Cerebrovascular Changes in Multiple Sclerosis Patients

NCT03709290 | Unknown

• 1 other identifier: CVSIMSP
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Multiple sclerosis (MS) MS is a chronic disease containing the inflammatory, demyelinating, anddegenerative processes of the central nervous system. The inflammation, microglial activation, astrocyticgliosis, demyelination, and somewhat axonal loss inwhite matter and grey matter was present in the brainsof the patients with MS . Moreover, MS patientspresented a reduction in the cerebral blood flow (CBF)affecting both grey and white matter in positronemission tomography (PET) studies. MS is the most common autoimmune disorder of the central nervous system. As of 2010, the number of people with MS was 2-2.5 million (approximately 30 per 100,000) globally, with rates varying widely in different regions. MS affects approximately 1000000 people between 17 and 65 years old world wide, the projected prevalence rate of MS for the white US population was 191 per 1000000 and the incidence rate was 7.3 per 1000000 persons . the contribution of neurodegenerative processes in the disease pathogenesis has been increasingly recognized, especially with respect to possible mechanisms of progression. These may include axonal degeneration, mitochondrial injury, energy failure, hypoxia, oxidative damage, iron accumulation or global cerebral hypoperfusion . Interestingly, Cerebral vasomotor reactivity (CVMR) in MS may be impaired as well. Although the cause of CVMR impairment in MS is not clear, several potential factors mightcontribute to this phenomenon. For the purpose of clarity,we divide them into (1) vascular factors, (2) glial factors, and (3)neuronal factors:

1. 1.Vascular factor
2. 2.Glial factors
3. 3.Neuronal factors

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• evaluate cerebrovascular changes in patients with MS byTCD, which is an easy applicable and non-invasivebedside technique

  1 year

Study Arms (2)

1st group

30 patients were diagnosed with MS according to revised MacDonald's criteria 2017 \& collected from Neuropsychiatry department in Assuit university hospital

Radiation: mri

2nd group

30 healthy volunteers subjects matched with age, sex \& education level were recruited from outpatient clinic neuropsychiatry department and included only if they had no current or previous history of any neurological illness and their neurological examination was free

Radiation: mri

Interventions

mri RADIATION

mri brain \& spinal cord

1st group; 2nd group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All patients are subjected to the following: 1. History taking and full general and neurological examination. 2. Laboratory tests: CBC-KFT-LFT-Na-K-PT-PC-INR.. 3. MRI brain and spinal cord: To confirm diagnosis of MS by experienced neuro-radiologist. 4. Visual Evoked potential: Help to confirm diagnosis (detect central demyelination and disseminated in space), VEP was performed using the Nihon Kohden model). MEB-7102 (Nihon Kohden Corp., Tokyo, Japan). 5. Expanded Disability Status Scale (EDSS) \[Kurtzke JF. Et al, 1983\]. This scale provides an overall rating of disabilities based on 0(normal neurological examination) to 10 (death due to MS) point scale, higher scores represent greater degree of disability. 6. Transcranial doppler study

You may qualify if:

• Patients diagnosed with MS or diagnosis of CIS highly suggestive of MS according to revised McDonald's criteria 2010.
• MS patients aged (18-60 years) of both sexes.
• EDSS score (1-7).

You may not qualify if:

• History or current evidence of CNS diseases other than MS which may affect brain volume \&cognition e.g. (Dementia prior to MS, parkinsonism, other inflammatory CNS diseases).
• History or current evidence of medical illness as endocrinal or metabolic which may affect cognitive function e.g. (hepatic, renal impairment or hypothyrodism).
• History or current intake of any drug that may affect cognitive function e.g (Antiepileptic, antipsychotic…).
• History or current evidence of depression (according to DSM -5- criteria \&Hamilton depression scale) or any psychiatric disorder.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 17, 2018
• Study Start: October 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 31, 2021
• Last Updated: July 27, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share