensory polyneuropathies. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Polyneuropathies, Electromyography, Diagnostic Techniques
- What is being tested?
- Retrospective Medical Record Review
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with peripheral sensory polyneuropathies evaluated at the Peripheral Neuromuscular Rare Disease Reference Center of Nice University Hospital between January 2013 and July 2026. Patients will be classified into length-dependent or non-length-dependent phenotypes and stratified into predefined age groups for analysis.
Who may be able to join
- Adults aged 18 years or older.
- Diagnosis of peripheral sensory polyneuropathy.
- Classification as length-dependent (LDN) or non-length-dependent (NLDN) based on clinical and electrophysiological findings.
- Available nerve conduction study including sural and radial sensory nerve amplitudes allowing calculation of the SRAR.
- Evaluated at the Peripheral Neuromuscular Rare Disease Reference Center, Nice University Hospital, between January 2013 and July 2026.
Who cannot join
- Missing or incomplete clinical or electrophysiological data preventing SRAR calculation.
- Unclassifiable neuropathy phenotype.
- Technical factors affecting the reliability of nerve conduction studies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Nice
Nice, Alpes Maritimes, 06000
Angela Puma, 0492035435 ext. +33, puma.ar@chu-nice.fr
Abderhmane de Nice, 0492038953 ext. +33, slioui.a@chu-nice.fr
About this study
Official title: Retrospective Single-Center Study Evaluating the Impact of Age on the Diagnostic Performance of the Sural-to-Radial Sensory Amplitude Ratio in Length-Dependent and Non-Length-Dependent Peripheral Polyneuropathies
This retrospective single-center observational study will evaluate the impact of age on the diagnostic performance of the sural-to-radial sensory nerve amplitude ratio (SRAR) in patients with length-dependent and non-length-dependent peripheral sensory polyneuropathies. Clinical and electrophysiological data collected during routine care between January 2013 and July 2026 will be analyzed. Diagnostic performance will be assessed using receiver operating characteristic (ROC) curve analysis across predefined age groups to determine whether age-adjusted SRAR thresholds improve the differentiation between the two polyneuropathy phenotypes.
Read the detailed description
Peripheral sensory polyneuropathies are commonly classified as length-dependent (LDN) or non-length-dependent (NLDN) based on their clinical and electrophysiological features. This distinction is clinically important because it guides etiological investigations and therapeutic management. The sural-to-radial sensory nerve amplitude ratio (SRAR) is an electrophysiological marker that has been proposed to improve the diagnosis of sensory polyneuropathies and to help differentiate LDN from NLDN. Although the SRAR has traditionally been considered independent of demographic characteristics, recent evidence suggests that it decreases with aging, raising concerns about the use of a single diagnostic threshold across all age groups. The impact of age on the diagnostic performance of the SRAR, particularly in patients with non-length-dependent polyneuropathies, remains poorly characterized. This retrospective single-center study will analyze clinical and electrophysiological data from patients evaluated at the Peripheral Neuromuscular Rare Disease Reference Center of Nice University Hospital between January 2013 and July 2026. The study aims to determine whether age-adjusted SRAR thresholds improve the diagnostic discrimination between length-dependent and non-length-dependent peripheral polyneuropathies.
- Conditions
- Polyneuropathies, Electromyography, Diagnostic Techniques
- Being tested
- Retrospective Medical Record Review
- Medical subject headings
- Polyneuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective Medical Record ReviewOther
This observational study involves retrospective collection and analysis of routinely acquired clinical and electrophysiological data from approximately 180 patients with sensory polyneuropathy. Data extracted from medical records include demographic characteristics, clinical diagnosis, and nerve conduction study parameters, including sural and radial sensory nerve action potential amplitudes used to calculate the sural/radial amplitude ratio (SRAR). No additional diagnostic procedures, treatments, or study-specific assessments are performed. All data are obtained from standard clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Patients with peripheral sensory polyneuropathies | Not described Receives: Other: Retrospective Medical Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of the sural-to-radial sensory nerve amplitude ratio (SRAR)
To evaluate the diagnostic performance of the SRAR for differentiating length-dependent (LDN) from non-length-dependent (NLDN) peripheral sensory polyneuropathies according to age group, using receiver operating characteristic (ROC) curve analysis.
Measured: Baseline (retrospective analysis of data collected between January 2013 and July 2026
Secondary outcomes (2)
Age-specific optimal SRAR diagnostic thresholds
To determine the optimal SRAR cutoff values for each predefined age group using the Youden index derived from ROC curve analysis.
Measured: Baseline (retrospective analysis)
Comparison of SRAR values between LDN and NLDN
To compare SRAR values between patients with length-dependent and non-length-dependent peripheral sensory polyneuropathies and to assess the influence of age on these values.
