NCT05721040

Brief Summary

SARS-COV-2 infection reframed medical knowledge in many aspects, yet there is still a lot to be discovered. our aim is to evaluate neurological impact of covid-19; if there is any.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

February 7, 2023

Last Update Submit

February 7, 2023

Conditions

Motor NeuropathySensory Neuropathy

Keywords

Covid-19Nerve conduction studiesNeuropathyComplication

Outcome Measures

Primary Outcomes (2)

  • Motor nerve function

    The motor nerve study was performed in the median and posterior tibial nerve to assess the motor function of the upper and lower limbs; included Compound motor action potential (CMAP), Motor nerve conduction velocity (MNCV), and nerve conduction latency recording.

    1 MONTH

  • Sensory nerve function

    The sensory nerve study was done for the median and sural nerves including Sensory motor nerve conduction amplitude, latency, and velocity were recorded.

    1 MONTH

Study Arms (2)

Covid-19 Group

Motor nerve study was performed in the median and posterior tibial nerve to assess the motor function of the upper and lower limbs. Sensory nerve study was done for the median and sural nerves to estimate the peripheral neurological function of both upper and lower limbs. F wave study was performed for the upper limb in the median nerve.

Control Group

Motor nerve study was performed in the median and posterior tibial nerve to assess the motor function of the upper and lower limbs. Sensory nerve study was done for the median and sural nerves to estimate the peripheral neurological function of both upper and lower limbs. F wave study was performed for the upper limb in the median nerve.

Eligibility Criteria

Age20 Years - 68 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

20 RT-PCR-confirmed COVID-19 patients with neurological manifestations presented at outpatient clinics of chest and neurology departments were recruited. Twenty healthy age and gender-matched volunteers were enrolled in the study.

You may qualify if:

  • Patients with confirmed RT-PCR COVID-19 infection with mild to moderate severity based on the Egyptian ministry of health (MOH) protocol (version 1.4, November 2020) with neurological symptoms suggestive of peripheral neuropathy

You may not qualify if:

  • patients presenting with neurological manifestations other than peripheral neuropathy, such as stroke, cerebral hemorrhage, encephalitis, or meningitis.
  • Patients with any medical condition or comorbidities that may affect the result of the study as diabetes, arthritis, and carpel tunnel syndrome.
  • Severe COVID-19 patients with a critical condition that needs hospitalization and ventilatory support were also excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospitals

Asyut, 71515, Egypt

Location

Related Publications (3)

  • Mao L, Jin H, Wang M, Hu Y, Chen S, He Q, Chang J, Hong C, Zhou Y, Wang D, Miao X, Li Y, Hu B. Neurologic Manifestations of Hospitalized Patients With Coronavirus Disease 2019 in Wuhan, China. JAMA Neurol. 2020 Jun 1;77(6):683-690. doi: 10.1001/jamaneurol.2020.1127.

    PMID: 32275288BACKGROUND

  • Elshebawy H, Ezzeldin MY, Elzamarany EH. Characteristics of COVID and post COVID polyneuropathies in adults and pediatrics: an Egyptian sample. Egypt J Neurol Psychiatr Neurosurg. 2021;57(1):178. doi: 10.1186/s41983-021-00435-9. Epub 2021 Dec 20.

    PMID: 34955631BACKGROUND

  • Ellul MA, Benjamin L, Singh B, Lant S, Michael BD, Easton A, Kneen R, Defres S, Sejvar J, Solomon T. Neurological associations of COVID-19. Lancet Neurol. 2020 Sep;19(9):767-783. doi: 10.1016/S1474-4422(20)30221-0. Epub 2020 Jul 2.

    PMID: 32622375BACKGROUND

MeSH Terms

Conditions

NeuritisCOVID-19

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Waleed Gamal Elddin Khaleel, Lecturer

    Assiut university, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of chest diseases and tuberculosis

Study Record Dates

First Submitted

February 7, 2023

First Posted

February 9, 2023

Study Start

October 1, 2021

Primary Completion

April 1, 2022

Study Completion

September 1, 2022

Last Updated

February 9, 2023

Record last verified: 2023-02

Locations

EG(1)