Multiple SclerosisNCT05973929
Movement Disorders in Multiple Sclerosis Patients
An observational study of Multiple Sclerosis and Movement Disorders, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of this study is to determine the prevalence of movement disorders in MS patients. Also,To know the clinical type of movement disorders occurring with multiple sclerosis patients and the MRI finding of those patients. Moreover, to find the correlation between the movement disorder and the different types of MS. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Movement Disorders
- What is being tested?
- Screen for movement disorder and correlates it with MRI findings.
- Type of treatment
- Injection or infusion
- How many people
- 57 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Sep 2022to 1 May 2024
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: A randomized cross-sectional study will be conducted on diagnosed multiple sclerosis patients who were diagnosed according to McDonald criteria of MS 2017.
Who may be able to join
- We will study the prevalence of movement disorders in M.S patients, clinical type of movement disorder and the MRI findings. Data collected from patients admitted or following at Al-Azhar university hospitals at Al-Hussein and El-Sayed Galal hospitals. The included eligible patients should fulfil the following inclusion criteria: i. Full clinical history and neurological assessment. ii. Detailed multiple sclerosis history according to MS unit history sheet. iii. Detailed history of movement disorder which include clinical type of movement disorder and medication taken (or not).
- MRI Brain and spine of the included patient will be photographed.
Who cannot join
- 1-Patients with multiple sclerosis mimics which can cause movement disorders e.g., systemic disease or overlap syndromes including systemic lupus, vasculitis, hepatic failure, renal failure, hyperthyroidism, electrolyte disturbances, Behcet's disease or CNS infection.
- 2-patients with primary movement disorders or related to other neurodegenerative diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mostafa Mahmoud Hassan Meshref
Cairo, Select A State Or Province, 11571
Mostafa Meshref, +201557061988, mostafameshref1988@gmail.com
mostafameshref1988@gmail.com
About this study
Official title: Clinical and Radiological Evaluation of Movement Disorders in Multiple Sclerosis Patients.
The aim of this study is to determine the prevalence of movement disorders in MS patients.
Also,To know the clinical type of movement disorders occurring with multiple sclerosis patients and the MRI finding of those patients. Moreover, to find the correlation between the movement disorder and the different types of MS.
Read the detailed description
A randomized cross-sectional study will be conducted on diagnosed multiple sclerosis patients who were diagnosed according to McDonald criteria of MS 2017 (Thompson et al. 2018).
The investigators will study the prevalence of movement disorders in M.S patients, clinical type of movement disorder and the MRI findings. Data collected from patients admitted or following at Al-Azhar university hospitals at Al-Hussein and El-Sayed Galal hospitals. The included eligible patients should fulfil the following inclusion criteria:
- Full clinical history and neurological assessment. ii. Detailed multiple sclerosis history according to MS unit history sheet. iii. Detailed history of movement disorder which include clinical type of movement disorder and medication taken (or not). iv. MRI Brain and spine of the included patient will be photographed.
Exclusion criteria:
- Patients with multiple sclerosis mimics which can cause movement disorders e.g., systemic disease or overlap syndromes including systemic lupus, vasculitis, hepatic failure, renal failure, hyperthyroidism, electrolyte disturbances, Behcet's disease or CNS infection.
- patients with primary movement disorders or related to other neurodegenerative diseases.
- Conditions
- Multiple Sclerosis, Movement Disorders
- Being tested
- Screen for movement disorder and correlates it with MRI findings.
- Keywords
- Multiple sclerosis, Movement Disorders
- Medical subject headings
- Multiple Sclerosis, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screen for movement disorder and correlates it with MRI findings.Other
- To determine the prevalence of movement disorders in MS patients.
- To know the clinical type of movement disorders occurring with multiple sclerosis patients and the MRI finding of those patients.
- To find the correlation between the movement disorder and the different types of MS.
| Study group | Role | What they receive |
|---|---|---|
| Multiple sclerosis patients with movement disorders. | A randomized cross-sectional study will be conducted on diagnosed multiple sclerosis patients who were diagnosed according to McDonald criteria of MS 2017 (Thompson et al. 2018).
