Ignite Creation Date:
2024-05-06 @ 6:17 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05611047
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2022-08-30
Brief Title:
Telerehabilitation of Multidomain Cognitive Impairment in Multiple Sclerosis
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Multicentre Randomized Blinded Controlled Study of Specific Telerehabilitation of Multidomain Cognitive Impairment in Multiple Sclerosis Using Mixed Evaluation and Ecological Validity
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TELECOG-MS
Brief Summary:
Treating cognitive impairment CI in multiple sclerosis MS the leading cause of disability due to nontraumatic neurological disease in young adults is an important challenge The contribution of CI to disability in MS has been increasingly recognized and CI has been shown to decrease health-related quality of life HR-QOL even in the early stages of the disease CI negatively impacts daily activities such as driving vocational status absenteeism and instrumental activities in persons living with MS PwMS No medication has proven to have a consistent symptomatic effect on CI in MS and disease-modifying therapies only have a small impact on CI progression
CI in MS is dominated by a slowdown in information processing speed IPS as well as by disturbances of more specific cognitive functions such as attention episodic memory EM working memory WM and executive function EF The alteration of IPS has consequences for WM attention EF and EM IPS impairment predicts subsequent disability and vocational status and changes in quality of life QOL
Cognitive rehabilitation CR is the most promising approach for treating MS-related CI as concluded by recent reviews and meta-analyses despite important methodological shortcomings Methodological limitations in early studies have led to disappointing results and well-designed studies are still scarce As noted recently many studies lack a randomized controlled design that includes passive or active control conditions primary neuropsychological end-points identified a priori evidence of the sustainability of CR and the inclusion of near and far transfer outcomes Tertiary outcomes of QOL metacognition or other patient-reported outcomes PROs are rarely used
In view of the results of these different studies the investigators propose a single-blind randomized controlled trial of a telerehabilitation program for MS associated CI based on Rehacom software using appropriates modules according to specific CI but complemented by individual remote online rehabilitation sessions allowing a better adaptation of the program to the patients deficit a more efficient supervision and meta-cognitive work This program will be evaluated in terms of effectiveness on neuropsychological tests effectiveness on specific cognitive domains re-educated according to the impairments detected in the baseline an ecological evaluation and the impact on daily cognitive functioning Specific active rehabilitation will be compared to a placebo intervention of the same duration and intensity Only a multi-center study will make it possible to achieve sufficient number of patients to meet these objectives
CI in MS is dominated by a slowdown in information processing speed IPS as well as by disturbances of more specific cognitive functions such as attention episodic memory EM working memory WM and executive function EF The alteration of IPS has consequences for WM attention EF and EM IPS impairment predicts subsequent disability and vocational status and changes in quality of life QOL
Cognitive rehabilitation CR is the most promising approach for treating MS-related CI as concluded by recent reviews and meta-analyses despite important methodological shortcomings Methodological limitations in early studies have led to disappointing results and well-designed studies are still scarce As noted recently many studies lack a randomized controlled design that includes passive or active control conditions primary neuropsychological end-points identified a priori evidence of the sustainability of CR and the inclusion of near and far transfer outcomes Tertiary outcomes of QOL metacognition or other patient-reported outcomes PROs are rarely used
In view of the results of these different studies the investigators propose a single-blind randomized controlled trial of a telerehabilitation program for MS associated CI based on Rehacom software using appropriates modules according to specific CI but complemented by individual remote online rehabilitation sessions allowing a better adaptation of the program to the patients deficit a more efficient supervision and meta-cognitive work This program will be evaluated in terms of effectiveness on neuropsychological tests effectiveness on specific cognitive domains re-educated according to the impairments detected in the baseline an ecological evaluation and the impact on daily cognitive functioning Specific active rehabilitation will be compared to a placebo intervention of the same duration and intensity Only a multi-center study will make it possible to achieve sufficient number of patients to meet these objectives
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None