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NCT Number: NCT06964581

Cognitive Rehabilitation of Deficits in Patients With Multiple Sclerosis

Non-Inferiority Study, Post-Market Clinical Investigation with a Device, Single-Blind Randomized Controlled Trial in a Cohort of Patients Diagnosed with Multiple Sclerosis (MS).

The aim of the study is to assess whether a computer-based cognitive treatment delivered via telerehabilitation produces effects from T0 to T1 that are not inferior to those of an in-person treatment on sustained attention in a cohort of patients with MS.

The secondary objective is to evaluate the effects of telerehabilitation compared to the same treatment delivered in person on attentional shifting, memory, executive functions, and daily functioning (including cognitive fatigue, quality of life, and mood) in patients with MS.

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Key information

Conditions

Telerehabilitation Autoimmune Diseases Autoimmune Diseases of the Nervous System Cognition Disorders Cognitive Disorders Cognitive Dysfunction Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Mental Disorders Multiple Sclerosis Nervous System Diseases Neurocognitive Disorders Neurorehabilitation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione

Verona, verona, 37134, Italy

Location status: Recruiting

Location contact

Valentina Varalta, Doctor

CONTACT

[email protected]

045 8124956

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of relapsing-remitting multiple sclerosis (RRMS), or primary progressive (PPMS) or secondary progressive (SPMS), defined by at least 3-6 months.
  • Age between 18 and 65 years.
  • Expanded Disability Status Scale (EDSS) between 3 and 5 to include patients with overall neurological disability from mild to moderate.
  • Presence of one or more of the following cognitive disorders (reported by the patient and subsequently confirmed through the Oxford Cognitive Screen-OCS):
  • Memory disorders
  • Attention disorders
  • Executive function disorders
  • Availability of internet at the patient's home necessary for the tele-rehabilitation procedures.
  • Adequate visual and auditory abilities to use the rehabilitation device.

Exclusion criteria

  • Presence of other neurological conditions;
  • Psychiatric disorders in medical history;
  • Alcohol and/or drug abuse;
  • Presence of uncorrected severe visual deficits.

Treatment and study plan

Cognitive treatment delivered via telerehabilitation.

Behavioral

Three hours of cognitive rehabilitation per week, carried out independently and remotely using a computerized device, which is pre-programmed according to the patient's specific needs.

In-person cognitive treatment.

Behavioral

Three hours of in-person cognitive rehabilitation per week using a computerized device. The participant will perform cognitive exercises on the computerized device in the presence of the therapist, who will activate the device (using credentials specifically created for them) and select the appropriate activity to administer at each session.

Primary outcomes

  1. Paced Auditory Serial Addition Task (PASAT)

    Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    In the Paced Auditory Serial Addition Task (PASAT), the patient listens to a recorded voice reading a series of numbers at regular intervals. They must mentally add each number to the one immediately preceding it and respond orally. The test assesses sustained attention, working memory, and processing speed. The maximum score, usually 60, corresponds to the number of correct responses, with higher scores indicating better cognitive performance.

Secondary outcomes

  1. Trail Making Test Part A (TMT-A)

    Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    The Trail Making Test Part A (TMT-A) is a neuropsychological assessment that measures selective attention and processing speed. Participants connect a series of numbered circles in sequential order as quickly as possible. The score is determined by the time taken to complete the task, with shorter times indicating better performance. Errors may negatively impact the score.

  2. Trail Making Test Part B (TMT-B)

    Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    The Trail Making Test Part B (TMT-B) is a neuropsychological test that measures Divided attention. Participants must connect numbered and lettered circles in alternating order as quickly as possible. The score is based on the time taken to complete the test, with shorter times indicating better performance. Any errors may negatively impact the score.

  3. Symbol Digit Modalities Test

    Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    This test evaluates the visual information processing speed and attention; the number of correct answers in 90 seconds is registered (higher scores indicate better performance).

  4. Modified Five Point Test (MFPT)

    Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    The Modified Five Point Test (MFPT), which is a measure of figural fluency assessing the ability to initiate mental productivity and self-monitoring during a visual-spatial task. Performance is assessed by scoring the total number of correct and unique designs generated in 3 min (UDs), and the total number of UDs produced into strategies (CSs).

  5. "Learning" subtest of the Rivermead Behavioural Memory Test-3 (RBMT-3)

    Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    "Learning" subtest of the Rivermead Behavioural Memory Test-3 (RBMT-3), used to assess the ability to learn and recall visuospatial information after a delay. The learning trial has a score range of 0 to 51 correct items, and the delayed recall trial ranges from 0 to 17 correct items, with higher scores indicating better performance.

  6. Phonemic Verbal Fluency Test

    Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    The Phonemic Verbal Fluency Test is used to investigate the ability to access the semantic-lexical store (number of items, with higher scores indicating better performance).

  7. Test of Attentional Performance (TAP)

    Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    The Test of Attentional Performance (TAP) is used to assess reaction times ("Alertness") and the ability to inhibit automatic responses ("Go/No-Go") (reaction times, with higher scores indicating worse performance).

  8. Modified Fatigue Impact Scale (MFIS)

    Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    The Modified Fatigue Impact Scale (MFIS) is used to evaluate the degree of fatigue (range 0-84, with higher scores indicating worse performance).

  9. Multiple Sclerosis Quality of Life 54 (MSQOL-54)

    Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    The Multiple Sclerosis Quality of Life 54 (MSQOL-54) is used to assess quality of life (range varies by item, with higher scores indicating better performance).

  10. Depression, Anxiety, and Stress Scale (DASS)

    Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen

    The Depression, Anxiety, and Stress Scale (DASS) is used to evaluate psychological well-being (range 0-63, with higher scores indicating worse performance).

Study contacts

Contact information is provided by the study sponsor or research team.

Valentina Varalta, Doctor

CONTACT

[email protected]

045 8124956

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Registry information

Official study title

Cognitive Rehabilitation of Deficits in Patients With Multiple Sclerosis: Proposal for an Integrated Cognitive Treatment in a Telematic Format

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 9, 2025
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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