We will study the prevalence of movement disorders in M.S patients, clinical type of movement disorder and the MRI findings. Data collected from patients admitted or following at Al-Azhar university hospitals at Al-Hussein and El-Sayed Galal hospitals. The included eligible patients should fulfil the following inclusion criteria:
i. Full clinical history and neurological assessment. ii. Detailed multiple sclerosis history according to MS unit history sheet. iii. Detailed history of movement disorder which include clinical type of movement disorder and medication taken (or not).
iv. MRI Brain and spine of the included patient will be photographed. Receives: Other: Screen for movement disorder and correlates it with MRI findings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the prevalence of movement disorders in MS patients.
To know the percentage of occurance of movement disorders in MS patients.
Measured: Through study completion, an average of 1.5 year
know the clinical type of movement disorders occurring with multiple sclerosis patients and the MRI finding of those patients.
To know the specific semiology for each movement disorder.
Measured: Through study completion, an average of 1.5 year
find the correlation between the movement disorder and the different types of MS.
To know if there is a correlation between the movement disorder and the different types of MS.
Measured: Through study completion, an average of 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start22 Sep 2022
- Primary completion21 Mar 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mahmoud Hassan Meshref, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973929
- Sponsor's protocol ID
- Neuro-Med._0000044
- Status last verified
- Aug 2023
- First submitted
- 26 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abboud H, Yu XX, Knusel K, Fernandez HH, Cohen JA. Movement disorders in early MS and related diseases: A prospective observational study. Neurol Clin Pract. 2019 Feb;9(1):24-31. doi: 10.1212/CPJ.0000000000000560.
PubMed 30859004Calabresi PA. Diagnosis and management of multiple sclerosis. Am Fam Physician. 2004 Nov 15;70(10):1935-44.
PubMed 15571060Cameron MH, Nilsagard Y. Balance, gait, and falls in multiple sclerosis. Handb Clin Neurol. 2018;159:237-250. doi: 10.1016/B978-0-444-63916-5.00015-X.
PubMed 30482317Dendrou CA, Fugger L, Friese MA. Immunopathology of multiple sclerosis. Nat Rev Immunol. 2015 Sep 15;15(9):545-58. doi: 10.1038/nri3871. Epub 2015 Aug 7.
PubMed 26250739Deuschl G. Movement disorders in multiple sclerosis and their treatment. Neurodegener Dis Manag. 2016 Dec;6(6s):31-35. doi: 10.2217/nmt-2016-0053.
PubMed 27874491Fragoso YD, Araujo MG, Branco NL. Kinesigenic paroxysmal hemidyskinesia as the initial presentation of multiple sclerosis. MedGenMed. 2006 Oct 4;8(4):3.
PubMed 17415286Kobelt G, Thompson A, Berg J, Gannedahl M, Eriksson J; MSCOI Study Group; European Multiple Sclerosis Platform. New insights into the burden and costs of multiple sclerosis in Europe. Mult Scler. 2017 Jul;23(8):1123-1136. doi: 10.1177/1352458517694432. Epub 2017 Feb 1.
PubMed 28273775Mehanna R, Jankovic J. Movement disorders in multiple sclerosis and other demyelinating diseases. J Neurol Sci. 2013 May 15;328(1-2):1-8. doi: 10.1016/j.jns.2013.02.007. Epub 2013 Mar 19.
PubMed 23522528Nociti V, Bentivoglio AR, Frisullo G, Fasano A, Soleti F, Iorio R, Loria G, Patanella AK, Marti A, Tartaglione T, Tonali PA, Batocchi AP. Movement disorders in multiple sclerosis: Causal or coincidental association? Mult Scler. 2008 Nov;14(9):1284-7. doi: 10.1177/1352458508094883. Epub 2008 Sep 3.
PubMed 18768580Oakes PK, Srivatsal SR, Davis MY, Samii A. Movement disorders in multiple sclerosis. Phys Med Rehabil Clin N Am. 2013 Nov;24(4):639-51. doi: 10.1016/j.pmr.2013.06.003. Epub 2013 Aug 27.
PubMed 24314682Suarez-Cedeno G, Mehanna R. Movement Disorders in Multiple Sclerosis and Other Demyelinating Diseases: A Retrospective Review From a Tertiary Academic Center. Neurologist. 2021 Sep 7;26(5):161-166. doi: 10.1097/NRL.0000000000000333.
PubMed 34491930Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintore M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21.
