Status:
RECRUITING
MS-NEUROPLAST: Neuroplasticity of Cortical Areas Induced by Cognitive Training in Patients with Multiple Sclerosis
Lead Sponsor:
Aristotle University Of Thessaloniki
Collaborating Sponsors:
King Fahad Medical City
Conditions:
Multiple Sclerosis
Cognitive Decline
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This clinical study aims to identify MS related beneficial plasticity and by contrast maladaptive reorganization in combination with elements of daily functional status as a response to a cognitive tr...
Detailed Description
Cognitive decline is a debilitating and widespread comorbidity of Multiple Sclerosis (MS) affecting up to 65 percent of patients with MS (PwMS). Cognitive changes can be the only behavioral index of M...
Eligibility Criteria
Inclusion
- Inclusion Criteria for people with MS:
- Male/female patients aged 18 to 65 years at screening
- Diagnosis of MS according to the 2017 Revised McDonald criteria
- Disability status at screening with an EDSS score of 0 to 6.5
- Relapsing MS and progressive MS as defined by Lublin
- Neurologically stable within 1 month prior to screening
- Patients receiving the same Disease Modifying Treatment (DMT) for at least 6 months
- Exclusion Criteria for people with MS:
- Patients suspected of not being able or willing to cooperate or comply with study protocol requirements
- Patients meeting criteria for other demyelinating diseases of the CNS
- Patients with active chronic disease (or stable but treated with immune therapy) of the immune system other than MS
- Patients with any other significant CNS disease or serious psychiatric disorder which can interfere with the patient's ability to cooperate or comply with the study procedure
- Patients unable or unwilling to undergo MRI scans and EEG
- Inclusion Criteria for Healthy Controls:
- • Normal hearing and normal or corrected-to-normal vision
- Exclusion Criteria for Healthy Controls:
- Any diagnosed neurological, mental, developmental, or psychiatric disorder
- Unrecovered neurological disorders (i.e., stroke, traumatic brain injury)
- Unstable medication within the last 3 months
- Intake of central nervous drugs (e.g., antidepressants)
- Severe physical disorder
- Concurrent participation in another relevant study
- Patients unable or unwilling to undergo EEG measurements
Exclusion
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04806568
Start Date
December 1 2020
End Date
December 31 2025
Last Update
November 4 2024
Active Locations (1)
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1
Laboratory of Medical Physics and Digital Innovation, AUTH
Thessaloniki, Central Macedonia, Greece, 54124