NCT Number: NCT04806568
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
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Thessaloniki, Central Macedonia, 54124, Greece
Location status: Recruiting
Alexandra Anagnostopoulou, MSc
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Antonis Billis, PhD
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Charis Styliadis, PhD
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Ioannis Nikolaidis, PhD
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Nikolaos Grigoriadis, PhD
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Panagiotis D Bamidis, PhD
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Panagiotis Kartsidis, MSc
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Vahe Poghosyan, PhD
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Vasiliki Zilidou, PhD
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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 MS activity. But how accurately and timely can these be captured? The existing clinical tools are subjective and do not have the dynamic of prognosis. It remains uncertain how much change in cognitive status is required to translate into a meaningful clinical outcome and how long it may subsequently take to become apparent. Moving towards a holistic approach, MS-NEUROPLAST aims to further expand previously-published prognostic marker candidates and previous work of the applicant and the members of the research team and employ a group of methodologies for interventions and applications which will quantify via real-world assessment the MS-related cognitive changes in order to characterize not only decline but given the right dosage of stimulation improvement as well.
MS-NEUROPLAST has three main objectives:
(i) Utilize state of-the-art neuroimaging and network science measures to more thoroughly understand neural indices of cognitive impairment in PwMS.
(ii) Evaluate the efficacy for treating MS-associated cognitive deficits using a computerized cognitive training treatment by determining the differences, between subjects treated with cognitive training and controls, on network science measures indexing network efficiency or collapse and on the performance of a battery of neuropsychological tests that are frequently impaired in MS.
(iii) Investigate the dissociation of the cortical mechanisms related to training-induced plasticity and maladaptive reorganization (namely separate good from bad), by taking into account the homeostatic capacity of the human organism as a whole and thus examining whether the correlation of the neurophysiological and cognitive indices with longitudinal digital biomarkers of daily functional status can capture the underlying pathology.
MS-NEUROPLAST stages for PwMS
A. They will undergo a neuropsychological and somatometric assessment
B. Then, they will undergo an electroencephalogram (EEG) measurement which includes the following:
C. Familiarization with using a personal computer or a tablet, and demonstration of both the BrainHQ environment for cognitive training and the wearable and ambient devices.
MS-NEUROPLAST stages for Healthy Controls
A. They will undergo a neuropsychological and somatometric assessment
B. Then, they will undergo an electroencephalogram (EEG) measurement which includes the following:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for people with MS:
Exclusion criteria
for people with MS:
Inclusion criteria
for Healthy Controls:
Exclusion criteria
for Healthy Controls:
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.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
Change of accuracy in the behavioral measurement testing audiovisual integration. Change is defined as statistical significance in the t-test comparison before compared to after the training. A lower score denotes a decline.
Time frame: 3 months
The Mini-Mental State Exam (MMSE) is a test of cognitive function. It includes tests of orientation, attention, memory, language, and visual-spatial skills.
Change is defined as statistical significance in the comparison between before and after the training.
The score ranges from 0 (min) to 100 (max). A lower score denotes a decline.
Time frame: 3 months
The Clock-Drawing Test (CDT) is a simple and effective cognitive test used to assess executive function and visual-spatial function.
Change is defined as statistical significance in the comparison between before and after the training.
The score ranges from 0 (min) to 15 (max). A lower score denotes a decline.
Time frame: 3 months
The Brief Visuospatial Memory Test (BVMT) measures visuospatial memory.
Change is defined as statistical significance in the comparison between before and after the training.
The score ranges from 0 (min) to 36 (max). A lower score denotes a decline.
Time frame: 3 months
The Symbol Digit Modalities Test (SDMT) is a screening instrument to assess cognitive function and especially processing speed.
Change is defined as statistical significance in the comparison between before and after the training.
The score ranges from 0 (min) to 110 (max). Scoring involves summing the number of correct substitutions within the 90-second interval. A lower score denotes a decline.
Time frame: 3 months
Verbal Fluency: Phonemic [ Chi-Sigma-Alpha] is a test of verbal fluency to evaluate the ability to retrieve specific information within restricted search parameters. It can be used as an efficient screening instrument for general verbal functioning.
Change is defined as statistical significance in the comparison between before and after the training.
The score ranges from 0 to as many as many different words as possible generated beginning with each of the following three Greek letters: X (Chi), S (Sigma), and A (Alpha) within 60 seconds. A lower score denotes a decline.
Time frame: 3 months
Verbal Fluency: Semantic [Animals-Fruits-Objects] is a test of verbal fluency to evaluate the ability to retrieve specific information within restricted search parameters.
Change is defined as statistical significance in the comparison between before and after the training.
The score ranges from 0 to as many as many unique words as possible generated within a semantic category (Animals, Fruits, Objects) in 60 seconds. A lower score denotes a decline.
Time frame: 3 months
Digit Span (For-Back-Seq) _WAIS-4GR is a tool to measure one's verbal short-term and working memory.
Change is defined as statistical significance in the comparison between before and after the training.
The score ranges from 0 (min) to 48 (max). A lower score denotes a decline.
Time frame: 3 months
Stroop Neuropsychological Test (SNST) provides a brief screening for brain damage, dysfunction of selective attention, and cognitive flexibility.
Change is defined as statistical significance in the comparison between before and after the training.
