Small Fiber NeuropathyNCT04863820
Small Fiber Assessment by Cutaneous Silent Period
An observational study of Small Fiber Neuropathy, run by Cairo University at 1 site in Egypt.
Trial summary
Our primary objective in this study is to investigate the cutaneous silent period (CSP) in normal subjects in the Egyptian population, as it was not carried out before in Egypt. The aim was to carry out the test in our unit to study the appropriate method, technique, and parameters of this new test so that we can… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Small Fiber Neuropathy
- What is being tested?
- cutaneous silent period
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Apr 2021to 30 Oct 2021
- Phase
- Observational
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Gender: males and females, age group: 20-60, healthy subjects
Who may be able to join
- Healthy participants able to cooperate and to follow instructions.
- Participants having a normal value for electrophysiological parameters (Nerve conduction studies)
- Participants must be free from any musculoskeletal impairment of the limbs
Who cannot join
- Participants with neurological disorders
- Participants with cognitive impairment
- Participants receiving medications that may affect the NCS
- Participants with small fiber neuropathy (burning sensation, pricking sensation, allodynia, and hyperalgesia)
- Participants with an abnormal value for Nerve conduction studies
- Participants with musculoskeletal impairment of the limbs
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Medicine
Cairo, 12345
Lamia M Afifi, Professor, 002 01223938134, lafifi2@kasralainy.edu.eg
Sarah M Kaddah, MSc
About this study
Official title: Small Peripheral Fibers Assessment Using Cutaneous Silent Period In Normal Individuals In Egypt
Our primary objective in this study is to investigate the cutaneous silent period (CSP) in normal subjects in the Egyptian population, as it was not carried out before in Egypt. The aim was to carry out the test in our unit to study the appropriate method, technique, and parameters of this new test so that we can apply it in future research. In addition, to obtain preliminary normative data of the test; onset latency, end latency, duration, and latency difference (LD) of CSP, as well as assess the effect of age, height, upper limb length, and gender on CSP values.
Read the detailed description
Nerve conduction studies performed routinely in electromyoneurography laboratories deal mainly with large myelinated fast conducting nerve fibers. A reliable method allowing the study of small peripheral nerve fibers (Aδ \& C) would be of interest (Jovita et al., 2006). As they are initially affected and maybe the earliest exhibited sign of neuropathy.
In recent years, the cutaneous silent period (CSP) has received increased attention in health and disease. The CSP is an inhibitory spinal reflex that appears following strong electrical stimulation of the cutaneous nerve and causes suppression of voluntary muscular contraction for a certain period of time (Kofler et al., 2019). This action presents a reciprocal action to the nociceptive flexor withdrawal response (FWR) which serves as an 'excitatory reflex' increasing activity in primary flexor muscles. When taken into context, the interplay between the CSP and FWR can clearly be seen.
The evaluation of the CSP represents a useful electrophysiological method for investigating the function of small fibers by using standard electromyography equipment (Eckert et al., 2018).
- Conditions
- Small Fiber Neuropathy
- Being tested
- cutaneous silent period
- Medical subject headings
- Small Fiber Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cutaneous silent periodDiagnostic test
form of Nerve conduction studies
What is being measured
The primary outcome is the main question the study is designed to answer.
Normative parameters of cutaneous silent period of the median, ulnar , and sural nerves (measured in milli second)
establishing Normative of CSP enables the diagnosis of small fiber neuriopathy in the future The CSP parameters include: CSP onset latency,CSP end latency, and CSP duration (measured in ms; milli second)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start27 Apr 2021 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Small Fiber NeuropathyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Cross-sectional
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Mostafa Kaddah, Cairo University
- Investigators
- Hebatallah R Rashad, Professor, Study director, Cairo UniversityLamia M Afifi, Professor, Study director, Cairo UniversityAlShaimaa S Khalil, MD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863820
- Sponsor's protocol ID
- Clinical Neurophysiology
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Svilpauskaite J, Truffert A, Vaiciene N, Magistris MR. Electrophysiology of small peripheral nerve fibers in man. A study using the cutaneous silent period. Medicina (Kaunas). 2006;42(4):300-13.
PubMed 16687902Onal MR, Ulas UH, Oz O, Bek VS, Yucel M, Taslipinar A, Odabasi Z. Cutaneous silent period changes in Type 2 diabetes mellitus patients with small fiber neuropathy. Clin Neurophysiol. 2010 May;121(5):714-8. doi: 10.1016/j.clinph.2009.12.024. Epub 2010 Feb 6.
PubMed 20138004Lopergolo D, Isak B, Gabriele M, Onesti E, Ceccanti M, Capua G, Fionda L, Biasiotta A, Di Stefano G, La Cesa S, Frasca V, Inghilleri M. Cutaneous silent period recordings in demyelinating and axonal polyneuropathies. Clin Neurophysiol. 2015 Sep;126(9):1780-9. doi: 10.1016/j.clinph.2014.11.013. Epub 2014 Nov 25.
