NCT04863820

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

April 27, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

April 14, 2021

Last Update Submit

April 24, 2021

Conditions

Small Fiber Neuropathy

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

cutaneous silent periodDIAGNOSTIC_TEST

form of Nerve conduction studies

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicine

Cairo, 12345, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 16687902BACKGROUND

  • 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.

    PMID: 20138004BACKGROUND

  • 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.

    PMID: 25497713BACKGROUND

  • 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.

    PMID: 29694394BACKGROUND

MeSH Terms

Conditions

Small Fiber Neuropathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Hebatallah R Rashad, Professor

    Cairo University

    STUDY DIRECTOR

  • Lamia M Afifi, Professor

    Cairo University

    STUDY DIRECTOR

  • AlShaimaa S Khalil, MD

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Sarah M Kaddah, MSc

CONTACT

002 01226444168SarahKaddah@hotmail.com

Lamia M Afifi, Professor

CONTACT

002 01223938134lafifi2@kasralainy.edu.eg

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Neurophysiology resident

Study Record Dates

First Submitted

April 14, 2021

First Posted

April 28, 2021

Study Start

April 27, 2021

Primary Completion

June 30, 2021

Study Completion

October 30, 2021

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations

EG(1)