Cognitive training to improve brain function in multiple sclerosis patients

Cognitive Decline Prognosis in Multiple Sclerosis: Effectiveness of a Computerized Cognitive Training Treatment on Cortical Reorganization

This study is testing if cognitive training can help improve brain function and daily life for people with multiple sclerosis.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Aristotle University Of Thessaloniki (other)
• Locations: 1 site (Thessaloniki, Central Macedonia)
• Trial ID: NCT04806568 on ClinicalTrials.gov

What this trial studies

This clinical study investigates how cognitive training can induce beneficial neuroplasticity in patients with Multiple Sclerosis (MS) while also identifying maladaptive brain changes. It aims to assess cognitive decline, a common issue affecting up to 65% of MS patients, using advanced neuroimaging and network science techniques. The study will compare the effects of cognitive training on brain network efficiency and cognitive performance against a control group. By employing real-world assessments, the research seeks to provide a comprehensive understanding of cognitive changes in MS and their implications for daily functioning.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a confirmed diagnosis of Multiple Sclerosis who are neurologically stable and have a disability status within a specified range.

Not a fit: Patients with other significant CNS diseases or serious psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cognitive function and quality of life for patients with Multiple Sclerosis.

How similar studies have performed: Previous studies have shown promise in using cognitive training to address cognitive deficits in MS, suggesting a potential for success in this approach.

Eligibility criteria

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 this trial is running

Thessaloniki, Central Macedonia

• Laboratory of Medical Physics and Digital Innovation, AUTH — Thessaloniki, Central Macedonia, Greece (RECRUITING)

Study contacts

• Principal investigator: Charis Styliadis, PhD — Aristotle University Of Thessaloniki
• Study coordinator: Charis Styliadis, PhD

Conditions: Multiple Sclerosis, Cognitive Decline, EEG, Network Efficiency, Adaptive, Plasticity, Maladaptive Reorganization, Cognitive Training