PubMed 29275977GBD 2016 Multiple Sclerosis Collaborators. Global, regional, and national burden of multiple sclerosis 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 Mar;18(3):269-285. doi: 10.1016/S1474-4422(18)30443-5. Epub 2019 Jan 21.
PubMed 30679040Waubant E, Alize P, Tourbah A, Agid Y. Paroxysmal dystonia (tonic spasm) in multiple sclerosis. Neurology. 2001 Dec 26;57(12):2320-1. doi: 10.1212/wnl.57.12.2320. No abstract available.
PubMed 11756623
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Evaluation of Movement Disorders in Multiple Sclerosis Patients.
- ClinicalTrials.gov ID
- NCT05973929
- Acronym / sponsor ID
- Neuro-Med._0000044
- Conditions
- Multiple Sclerosis, Movement Disorders
- Keywords
- Multiple sclerosis, Movement Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 21 Mar 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 3 Aug 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.
The aim of this study is to determine the prevalence of movement disorders in MS patients.
Also,To know the clinical type of movement disorders occurring with multiple sclerosis patients and the MRI finding of those patients. Moreover, to find the correlation between the movement disorder and the different types of MS.
Detailed description
A randomized cross-sectional study will be conducted on diagnosed multiple sclerosis patients who were diagnosed according to McDonald criteria of MS 2017 (Thompson et al. 2018).
The investigators will study the prevalence of movement disorders in M.S patients, clinical type of movement disorder and the MRI findings. Data collected from patients admitted or following at Al-Azhar university hospitals at Al-Hussein and El-Sayed Galal hospitals. The included eligible patients should fulfil the following inclusion criteria:
- Full clinical history and neurological assessment. ii. Detailed multiple sclerosis history according to MS unit history sheet. iii. Detailed history of movement disorder which include clinical type of movement disorder and medication taken (or not). iv. MRI Brain and spine of the included patient will be photographed.
Exclusion criteria:
- Patients with multiple sclerosis mimics which can cause movement disorders e.g., systemic disease or overlap syndromes including systemic lupus, vasculitis, hepatic failure, renal failure, hyperthyroidism, electrolyte disturbances, Behcet's disease or CNS infection.
- patients with primary movement disorders or related to other neurodegenerative diseases.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis patients with movement disorders. | – | Other: Screen for movement disorder and correlates it with MRI findings.A randomized cross-sectional study will be conducted on diagnosed multiple sclerosis patients who were diagnosed according to McDonald criteria of MS 2017 (Thompson et al. 2018). We will study the prevalence of movement disorders in M.S patients, clinical type of movement disorder and the MRI findings. Data collected from patients admitted or following at Al-Azhar university hospitals at Al-Hussein and El-Sayed Galal hospitals. The included eligible patients should fulfil the following inclusion criteria: i. Full clinical history and neurological assessment. ii. Detailed multiple sclerosis history according to MS unit history sheet. iii. Detailed history of movement disorder which include clinical type of movement disorder and medication taken (or not). iv. MRI Brain and spine of the included patient will be photographed. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- A randomized cross-sectional study will be conducted on diagnosed multiple sclerosis patients who were diagnosed according to McDonald criteria of MS 2017.
Key inclusion criteria (2 listed)
- We will study the prevalence of movement disorders in M.S patients, clinical type of movement disorder and the MRI findings. Data collected from patients admitted or following at Al-Azhar university hospitals at Al-Hussein and El-Sayed Galal hospitals. The included eligible patients should fulfil the following inclusion criteria: i. Full clinical history and neurological assessment. ii. Detailed multiple sclerosis history according to MS unit history sheet. iii. Detailed history of movement disorder which include clinical type of movement disorder and medication taken (or not).
- MRI Brain and spine of the included patient will be photographed.
Key exclusion criteria (2 listed)
- 1-Patients with multiple sclerosis mimics which can cause movement disorders e.g., systemic disease or overlap syndromes including systemic lupus, vasculitis, hepatic failure, renal failure, hyperthyroidism, electrolyte disturbances, Behcet's disease or CNS infection.
- 2-patients with primary movement disorders or related to other neurodegenerative diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screen for movement disorder and correlates it with MRI findings.* To determine the prevalence of movement disorders in MS patients. * To know the clinical type of movement disorders occurring with multiple sclerosis patients and the MRI finding of those patients. * To find the correlation between the movement disorder and the different types of MS. | Other | Multiple sclerosis patients with movement disorders. |
Primary outcome
Determine the prevalence of movement disorders in MS patients.