The score ranges from 0 (min) to the sum of correct answers within 2 minutes. A lower score denotes a decline.
Time frame: 3 months
The Greek Accentuation Test (GAT) is a test of premorbid intellectual functioning.
Change is defined as statistical significance in the comparison between before and after the training.
The score ranges from 0 (min) to 50 (max). A lower score denotes a decline.
Time frame: 3 months
Depression Anxiety Stress Scale (DASS-21) is a self-report scale designed to measure the negative emotional states of depression, anxiety, and stress.
Change is defined as statistical significance in the comparison between before and after the training.
The score ranges from 0 (min) to 63 (max). A lower score denotes an amelioration or absence of symptoms.
Time frame: 3 months
Multiple sclerosis Impact Scale (MSIS-29) measures coordination, fatigue, flexibility, muscle performance, muscle tone/spasticity, balance/falls, reach and grasp, self-care, health and wellness, leisure, quality of life, role function, social function, and work.
A 29-item, self-report questionnaire designed to measure the physical and psychological impact of MS.
Change is defined as statistical significance in the comparison between before and after the training.
The score ranges from 29 (min) to 116 (max). A lower score denotes an amelioration or absence of symptoms.
Time frame: 3 months
The Cognitive Reserve Questionnaire (CRIq) is an instrument for measuring cognitive reserve.
Change is defined as statistical significance in the comparison between before and after the training.
The questionnaire is divided into 3 sections: CRI-Education, CRI-WorkingActivity, CRI-LeisureTime.
The CRIq score falls into 1 of 5 ordered levels: low (less than 70); medium-low (70-84); medium (85-114); medium-high (115-130); and high (more than 130). A lower score means a lower cognitive reserve.
Time frame: 3 months
The Modified Fatigue Impact Scale (MFIS) is a structured, self-report questionnaire that concerns how fatigue impacts their lives.
Change is defined as statistical significance in the comparison between before and after the training.
The score ranges from 0 (min) to 84 (max). A lower score denotes an amelioration or absence of symptoms.
Time frame: 3 months
The EQ-5D-5L is a self-assessed, health-related, quality-of-life questionnaire. The scale measures the quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Change is defined as statistical significance in the comparison between before and after the training.
A lower score denotes an amelioration or absence of symptoms.
Time frame: 3 months
Change is defined as statistical significance in the comparison between before and after the training.
The score ranges from 0% (min) to 100% (max). The lower the score, the worse the perception of health.
Time frame: 3 months
Beck Depression Inventory-Fast Screen (BDI-FS) is a 21-question self-report inventory for measuring the severity of depression.
Change is defined as statistical significance in the comparison between before and after the training.
The score ranges from 0 (min) to 21 (max). A lower score denotes an amelioration or absence of symptoms.
Time frame: 3 months
The Timed 25-Foot Walk (T25-FW) assesses walking speed and general walking ability on a ~8m (7.62m) corridor.
The T25FW score is calculated by averaging the two tests performed (in seconds).
Time limit per trial: 3 minutes (180 seconds).
Change is defined as statistical significance in the comparison between before and after the training.
An increased measure of timing denotes improvement.
Time frame: 3 months
The 3 m backwards walk test assesses backward walking which is more sensitive to detecting changes in mobility and balance than walking forward.
The score records the time (in seconds) per trial.
Change is defined as statistical significance in the comparison between before and after the training.
An increased measure of timing denotes improvement.
Time frame: 3 months
The Hole Peg Test (9-HPT) is a brief, standardized, quantitative test that assesses upper extremity functionality, looking at how well the patient can use both their primary and non-primary hand to perform a specific task.
Time limit per trial: 5 minutes (300 seconds).
Change is defined as statistical significance in the comparison between before and after the training.
An increased measure of timing denotes improvement.
Time frame: 3 months
The Four Square Step Test (FSST) assesses dynamic stability and the subject's ability to step over low objects forward, sideways, and backward.
The aim is to step as fast as possible into each square with both feet in the following sequence: Square 2, 3, 4, 1, 4, 3, 2, 1 (clockwise to counterclockwise).
The best time (in seconds) of two FSST is the score.
Change is defined as statistical significance in the comparison between before and after the training.
An increased measure of timing denotes improvement.
Time frame: 3 months
The Single Leg Stance Test (SLS): assesses static postural and balance control and is a valuable clinical tool for monitoring neurological and musculoskeletal status as well as for managing fall risk.
It is tested on both legs.
Change is defined as statistical significance in the comparison between before and after the training.
An increased measure of timing denotes improvement.
Time frame: 3 months
The Handgrip Strength Test assesses endurance to the maximum strength of the upper limbs. Grip strength is typically measured in kilograms by squeezing a type of muscle strength testing equipment, known as a dynamometer in each hand.
The average healthy grip strength for men is a squeeze of about 33kg while women typically measure around 20kg.
Change is defined as statistical significance in the comparison between before and after the training.
An increased measure of squeeze denotes improvement.
Contact information is provided by the study sponsor or research team.
Aristotle University Of Thessaloniki
Other
Cognitive Decline Prognosis in Multiple Sclerosis: Effectiveness of a Computerized Cognitive Training Treatment on Cortical Reorganization
Acronym: MSNEUROPLAST
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