Measured: Baseline (retrospective analysis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolyneuropathiesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725120
- Sponsor's protocol ID
- 26Neuro04
- Acronym
- ASPIRE
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Single-Center Study Evaluating the Impact of Age on the Diagnostic Performance of the Sural-to-Radial Sensory Amplitude Ratio in Length-Dependent and Non-Length-Dependent Peripheral Polyneuropathies
- ClinicalTrials.gov ID
- NCT07725120
- Acronym / sponsor ID
- ASPIRE / 26Neuro04
- Conditions
- Polyneuropathies, Electromyography, Diagnostic Techniques
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Jul 2026 (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.
This retrospective single-center observational study will evaluate the impact of age on the diagnostic performance of the sural-to-radial sensory nerve amplitude ratio (SRAR) in patients with length-dependent and non-length-dependent peripheral sensory polyneuropathies. Clinical and electrophysiological data collected during routine care between January 2013 and July 2026 will be analyzed. Diagnostic performance will be assessed using receiver operating characteristic (ROC) curve analysis across predefined age groups to determine whether age-adjusted SRAR thresholds improve the differentiation between the two polyneuropathy phenotypes.
Detailed description
Peripheral sensory polyneuropathies are commonly classified as length-dependent (LDN) or non-length-dependent (NLDN) based on their clinical and electrophysiological features. This distinction is clinically important because it guides etiological investigations and therapeutic management. The sural-to-radial sensory nerve amplitude ratio (SRAR) is an electrophysiological marker that has been proposed to improve the diagnosis of sensory polyneuropathies and to help differentiate LDN from NLDN. Although the SRAR has traditionally been considered independent of demographic characteristics, recent evidence suggests that it decreases with aging, raising concerns about the use of a single diagnostic threshold across all age groups. The impact of age on the diagnostic performance of the SRAR, particularly in patients with non-length-dependent polyneuropathies, remains poorly characterized. This retrospective single-center study will analyze clinical and electrophysiological data from patients evaluated at the Peripheral Neuromuscular Rare Disease Reference Center of Nice University Hospital between January 2013 and July 2026. The study aims to determine whether age-adjusted SRAR thresholds improve the diagnostic discrimination between length-dependent and non-length-dependent peripheral polyneuropathies.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with peripheral sensory polyneuropathies | – | Other: Retrospective Medical Record Review |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with peripheral sensory polyneuropathies evaluated at the Peripheral Neuromuscular Rare Disease Reference Center of Nice University Hospital between January 2013 and July 2026. Patients will be classified into length-dependent or non-length-dependent phenotypes and stratified into predefined age groups for analysis.
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Diagnosis of peripheral sensory polyneuropathy.
- Classification as length-dependent (LDN) or non-length-dependent (NLDN) based on clinical and electrophysiological findings.
- Available nerve conduction study including sural and radial sensory nerve amplitudes allowing calculation of the SRAR.
- Evaluated at the Peripheral Neuromuscular Rare Disease Reference Center, Nice University Hospital, between January 2013 and July 2026.
Key exclusion criteria (3 listed)
- Missing or incomplete clinical or electrophysiological data preventing SRAR calculation.
- Unclassifiable neuropathy phenotype.
- Technical factors affecting the reliability of nerve conduction studies.
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 |
|---|---|---|
| Retrospective Medical Record ReviewThis observational study involves retrospective collection and analysis of routinely acquired clinical and electrophysiological data from approximately 180 patients with sensory polyneuropathy. Data extracted from medical records include demographic characteristics, clinical diagnosis, and nerve conduction study parameters, including sural and radial sensory nerve action potential amplitudes used to calculate the sural/radial amplitude ratio (SRAR). No additional diagnostic procedures, treatments, or study-specific assessments are performed. All data are obtained from standard clinical care. | Other | Patients with peripheral sensory polyneuropathies |
Primary outcome
Diagnostic performance of the sural-to-radial sensory nerve amplitude ratio (SRAR)
Time frame: Baseline (retrospective analysis of data collected between January 2013 and July 2026
To evaluate the diagnostic performance of the SRAR for differentiating length-dependent (LDN) from non-length-dependent (NLDN) peripheral sensory polyneuropathies according to age group, using receiver operating characteristic (ROC) curve analysis.
2 secondary outcomes
Age-specific optimal SRAR diagnostic thresholds
Time frame: Baseline (retrospective analysis)
Comparison of SRAR values between LDN and NLDN
Time frame: Baseline (retrospective analysis)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polyneuropathies and Electromyography, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 24 Jul 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela Puma (0492035435 ext. +33, puma.ar@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of the sural-to-radial sensory nerve amplitude ratio (SRAR) (time frame: Baseline (retrospective analysis of data collected between January 2013 and July 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2026.