Time frame: Through study completion, an average of 1.5 year
To know the percentage of occurance of movement disorders in MS patients.
know the clinical type of movement disorders occurring with multiple sclerosis patients and the MRI finding of those patients.
Time frame: Through study completion, an average of 1.5 year
To know the specific semiology for each movement disorder.
find the correlation between the movement disorder and the different types of MS.
Time frame: Through study completion, an average of 1.5 year
To know if there is a correlation between the movement disorder and the different types of MS.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Results publication: PubMed 30859004Abboud H, Yu XX, Knusel K, Fernandez HH, Cohen JA. Movement disorders in early MS and related diseases: A prospective observational study. Neurol Clin Pract. 2019 Feb;9(1):24-31. doi: 10.1212/CPJ.0000000000000560.
- Results publication: PubMed 15571060Calabresi PA. Diagnosis and management of multiple sclerosis. Am Fam Physician. 2004 Nov 15;70(10):1935-44.
- Results publication: PubMed 30482317Cameron MH, Nilsagard Y. Balance, gait, and falls in multiple sclerosis. Handb Clin Neurol. 2018;159:237-250. doi: 10.1016/B978-0-444-63916-5.00015-X.
- Results publication: PubMed 26250739Dendrou CA, Fugger L, Friese MA. Immunopathology of multiple sclerosis. Nat Rev Immunol. 2015 Sep 15;15(9):545-58. doi: 10.1038/nri3871. Epub 2015 Aug 7.
- Results publication: PubMed 27874491Deuschl G. Movement disorders in multiple sclerosis and their treatment. Neurodegener Dis Manag. 2016 Dec;6(6s):31-35. doi: 10.2217/nmt-2016-0053.
- Results publication: PubMed 17415286Fragoso YD, Araujo MG, Branco NL. Kinesigenic paroxysmal hemidyskinesia as the initial presentation of multiple sclerosis. MedGenMed. 2006 Oct 4;8(4):3.
- Results publication: PubMed 28273775Kobelt G, Thompson A, Berg J, Gannedahl M, Eriksson J; MSCOI Study Group; European Multiple Sclerosis Platform. New insights into the burden and costs of multiple sclerosis in Europe. Mult Scler. 2017 Jul;23(8):1123-1136. doi: 10.1177/1352458517694432. Epub 2017 Feb 1.
- Results publication: PubMed 23522528Mehanna R, Jankovic J. Movement disorders in multiple sclerosis and other demyelinating diseases. J Neurol Sci. 2013 May 15;328(1-2):1-8. doi: 10.1016/j.jns.2013.02.007. Epub 2013 Mar 19.
- Results publication: PubMed 18768580Nociti V, Bentivoglio AR, Frisullo G, Fasano A, Soleti F, Iorio R, Loria G, Patanella AK, Marti A, Tartaglione T, Tonali PA, Batocchi AP. Movement disorders in multiple sclerosis: Causal or coincidental association? Mult Scler. 2008 Nov;14(9):1284-7. doi: 10.1177/1352458508094883. Epub 2008 Sep 3.
- Results publication: PubMed 24314682Oakes PK, Srivatsal SR, Davis MY, Samii A. Movement disorders in multiple sclerosis. Phys Med Rehabil Clin N Am. 2013 Nov;24(4):639-51. doi: 10.1016/j.pmr.2013.06.003. Epub 2013 Aug 27.
- Results publication: PubMed 34491930Suarez-Cedeno G, Mehanna R. Movement Disorders in Multiple Sclerosis and Other Demyelinating Diseases: A Retrospective Review From a Tertiary Academic Center. Neurologist. 2021 Sep 7;26(5):161-166. doi: 10.1097/NRL.0000000000000333.
- Results publication: PubMed 29275977Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintore M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21.
- Individual participant dataSharing planned: Undecided
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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.
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 Multiple Sclerosis and Movement Disorders, run by Al-Azhar 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the prevalence of movement disorders in MS patients. (time frame: Through study completion, an average of 1.5 year). The study lists 3 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 NCT05973929, which also lists 14 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 14 Aug 2023.