A new single-blind randomized controlled trial testing the efficacy of a telerehabilitation program based on the Rehacom software for cognitive impairment associated with multiple sclerosis (MS) is now open.
The trial will compare the efficacy of specific active rehabilitation to a placebo intervention of the same intensity and lasting the same amount of time.
The multicenter, parallel assignment, open-label trial aims to recruit 150 participants with relapsing-remitting MS (RRMS) at 7 locations across France. Patients are 18 to 55 years of age. Those who have a previous history of other neurological disease or psychiatric comorbidity, including severe depression, those who are currently dependent on alcohol or have other addictions, and those who have acquisition disorders such as dyslexia, dysphasia, dyscalculia, and dyspraxia are not eligible to take part in the study.
Read more about RRMS
Participants will be divided into 2 groups. Those in the first group will receive cognitive rehabilitation consisting of 45 minutes of individual online sessions every week with a speech therapist, while those in the second group will complete daily online exercises 4 days a week for 12 weeks.
The primary outcome measure will be the average change of the 4 reaction time z scores over the 12 weeks of training in the ecological assessment of cognitive impairment using the Urban DailyCog virtual reality task.
Secondary outcome measures will include changes in the neuropsychological test scores, information processing speed, attention and working memory, and patient-reported outcomes, including depression, anxiety, daily cognitive functioning, fatigue, and health-related quality of life.
The trial sponsored by the University Hospital in Bordeaux, France, has yet to be opened for recruitment. Its estimated completion date is November 2024.
Cognitive impairment is the leading cause of disability due to nontraumatic neurological disease in MS. Cognitive rehabilitation is the most promising therapeutic approach for MS-associated cognitive impairment.
Telerehabilitation of multidomain cognitive impairment in multiple sclerosis (TELECOG-MS). US National Library of Medicine. Updated November 9, 2022. Accessed November 21, 2022.