Multiple SclerosisNeuroRehEMNCT05270239
Function Magnetic Resonance Imaging to Assess Two Therapeutic Strategies in Multiple Sclerosis (NeuroRehEM).
A study testing N-back Cognitive Training and Virtual Reality Motor and Cognitive Training in people with Multiple Sclerosis, run by Universitat Jaume I at 1 site in Spain.
Trial summary
Multiple sclerosis (MS) is an autoimmune disease that causes cognitive and motor disabilities and contributes to decrease patients life quality. Previous results described that there are some MS patients that showed (at least in some phases of the disease) neuroplasticity processes that are able to compensate some… Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- N-back Cognitive Training and Virtual Reality Motor and Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSpain
- Study dates
- 27 May 2022to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Multiple Sclerosis Diagnosis.
Who cannot join
- Other neurological pathologies comorbidity.
- Magnetic resonance imaging incompatibilities.
- Motor impairment degree that impede the task performance.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universitat Jaume I (ImagoBrain Research Group)
Castellon, Castellón, 12006
About this study
Official title: Neurorehabilitation and Functional Recovery in Multiple Sclerosis: Assessing Two Therapeutic Strategies Using Functional Magnetic Resonance Imaging.
Multiple sclerosis (MS) is an autoimmune disease that causes cognitive and motor disabilities and contributes to decrease patients life quality. Previous results described that there are some MS patients that showed (at least in some phases of the disease) neuroplasticity processes that are able to compensate some cognitive deficits. Moreover, neuroplasticity processes seem to be limited and related to the degree of gray matter atrophy (patients with less atrophy show grater neuroplasticity than those with higher atrophy level). The aims of this project are:
- to study behavioral changes (post-training) induced by two different rehabilitation programs: a)cognitive training focused on exclusively enhancing working memory and b) aerobic + cognitive training aimed to enhance attention, working memory processes and motor capabilities using a virtual reality game.
- to study neuroplasticity changes (post-training functional connectivity changes) induced by these rehabilitation programs
- to observe the role of the atrophy in brain neuroplasticity processes.
Neuropathological status and neuroplasticity processes (studied using neuroimaging tools) as well as cognitive performance using neuropsychological tools will be assessed in a group of MS patients (with different phenotypes) at two different time points: before any training (S1) and after 10 days of training (S2). This project will be financed by the Ministerio de ciencia, innovación y universidades of the Spanish government and also have been approved by the Ethical committee of Universitat Jaume I.
- Conditions
- Multiple Sclerosis
- Being tested
- N-back Cognitive Training, Virtual Reality Motor and Cognitive Training
- Keywords
- Multiple Sclerosis, Magnetic Resonance Imaging, Neuroplasticity, Cognitive Impairment, Virtual Reality
- 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.
N-back Cognitive TrainingBehavioural
N-back task mainly trains working memory and information processing speed. This training lasts 10 days (1 hour per day).
Virtual Reality Motor and Cognitive TrainingBehavioural
Virtual Reality "Ball Task" mainly trains inhibitory control, attention, working memory and motor functions. This training lasts 10 days (30 minutes per day)
| Study group | Role | What they receive |
|---|---|---|
| Working Memory Training in MS patients | Experimental | This group of patients will perform a computerized n-back training, which includes a sequence of 2-back and 3-back blocks. Receives: Behavioral: N-back Cognitive Training |
| Virtual Reality Training in MS patients | Experimental | This group of patients will perform a Virtual Reality "Ball Task" training. This task contains 6 trials of increasing difficulty. Receives: Behavioral: Virtual Reality Motor and Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Correct Responses
Number of correct responses in both tasks (n-back computerized task and balls Virtual Reality task)
Measured: Baseline and 10 training days after.
Change from baseline in Reaction Time
This is a primary outcome of the n-back task, which refers to the amount of time (in milliseconds) that elapse from the moment the correct stimulus appears and the correct response is given.
Measured: Baseline and 10 training days after.
