MS-NEUROPLAST: Neuroplasticity of Cortical Areas Induced by Cognitive Training in Patients with Multiple Sclerosis
Cognitive Decline Prognosis in Multiple Sclerosis: Effectiveness of a Computerized Cognitive Training Treatment on Cortical Reorganization
Aristotle University Of Thessaloniki
180 participants
Dec 1, 2020
INTERVENTIONAL
Conditions
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 training program
Eligibility
Inclusion Criteria7
- 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
- • Normal hearing and normal or corrected-to-normal vision
Exclusion Criteria12
- 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
- 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
Interventions
The cognitive training treatment is a Greek adaptation of BrainHQ developed by Posit Science Corporation. The intervention will target speed, attention, working memory, and executive function through the visual and auditory domains via a set of 15 exercises. Each daily training session consists of four exercises chosen from an active set of six. Participants will be instructed to train for one hour per day, three days per week, over 12 weeks via a tablet. Each subject will receive at least 29 sessions of computerized cognitive training.
Monitoring of daily activity via Fitbit Charge 4 smartwatch.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04806568