PubMed 25497713Eckert NR, Poston B, Riley ZA. Differential processing of nociceptive input within upper limb muscles. PLoS One. 2018 Apr 25;13(4):e0196129. doi: 10.1371/journal.pone.0196129. eCollection 2018.
PubMed 29694394
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Peripheral Fibers Assessment Using Cutaneous Silent Period In Normal Individuals In Egypt
- ClinicalTrials.gov ID
- NCT04863820
- Acronym / sponsor ID
- Clinical Neurophysiology
- Conditions
- Small Fiber Neuropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 27 Apr 2021 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 28 Apr 2021 (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.
Our primary objective in this study is to investigate the cutaneous silent period (CSP) in normal subjects in the Egyptian population, as it was not carried out before in Egypt. The aim was to carry out the test in our unit to study the appropriate method, technique, and parameters of this new test so that we can apply it in future research. In addition, to obtain preliminary normative data of the test; onset latency, end latency, duration, and latency difference (LD) of CSP, as well as assess the effect of age, height, upper limb length, and gender on CSP values.
Detailed description
Nerve conduction studies performed routinely in electromyoneurography laboratories deal mainly with large myelinated fast conducting nerve fibers. A reliable method allowing the study of small peripheral nerve fibers (Aδ \& C) would be of interest (Jovita et al., 2006). As they are initially affected and maybe the earliest exhibited sign of neuropathy.
In recent years, the cutaneous silent period (CSP) has received increased attention in health and disease. The CSP is an inhibitory spinal reflex that appears following strong electrical stimulation of the cutaneous nerve and causes suppression of voluntary muscular contraction for a certain period of time (Kofler et al., 2019). This action presents a reciprocal action to the nociceptive flexor withdrawal response (FWR) which serves as an 'excitatory reflex' increasing activity in primary flexor muscles. When taken into context, the interplay between the CSP and FWR can clearly be seen.
The evaluation of the CSP represents a useful electrophysiological method for investigating the function of small fibers by using standard electromyography equipment (Eckert et al., 2018).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Gender: males and females, age group: 20-60, healthy subjects
Key inclusion criteria (3 listed)
- Healthy participants able to cooperate and to follow instructions.
- Participants having a normal value for electrophysiological parameters (Nerve conduction studies)
- Participants must be free from any musculoskeletal impairment of the limbs
Key exclusion criteria (6 listed)
- Participants with neurological disorders
- Participants with cognitive impairment
- Participants receiving medications that may affect the NCS
- Participants with small fiber neuropathy (burning sensation, pricking sensation, allodynia, and hyperalgesia)
- Participants with an abnormal value for 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 |
|---|---|---|
| cutaneous silent periodform of Nerve conduction studies | Diagnostic test | – |
Primary outcome
Normative parameters of cutaneous silent period of the median, ulnar , and sural nerves (measured in milli second)
Time frame: 1 year
establishing Normative of CSP enables the diagnosis of small fiber neuriopathy in the future The CSP parameters include: CSP onset latency,CSP end latency, and CSP duration (measured in ms; milli second)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Background: PubMed 16687902Svilpauskaite J, Truffert A, Vaiciene N, Magistris MR. Electrophysiology of small peripheral nerve fibers in man. A study using the cutaneous silent period. Medicina (Kaunas). 2006;42(4):300-13.
- Background: PubMed 20138004Onal MR, Ulas UH, Oz O, Bek VS, Yucel M, Taslipinar A, Odabasi Z. Cutaneous silent period changes in Type 2 diabetes mellitus patients with small fiber neuropathy. Clin Neurophysiol. 2010 May;121(5):714-8. doi: 10.1016/j.clinph.2009.12.024. Epub 2010 Feb 6.
- Background: PubMed 25497713Lopergolo D, Isak B, Gabriele M, Onesti E, Ceccanti M, Capua G, Fionda L, Biasiotta A, Di Stefano G, La Cesa S, Frasca V, Inghilleri M. Cutaneous silent period recordings in demyelinating and axonal polyneuropathies. Clin Neurophysiol. 2015 Sep;126(9):1780-9. doi: 10.1016/j.clinph.2014.11.013. Epub 2014 Nov 25.
- Background: PubMed 29694394Eckert NR, Poston B, Riley ZA. Differential processing of nociceptive input within upper limb muscles. PLoS One. 2018 Apr 25;13(4):e0196129. doi: 10.1371/journal.pone.0196129. eCollection 2018.
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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.
Hebatallah R Rashad, Professor study director
Cairo University
Lamia M Afifi, Professor study director
Cairo University
AlShaimaa S Khalil, MD study director
Cairo University
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 Small Fiber Neuropathy, run by Cairo University at 1 site in Egypt.
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 6 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: status not confirmed, as of the sponsor's last update on 28 Apr 2021. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah M Kaddah, MSc (002 01226444168, SarahKaddah@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normative parameters of cutaneous silent period of the median, ulnar , and sural nerves (measured in milli second) (time frame: 1 year). 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 NCT04863820, which also lists 4 linked publications.
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 28 Apr 2021.