MS-NEUROPLAST: Neuroplasticity of Cortical Areas Induced by Cognitive Training in Patients with Multiple Sclerosis
Recruiting · NCT04806568 · Interventional (participants receive a specific treatment) · Lead sponsor: Aristotle University Of Thessaloniki
View the official record on ClinicalTrials.gov →Interventions studied
Cognitive TrainingMonitoring of daily activity
What this trial is about
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 training program
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Laboratory of Medical Physics and Digital Innovation, AUTH - Thessaloniki, Central Macedonia, Greece