Change from baseline in Omissions
In both tasks will be assessed the number of times that a correct stimulus appear and non-response is given.
Measured: Baseline and 10 training days after.
Change from baseline in Errors
The number of times that a distractor stimulus appears and a response is given.
Measured: Baseline and 10 training days after.
Change from baseline in Functional Connectivity in resting state
This is a brain activity measure during resting state through functional magnetic resonance imaging. This outcome will be assessed in both studies.
fMRI sequence: T2-weighted echoplanar imaging sequence.
Measured: Baseline and 10 training days after.
Change from baseline in Functional Connectivity in task performance
This is a brain activity measure during a task performance through functional magnetic resonance imaging. This outcome will be assessed in Virtual Reality study.
fMRI sequence: T2-weighted echoplanar imaging sequence.
Measured: Baseline and 10 training days after.
Change from baseline in SRT-S: Selective Reminding Test (Storing)
A subtest of the BRB-N (The Brief Repeatable Battery of Neuropsychological Tests for MS) which measures memory storage capacity.
Measured: Baseline and 10 training days after.
Change from baseline in SRT-R: Selective Reminding Test (Retrieval)
This subtest of the BRB-N is a measure of memory retrieval capacity.
Measured: Baseline and 10 training days after.
Change from baseline in SRT-D: Selective Reminding Test (Delayed)
This BRB-N subtest measures the delayed memory.
Measured: Baseline and 10 training days after.
Change from baseline in SPART: Spatial Recall Test
A subtest of the BRB-N that measures spatial memory.
Measured: Baseline and 10 training days after.
Change from baseline in SPART-D: Spatial Recall Test (Delayed)
This BRB-N subtest measures the spatial delayed memory.
Measured: Baseline and 10 training days after.
Change from baseline in SDMT: Symbol Digit Modalities Test
A BRB-N subtest which measures information processing speed.
Measured: Baseline and 10 training days after.
Change from baseline in PASAT: Paced Auditory Serial Addition Task
A BRB-N subtest which measures working memory.
Measured: Baseline and 10 training days after.
Change from baseline in Phonemic Fluency
A language measure that assesses phonemic fluency.
Measured: Baseline and 10 training days after.
Change from baseline in Semantic Fluency
A language measure that assesses semantic fluency.
Measured: Baseline and 10 training days after.
Change from baseline in Digit Span Forward
A subtest of the Wechsler Adult Intelligence Scale (WAIS-III) that is an attention measure.
Measured: Baseline and 10 training days after.
Change from baseline in Digit Span Backward
A WAIS-III subtest that is a working memory measure.
Measured: Baseline and 10 training days after.
Change from baseline in Letters and Numbers
A WAIS-III subtest that measures working memory.
Measured: Baseline and 10 training days after.
Secondary outcomes (5)
Total Intracranial Volume (TIV)
A measure of brain volumetry. MRI sequence: structural T1-weighted MPRAGE sequence.
Measured: Baseline
Brain Parenchymal Fraction (BPF)
MRI sequence: structural T1-weighted MPRAGE sequence.
Measured: Baseline
Lesion Volume in white matter tissue
A brain damage volumetry measure. MRI sequence: structural T1-weighted MPRAGE sequence and T2-FLAIR sequence
Measured: Baseline
Cortical Lesions
Number of brain cortical lesions. MRI Sequence: inversion recovery MRI pulse sequence (DIR).
Measured: Baseline
Cortical Thickness
Brain cortical thickness measure. MRI sequence: structural T1-weighted MPRAGE sequence.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start27 May 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristina Forn, Study director, Universitat Jaume I (Castellón, Spain)Carla Sanchis, Study director, Universitat Jaume I (Castellón, Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270239
- Sponsor's protocol ID
- PID2019-106793RB-I00
- Acronym
- NeuroRehEM
- Status last verified
- Jul 2024
- First submitted
- 31 Jan 2022
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not foreseen due to the ethics committee's privacy policy on the protection of personal data. However, upon request, radiological data could be shared.
Publications
Baltruschat SA, Ventura-Campos N, Cruz-Gomez AJ, Belenguer A, Forn C. Gray matter atrophy is associated with functional connectivity reorganization during the Paced Auditory Serial Addition Test (PASAT) execution in Multiple Sclerosis (MS). J Neuroradiol. 2015 Jun;42(3):141-9. doi: 10.1016/j.neurad.2015.02.006. Epub 2015 Apr 6.
PubMed 25857687Cruz-Gomez AJ, Ventura-Campos N, Belenguer A, Avila C, Forn C. The link between resting-state functional connectivity and cognition in MS patients. Mult Scler. 2014 Mar;20(3):338-48. doi: 10.1177/1352458513495584. Epub 2013 Jul 4.
PubMed 23828871Mitolo M, Venneri A, Wilkinson ID, Sharrack B. Cognitive rehabilitation in multiple sclerosis: A systematic review. J Neurol Sci. 2015 Jul 15;354(1-2):1-9. doi: 10.1016/j.jns.2015.05.004. Epub 2015 May 9.
PubMed 25998261Aguirre N, Cruz-Gomez AJ, Esbri SF, Miro-Padilla A, Bueicheku E, Broseta-Torres R, Avila C, Sanchis-Segura C, Forn C. Enhanced frontoparietal connectivity in multiple sclerosis patients and healthy controls in response to an intensive computerized training focused on working memory. Mult Scler Relat Disord. 2021 Jul;52:102976. doi: 10.1016/j.msard.2021.102976. Epub 2021 Apr 24.
PubMed 33964569Sandroff BM, Wylie GR, Sutton BP, Johnson CL, DeLuca J, Motl RW. Treadmill walking exercise training and brain function in multiple sclerosis: Preliminary evidence setting the stage for a network-based approach to rehabilitation. Mult Scler J Exp Transl Clin. 2018 Feb 21;4(1):2055217318760641. doi: 10.1177/2055217318760641. eCollection 2018 Jan-Mar.
PubMed 29497559Aguirre N, Cruz-Gomez AJ, Miro-Padilla A, Bueicheku E, Broseta Torres R, Avila C, Sanchis-Segura C, Forn C. Repeated Working Memory Training Improves Task Performance and Neural Efficiency in Multiple Sclerosis Patients and Healthy Controls. Mult Scler Int. 2019 Apr 16;2019:2657902. doi: 10.1155/2019/2657902. eCollection 2019.
PubMed 31139470
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurorehabilitation and Functional Recovery in Multiple Sclerosis: Assessing Two Therapeutic Strategies Using Functional Magnetic Resonance Imaging.
- ClinicalTrials.gov ID
- NCT05270239
- Acronym / sponsor ID
- NeuroRehEM / PID2019-106793RB-I00
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Magnetic Resonance Imaging, Neuroplasticity, Cognitive Impairment, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Study start
- 27 May 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 8 Mar 2022 (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.
Multiple sclerosis (MS) is an autoimmune disease that causes cognitive and motor disabilities and contributes to decrease patients life quality. Previous results described that there are some MS patients that showed (at least in some phases of the disease) neuroplasticity processes that are able to compensate some cognitive deficits. Moreover, neuroplasticity processes seem to be limited and related to the degree of gray matter atrophy (patients with less atrophy show grater neuroplasticity than those with higher atrophy level). The aims of this project are:
- to study behavioral changes (post-training) induced by two different rehabilitation programs: a)cognitive training focused on exclusively enhancing working memory and b) aerobic + cognitive training aimed to enhance attention, working memory processes and motor capabilities using a virtual reality game.
- to study neuroplasticity changes (post-training functional connectivity changes) induced by these rehabilitation programs
- to observe the role of the atrophy in brain neuroplasticity processes.
Neuropathological status and neuroplasticity processes (studied using neuroimaging tools) as well as cognitive performance using neuropsychological tools will be assessed in a group of MS patients (with different phenotypes) at two different time points: before any training (S1) and after 10 days of training (S2). This project will be financed by the Ministerio de ciencia, innovación y universidades of the Spanish government and also have been approved by the Ethical committee of Universitat Jaume I.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Working Memory Training in MS patients | Experimental | Behavioral: N-back Cognitive TrainingThis group of patients will perform a computerized n-back training, which includes a sequence of 2-back and 3-back blocks. |
| Virtual Reality Training in MS patients | Experimental | Behavioral: Virtual Reality Motor and Cognitive TrainingThis group of patients will perform a Virtual Reality "Ball Task" training. This task contains 6 trials of increasing difficulty. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Multiple Sclerosis Diagnosis.
Key exclusion criteria (3 listed)
- Other neurological pathologies comorbidity.
- Magnetic resonance imaging incompatibilities.
- Motor impairment degree that impede the task performance.
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 |
|---|---|---|
| N-back Cognitive TrainingN-back task mainly trains working memory and information processing speed. This training lasts 10 days (1 hour per day). | Behavioural | Working Memory Training in MS patients |
| Virtual Reality Motor and Cognitive TrainingVirtual Reality "Ball Task" mainly trains inhibitory control, attention, working memory and motor functions. This training lasts 10 days (30 minutes per day) | Behavioural | Virtual Reality Training in MS patients |
Primary outcome
Change from baseline in Correct Responses
Time frame: Baseline and 10 training days after.
Number of correct responses in both tasks (n-back computerized task and balls Virtual Reality task)
Change from baseline in Reaction Time
Time frame: Baseline and 10 training days after.
This is a primary outcome of the n-back task, which refers to the amount of time (in milliseconds) that elapse from the moment the correct stimulus appears and the correct response is given.
Change from baseline in Omissions
Time frame: Baseline and 10 training days after.
In both tasks will be assessed the number of times that a correct stimulus appear and non-response is given.
Change from baseline in Errors
Time frame: Baseline and 10 training days after.
The number of times that a distractor stimulus appears and a response is given.
Change from baseline in Functional Connectivity in resting state
Time frame: Baseline and 10 training days after.
This is a brain activity measure during resting state through functional magnetic resonance imaging. This outcome will be assessed in both studies. fMRI sequence: T2-weighted echoplanar imaging sequence.
Change from baseline in Functional Connectivity in task performance
Time frame: Baseline and 10 training days after.
This is a brain activity measure during a task performance through functional magnetic resonance imaging. This outcome will be assessed in Virtual Reality study. fMRI sequence: T2-weighted echoplanar imaging sequence.
Change from baseline in SRT-S: Selective Reminding Test (Storing)
Time frame: Baseline and 10 training days after.
A subtest of the BRB-N (The Brief Repeatable Battery of Neuropsychological Tests for MS) which measures memory storage capacity.
Change from baseline in SRT-R: Selective Reminding Test (Retrieval)
Time frame: Baseline and 10 training days after.
This subtest of the BRB-N is a measure of memory retrieval capacity.
Change from baseline in SRT-D: Selective Reminding Test (Delayed)
Time frame: Baseline and 10 training days after.
This BRB-N subtest measures the delayed memory.
Change from baseline in SPART: Spatial Recall Test
Time frame: Baseline and 10 training days after.
A subtest of the BRB-N that measures spatial memory.
Change from baseline in SPART-D: Spatial Recall Test (Delayed)
Time frame: Baseline and 10 training days after.
This BRB-N subtest measures the spatial delayed memory.
Change from baseline in SDMT: Symbol Digit Modalities Test
Time frame: Baseline and 10 training days after.
A BRB-N subtest which measures information processing speed.
Change from baseline in PASAT: Paced Auditory Serial Addition Task
Time frame: Baseline and 10 training days after.
A BRB-N subtest which measures working memory.
Change from baseline in Phonemic Fluency
Time frame: Baseline and 10 training days after.
A language measure that assesses phonemic fluency.
Change from baseline in Semantic Fluency
Time frame: Baseline and 10 training days after.
