MS-NEUROPLAST: Neuroplasticity of Cortical Areas Induced by Cognitive Training in Patients with Multiple Sclerosis

NCT04806568 | Recruiting

• 1 other identifier: 98223
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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 training program

Conditions

Multiple Sclerosis; Cognitive Decline

Keywords

EEG; Network Efficiency; Adaptive; Plasticity; Maladaptive Reorganization; Cognitive Training

Outcome Measures

Primary Outcomes (3)

• Change in current density strength of the cortical activity as measured via EEG

  Changes in cortical activity strength caused via the training. Change is defined as statistical significance in the t-test comparison of the current density strength as reconstructed via Low Resolution Electromagnetic Tomography (LORETA) algorithm on the basis of high-density EEG recordings, before compared to after the training.

  3 months

• Change in cortical connectivity as measured via EEG

  Changes in cortical connectivity caused via the training. Change is defined as statistical significance in the t-test comparison of Phase Transfer Entropy estimated from the cortical activity, as reconstructed via LORETA algorithm on the basis of high density EEG recordings, before compared to after the training.

  3 months

• Changes in the graph theory indexes as measured via EEG

  Changes in the global and local graph theoretical indices of the brain networks caused via the training. Change is defined as statistical significance in the t-test comparison of the graph theory indices before compared to after the training.

  3 months

Secondary Outcomes (23)

• Change in audiovisual integration functionality

  3 months

• Change in Mini Mental Status Examination (MMSE)

  3 months

• Change in Clock Drawing Test (CDT)

  3 months

• Change in Brief Visuospatial Memory Test (BVMT)

  3 months

• Change in Symbol Digit Modalities Test (SDMT)

  3 months

Study Arms (3)

PwMS-CCT

EXPERIMENTAL

Adult individuals with Multiple Sclerosis will follow a cognitive training intervention. * Neurological assessment * History of Multiple Sclerosis * Expanded Disability Status Scale (EDSS) * 2 types of high-density electroencephalographic recordings * at rest with eyes closed (15 minutes) * event potentials via a multisensory oddball paradigm (45 minutes) * Neuropsychological assessment * MMSE * CDT * GVLT * BVMT * SDMT * Verbal Fluency: Phonemic \[ Chi-Sigma-Alpha\] and Semantic \[Animals-Fruits-Objects\] * Digit Span (For-Back-Seq)\_WAIS-4GR * SNST * GAT * DASS21 * MSIS-29 * CRIq * MFIS * EQ-5D-5L * BDI-II * Somatometric assessment * Timed 25-Foot Walk (T25-FW) * 3m backwards walk test * Hole Peg Test (9-HPT) * Handgrip Strength Test * Single Leg Stance (SLS) * Four Square Step Test (FSST) * BrainHQ training * Monitoring of daily activity

Other: Cognitive Training; Device: Monitoring of daily activity

PwMS-CON

ACTIVE COMPARATOR

Adult individuals with Multiple Sclerosis serving as active controls. * Neurological assessment * History of Multiple Sclerosis * Expanded Disability Status Scale (EDSS) * 2 types of high-density electroencephalographic recordings * at rest with eyes closed (15 minutes) * event potentials via a multisensory oddball paradigm (45 minutes) * Neuropsychological assessment * Mini Mental Status Examination (MMSE) * Clock Drawing Test (CDT) * Greek Verbal Learning Test (GVLT) * Brief Visuospatial Memory Test (BVMT) * Symbol Digit Modalities Test (SDMT) * Verbal Fluency: Phonemic \[ Chi-Sigma-Alpha\] and Semantic \[Animals-Fruits-Objects\] * Digit Span (For-Back-Seq)\_WAIS-4GR * Stroop Neuropsychological Test (SNST) * The Greek Accentuation Test (GAT) * DASS-21 * MSIS-29 * CRIq * MFIS * EQ-5D-5L * BDI-II * Somatometric assessment * T25-FW * 3m backwards walk test * 9-HPT * Handgrip Strength Test * SLS * FSST * Monitoring of dailty activity

Device: Monitoring of daily activity

HC

NO INTERVENTION

Healthy adults serving as passive controls. * 2 types of high-density electroencephalographic recordings * at rest with eyes closed (15 minutes) * event potentials via a multisensory oddball paradigm (45 minutes) * Neuropsychological assessment * Mini Mental Status Examination (MMSE) * Greek Verbal Learning Test (GVLT) * Brief Visuospatial Memory Test (BVMT) * Symbol Digit Modalities Test (SDMT) * Somatometric assessment * Timed 25-Foot Walk (T25-FW) * 3m backwards walk test * Hole Peg Test (9-HPT) * Handgrip Strength Test * Single Leg Stance (SLS) * Four Square Step Test (FSST)

Interventions

Cognitive Training OTHER

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.

PwMS-CCT

Monitoring of daily activity DEVICE

Monitoring of daily activity via Fitbit Charge 4 smartwatch.

PwMS-CCT; PwMS-CON

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Normal hearing and normal or corrected-to-normal vision
• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• King Fahad Medical City: collaborator

Study Sites (1)

Laboratory of Medical Physics and Digital Innovation, AUTH

Thessaloniki, Central Macedonia, 54124, Greece

RECRUITING

Related Publications (2)

• Styliadis C, Kartsidis P, Paraskevopoulos E, Ioannides AA, Bamidis PD. Neuroplastic effects of combined computerized physical and cognitive training in elderly individuals at risk for dementia: an eLORETA controlled study on resting states. Neural Plast. 2015;2015:172192. doi: 10.1155/2015/172192. Epub 2015 Apr 7.

  PMID: 25945260 BACKGROUND

• Klados MA, Styliadis C, Frantzidis CA, Paraskevopoulos E, Bamidis PD. Beta-Band Functional Connectivity is Reorganized in Mild Cognitive Impairment after Combined Computerized Physical and Cognitive Training. Front Neurosci. 2016 Feb 29;10:55. doi: 10.3389/fnins.2016.00055. eCollection 2016.

  PMID: 26973445 BACKGROUND

Related Links

• MS-NEUROPLAST webpage
• MS-NEUROPLAST Facebook page

MeSH Terms

Conditions

Multiple Sclerosis; Cognitive Dysfunction

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Charis Styliadis, PhD

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charis Styliadis, PhD

CONTACT

6942618582; styliadis@hotmail.com

Panagiotis D Bamidis, PhD

CONTACT

bamidis@auth.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients will wear a smartwatch and will be randomly assigned to either the cognitive intervention, or the active control group, stratified by age, sex, education and cognition.

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 19, 2021
• Study Start: December 1, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)