TelerehabilitationNCT06964581
Cognitive Rehabilitation of Deficits in Patients With Multiple Sclerosis
A study testing Cognitive treatment delivered via telerehabilitation. and In-person cognitive treatment. in people with Telerehabilitation and Multiple Sclerosis, run by Universita di Verona at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Telerehabilitation, Multiple Sclerosis, Cognitive Disorders
- What is being tested?
- Cognitive treatment delivered via telerehabilitation. and In-person cognitive treatment.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 8 Feb 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- Presence of other neurological conditions;
- Psychiatric disorders in medical history;
- Alcohol and/or drug abuse;
- Presence of uncorrected severe visual deficits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione
Verona, verona, 37134
Valentina Varalta, Doctor, 045 8124956, valentina.varalta@univr.it
About this study
Official title: Cognitive Rehabilitation of Deficits in Patients With Multiple Sclerosis: Proposal for an Integrated Cognitive Treatment in a Telematic Format
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.
- Being tested
- Cognitive treatment delivered via telerehabilitation., In-person cognitive treatment.
- Keywords
- telerehabilitation, multiple sclerosis, cognitive disorders
- Medical subject headings
- Multiple Sclerosis, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive treatment delivered via telerehabilitation.Behavioural
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.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Experimental | 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. Receives: Behavioral: Cognitive treatment delivered via telerehabilitation. |
| In-person treatment | Active comparator | 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. Receives: Behavioral: In-person cognitive treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paced Auditory Serial Addition Task (PASAT)
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.
Measured: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
Secondary outcomes (10)
Trail Making Test Part A (TMT-A)
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.
Measured: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
Trail Making Test Part B (TMT-B)
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.
Measured: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
Symbol Digit Modalities Test
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).
Measured: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
Modified Five Point Test (MFPT)
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).
Measured: 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)
"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.
Measured: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
Phonemic Verbal Fluency Test
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).
Measured: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
Test of Attentional Performance (TAP)
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).
Measured: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
Modified Fatigue Impact Scale (MFIS)
The Modified Fatigue Impact Scale (MFIS) is used to evaluate the degree of fatigue (range 0-84, with higher scores indicating worse performance).
Measured: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
Multiple Sclerosis Quality of Life 54 (MSQOL-54)
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).
Measured: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
Depression, Anxiety, and Stress Scale (DASS)
The Depression, Anxiety, and Stress Scale (DASS) is used to evaluate psychological well-being (range 0-63, with higher scores indicating worse performance).
Measured: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start8 Feb 2023
- Primary completion22 Apr 2025
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelerehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Varalta, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964581
- Sponsor's protocol ID
- 3995CESC
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation of Deficits in Patients With Multiple Sclerosis: Proposal for an Integrated Cognitive Treatment in a Telematic Format
- ClinicalTrials.gov ID
- NCT06964581
- Acronym / sponsor ID
- 3995CESC
- Keywords
- telerehabilitation, multiple sclerosis, cognitive disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 22 Apr 2025 (actual)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Behavioral: Cognitive treatment delivered via telerehabilitation.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 treatment | Active comparator | Behavioral: In-person cognitive treatment.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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- Presence of other neurological conditions;
- Psychiatric disorders in medical history;
- Alcohol and/or drug abuse;
- Presence of uncorrected severe visual deficits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive treatment delivered via telerehabilitation.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. | Behavioural | Telerehabilitation |
| In-person cognitive treatment.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. | Behavioural | In-person treatment |
Primary outcome
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.
10 secondary outcomes
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
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
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
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
"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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive treatment delivered via telerehabilitation. and In-person cognitive treatment. in people with Telerehabilitation and Multiple Sclerosis, run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valentina Varalta, Doctor (045 8124956, valentina.varalta@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.