Small Fiber Assessment by Cutaneous Silent Period | NCT04863820

Studies
Small Fiber Assessment by Cutaneous Silent Period

NCT04863820

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Apr 28, 2021Actual

Enrollment

64Estimated

Phase

Not provided

Conditions

Small Fiber Neuropathy

Interventions

cutaneous silent period

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 27, 2021Estimated

Primary Completion Date

Jun 30, 2021Estimated

Completion Date

Oct 30, 2021Estimated

First Submitted Date

Apr 14, 2021

First Submission Date that Met QC Criteria

Apr 24, 2021

First Posted Date

Apr 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2021

Last Update Posted Date

Apr 28, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sarah Mostafa Kaddah, Clinical Neurophysiology resident, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

64Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cutaneous silent period	Diagnostic Test	form of Nerve conduction studies

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sarah M Kaddah, MSc	Contact	002 01226444168		SarahKaddah@hotmail.com
Lamia M Afifi, Professor	Contact	002 01223938134		lafifi2@kasralainy.edu.eg

Overall Officials

Name	Affiliation	Role
Hebatallah R Rashad, Professor	Cairo University	Study Director
Lamia M Afifi, Professor	Cairo University	Study Director
AlShaimaa S Khalil, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medicine	Recruiting	Cairo		12345	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16687902	Background	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.
20138004	Background	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.

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases