Function Magnetic Resonance Imaging to Assess Two Therapeutic Strategies in Multiple Sclerosis (NeuroRehEM).

Multiple Sclerosis Clinical Trial

— NeuroRehEM  

Official title:

Neurorehabilitation and Functional Recovery in Multiple Sclerosis: Assessing Two Therapeutic Strategies Using Functional Magnetic Resonance Imaging.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05270239
• Other study ID #: PID2019-106793RB-I00
• Status: Recruiting
• Phase: N/A
• Start date: May 27, 2022
• Est. completion date: May 2023

Study information

• Verified date: November 2022
• Source: Universitat Jaume I
• Contact: Cristina Forn
• Phone: +34 964 38 7658
• Email: forn[@]uji.psb.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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:

1. 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.

2. to study neuroplasticity changes (post-training functional connectivity changes) induced by these rehabilitation programs

3. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

Inclusion Criteria:

• Multiple Sclerosis Diagnosis.

Exclusion Criteria:

• Other neurological pathologies comorbidity.

• Magnetic resonance imaging incompatibilities.

• Motor impairment degree that impede the task performance.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• N-back Cognitive Training
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 Training
Virtual Reality "Ball Task" mainly trains inhibitory control, attention, working memory and motor functions. This training lasts 10 days (30 minutes per day)

Locations

Country	Name	City	State
Spain	Universitat Jaume I (ImagoBrain Research Group)	Castellón De La Plana	Castellón

Sponsors (1)

Lead Sponsor	Collaborator
Universitat Jaume I

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Aguirre N, Cruz-Gómez ÁJ, Esbrí SF, Miró-Padilla A, Bueichekú E, Broseta-Torres R, Ávila 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. — View Citation

Aguirre N, Cruz-Gómez ÁJ, Miró-Padilla A, Bueichekú E, Broseta Torres R, Ávila 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. — View Citation

Baltruschat SA, Ventura-Campos N, Cruz-Gómez ÁJ, 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. — View Citation

Cruz-Gómez ÁJ, Ventura-Campos N, Belenguer A, Ávila 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. — View Citation

Mitolo 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. Review. — View Citation

Sandroff 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Correct Responses	Number of correct responses in both tasks (n-back computerized task and balls Virtual Reality task)	Baseline and 10 training days after.
Primary	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.	Baseline and 10 training days after.
Primary	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.	Baseline and 10 training days after.
Primary	Change from baseline in Errors	The number of times that a distractor stimulus appears and a response is given.	Baseline and 10 training days after.
Primary	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.	Baseline and 10 training days after.
Primary	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.	Baseline and 10 training days after.
Primary	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.	Baseline and 10 training days after.
Primary	Change from baseline in SRT-R: Selective Reminding Test (Retrieval)	This subtest of the BRB-N is a measure of memory retrieval capacity.	Baseline and 10 training days after.
Primary	Change from baseline in SRT-D: Selective Reminding Test (Delayed)	This BRB-N subtest measures the delayed memory.	Baseline and 10 training days after.
Primary	Change from baseline in SPART: Spatial Recall Test	A subtest of the BRB-N that measures spatial memory.	Baseline and 10 training days after.
Primary	Change from baseline in SPART-D: Spatial Recall Test (Delayed)	This BRB-N subtest measures the spatial delayed memory.	Baseline and 10 training days after.
Primary	Change from baseline in SDMT: Symbol Digit Modalities Test	A BRB-N subtest which measures information processing speed.	Baseline and 10 training days after.
Primary	Change from baseline in PASAT: Paced Auditory Serial Addition Task	A BRB-N subtest which measures working memory.	Baseline and 10 training days after.
Primary	Change from baseline in Phonemic Fluency	A language measure that assesses phonemic fluency.	Baseline and 10 training days after.
Primary	Change from baseline in Semantic Fluency	A language measure that assesses semantic fluency.	Baseline and 10 training days after.
Primary	Change from baseline in Digit Span Forward	A subtest of the Wechsler Adult Intelligence Scale (WAIS-III) that is an attention measure.	Baseline and 10 training days after.
Primary	Change from baseline in Digit Span Backward	A WAIS-III subtest that is a working memory measure.	Baseline and 10 training days after.
Primary	Change from baseline in Letters and Numbers	A WAIS-III subtest that measures working memory.	Baseline and 10 training days after.
Secondary	Total Intracraneal Volume (TIV)	A measure of brain volumetry. MRI sequence: structural T1-weighted MPRAGE sequence.	Baseline
Secondary	Brain Parenchimal Fraction (BPF)	MRI sequence: structural T1-weighted MPRAGE sequence.	Baseline
Secondary	Lesion Volume in white matter tissue	A brain damage volumetry measure. MRI sequence: structural T1-weighted MPRAGE sequence and T2-FLAIR sequence	Baseline
Secondary	Cortical Lesions	Number of brain cortical lesions. MRI Sequence: inversion recovery MRI pulse sequence (DIR).	Baseline
Secondary	Cortical Thickness	Brain cortical thickness measure. MRI sequence: structural T1-weighted MPRAGE sequence.	Baseline