Small Fiber Assessment by Cutaneous Silent Period

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.

Study Overview

• Status: Recruiting
• Conditions: Small Fiber Neuropathy
• Intervention / Treatment: Diagnostic test: cutaneous silent period

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 Type: Observational
• Enrollment (Anticipated): 64

Contacts and Locations

• Study Contact: Name: Sarah M Kaddah, MSc; Phone Number: 002 01226444168; Email: SarahKaddah@hotmail.com
• Study Contact Backup: Name: Lamia M Afifi, Professor; Phone Number: 002 01223938134; Email: lafifi2@kasralainy.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 12345
    • Recruiting
    • Medicine
    • Contact: Lamia M Afifi, Professor; Phone Number: 002 01223938134; Email: lafifi2@kasralainy.edu.eg
    • Principal Investigator: Sarah M Kaddah, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Gender: males and females, age group: 20-60, healthy subjects

Description

Inclusion criteria:

• 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

Exclusion criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 year

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Hebatallah R Rashad, Professor, Cairo university; Study Director: Lamia M Afifi, Professor, Cairo university; Study Director: AlShaimaa S Khalil, MD, Cairo university

Publications and helpful links

General 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.
• Onal 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.
• Lopergolo 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.
• Eckert 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 27, 2021
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): October 30, 2021

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 24, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 24, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Small Fiber Neuropathy
• Other Study ID Numbers: Clinical Neurophysiology

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No