A language measure that assesses semantic fluency.
Change from baseline in Digit Span Forward
Time frame: Baseline and 10 training days after.
A subtest of the Wechsler Adult Intelligence Scale (WAIS-III) that is an attention measure.
Change from baseline in Digit Span Backward
Time frame: Baseline and 10 training days after.
A WAIS-III subtest that is a working memory measure.
Change from baseline in Letters and Numbers
Time frame: Baseline and 10 training days after.
A WAIS-III subtest that measures working memory.
5 secondary outcomes
Total Intracranial Volume (TIV)
Time frame: Baseline
Brain Parenchymal Fraction (BPF)
Time frame: Baseline
Lesion Volume in white matter tissue
Time frame: Baseline
Cortical Lesions
Time frame: Baseline
Cortical Thickness
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Background: PubMed 25857687Baltruschat SA, Ventura-Campos N, Cruz-Gomez AJ, Belenguer A, Forn C. Gray matter atrophy is associated with functional connectivity reorganization during the Paced Auditory Serial Addition Test (PASAT) execution in Multiple Sclerosis (MS). J Neuroradiol. 2015 Jun;42(3):141-9. doi: 10.1016/j.neurad.2015.02.006. Epub 2015 Apr 6.
- Background: PubMed 23828871Cruz-Gomez AJ, Ventura-Campos N, Belenguer A, Avila C, Forn C. The link between resting-state functional connectivity and cognition in MS patients. Mult Scler. 2014 Mar;20(3):338-48. doi: 10.1177/1352458513495584. Epub 2013 Jul 4.
- Background: PubMed 25998261Mitolo M, Venneri A, Wilkinson ID, Sharrack B. Cognitive rehabilitation in multiple sclerosis: A systematic review. J Neurol Sci. 2015 Jul 15;354(1-2):1-9. doi: 10.1016/j.jns.2015.05.004. Epub 2015 May 9.
- Background: PubMed 33964569Aguirre N, Cruz-Gomez AJ, Esbri SF, Miro-Padilla A, Bueicheku E, Broseta-Torres R, Avila C, Sanchis-Segura C, Forn C. Enhanced frontoparietal connectivity in multiple sclerosis patients and healthy controls in response to an intensive computerized training focused on working memory. Mult Scler Relat Disord. 2021 Jul;52:102976. doi: 10.1016/j.msard.2021.102976. Epub 2021 Apr 24.
- Background: PubMed 29497559Sandroff BM, Wylie GR, Sutton BP, Johnson CL, DeLuca J, Motl RW. Treadmill walking exercise training and brain function in multiple sclerosis: Preliminary evidence setting the stage for a network-based approach to rehabilitation. Mult Scler J Exp Transl Clin. 2018 Feb 21;4(1):2055217318760641. doi: 10.1177/2055217318760641. eCollection 2018 Jan-Mar.
- Background: PubMed 31139470Aguirre N, Cruz-Gomez AJ, Miro-Padilla A, Bueicheku E, Broseta Torres R, Avila C, Sanchis-Segura C, Forn C. Repeated Working Memory Training Improves Task Performance and Neural Efficiency in Multiple Sclerosis Patients and Healthy Controls. Mult Scler Int. 2019 Apr 16;2019:2657902. doi: 10.1155/2019/2657902. eCollection 2019.
- Individual participant dataSharing planned: No. Not foreseen due to the ethics committee's privacy policy on the protection of personal data. However, upon request, radiological data could be shared.
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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. This study is not recruiting at the moment.
Cristina Forn study director
Universitat Jaume I (Castellón, Spain)
Carla Sanchis study director
Universitat Jaume I (Castellón, Spain)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-back Cognitive Training and Virtual Reality Motor and Cognitive Training in people with Multiple Sclerosis, run by Universitat Jaume I at 1 site in Spain.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 26 Jul 2024. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Correct Responses (time frame: Baseline and 10 training days after.). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05270239, which also lists 6 linked publications.
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 26 Jul 2024.