Motor NeuropathyNCT05721040
Short-term Evaluation of Motor and Sensory Function in Post-COVID-19 Patients
An observational study of Motor Neuropathy and Sensory Neuropathy, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Neuropathy, Sensory Neuropathy
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 1 Sep 2022
- 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 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Coronavirus disease 19 (COVID-19) can cause neuropsychiatric, psychological and psychosocial impairments. Literature regarding the sensory and motor affection of COVID-19 is still limited.
Public health emergencies as COVID-19 are likely to cause adverse neuropsychiatric impacts. Cognitive impairments after SARS-COV-2 infection were noticed, COVID-19 patients complain of poor concentration, declined memory, and insomnia, as well as anxiety and depression symptoms.
in a study; Neurological manifestations described in 36.4% of 214 patients with confirmed COVID-19. However, the symptoms described [dizziness (not further defined), headache, and impaired consciousness] are commonplace in many severe infections and represent disturbances in neurological function rather than a neurological disease per se. Anosmia and ageusia have received much attention, but are ubiquitous in other common upper respiratory tract infections. While a reported increased risk of cerebrovascular disease.
- Conditions
- Motor Neuropathy, Sensory Neuropathy
- Keywords
- Covid-19, Nerve conduction studies, Neuropathy, Complication
- Medical subject headings
- Neuritis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Oct 2021
- Primary completion1 Apr 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Motor NeuropathyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Gamal Elddin Khaleel, Assiut University
- Investigators
- Waleed Gamal Elddin Khaleel, Lecturer, Principal investigator, Assiut university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721040
- Sponsor's protocol ID
- Covid-19 NCS
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2023
- Last updated
- 9 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32275288Elshebawy 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.
PubMed 34955631Ellul 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.
PubMed 32622375
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Evaluation of Motor and Sensory Function in Post-COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05721040
- Acronym / sponsor ID
- Covid-19 NCS
- Conditions
- Motor Neuropathy, Sensory Neuropathy
- Keywords
- Covid-19, Nerve conduction studies, Neuropathy, Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 9 Feb 2023 (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.
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.
Detailed description
Coronavirus disease 19 (COVID-19) can cause neuropsychiatric, psychological and psychosocial impairments. Literature regarding the sensory and motor affection of COVID-19 is still limited.
Public health emergencies as COVID-19 are likely to cause adverse neuropsychiatric impacts. Cognitive impairments after SARS-COV-2 infection were noticed, COVID-19 patients complain of poor concentration, declined memory, and insomnia, as well as anxiety and depression symptoms.
in a study; Neurological manifestations described in 36.4% of 214 patients with confirmed COVID-19. However, the symptoms described [dizziness (not further defined), headache, and impaired consciousness] are commonplace in many severe infections and represent disturbances in neurological function rather than a neurological disease per se. Anosmia and ageusia have received much attention, but are ubiquitous in other common upper respiratory tract infections. While a reported increased risk of cerebrovascular disease.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Motor nerve function
Time frame: 1 MONTH
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.
Sensory nerve function
Time frame: 1 MONTH
The sensory nerve study was done for the median and sural nerves including Sensory motor nerve conduction amplitude, latency, and velocity were recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Background: PubMed 32275288Mao 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.
- Background: PubMed 34955631Elshebawy 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.
- Background: PubMed 32622375Ellul 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.
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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.
Waleed Gamal Elddin Khaleel, Lecturer principal investigator
Assiut university, Egypt
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 Motor Neuropathy and Sensory Neuropathy, run by Assiut 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 9 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor nerve function (time frame: 1 MONTH). The study lists 2 primary outcomes in all. 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 NCT05721040, which also lists 3 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 9 Feb 2023.