CHU de Clermont-Fd
Clermont-Ferrand, 63000, France
NCT Number: NCT07813156
Current pharmacological treatments have not demonstrated significant improvement in cognitive impairment in Parkinson's disease (PD). Given the high prevalence and serious impact of cognitive impairment in PD, there is a pressing need for non-pharmacological interventions with demonstrated functional benefits. Cognitive rehabilitation is a structured program designed to help improve or compensate for patients' cognitive abilities by providing an approach tailored to each patient's individual needs and goals. Neuropsychologists from French Parkinson's Disease expert centers have developed a new cognitive rehabilitation program called LifeCOG-PD, for PD patients with a subjective cognitive complaint or a mild cognitive impairment (MCI), delivered at the hospital in seven 90-minute sessions conducted in groups of 3-4 participants. This program, combining psychoeducation, practical strategies, and personalized goal setting, aims to maintain patients' daily autonomy, enhance quality of life, and delay the cognitive impact of the disease.
By evaluating feasibility, acceptability and functional outcomes, this study will contribute critical data to inform future PD management guidelines to help support autonomy and cognitive resilience in PD.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Clermont-Ferrand, 63000, France
This pilot interventional therapeutic study will aim at evaluating the feasibility and acceptability of a new cognitive rehabilitation program designed to preserve autonomy and social roles among early PD MCI patients or isolated subjective cognitive complaint.
24 patients will be enrolled in this study in 5 french centers : Clermont-Ferrand, Bordeaux, Créteil, Nancy and Strasbourg.
The inclusion period is 12 months, and each patient's participation duration is a maximum of 13 months. This study will include 10 visits at the hospital :
Patients will receive 7 sessions of 1.5 hours each at their expert centre, spaced 15 days apart, in groups of 3-4 patients. The sessions will address theoretical and practical topics such as working memory and executive functions, attention, and prospective memory in relation to their personal goals. The neuropsychologist will be blinded from the neuropsychological assessment and the functional goals.
If the patient has a caregiver (spouse or other relative), the investigator may propose them to participate in the study. Their participation will consist of completing a satisfaction questionnaire assessing the perceived benefits of the program for the patient at 3 and 9 months post-program. If they agree, the investigator will obtain their agreement to the collection and use of their data within the framework of this research.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive the program in 7 sessions of 1.5 hours each at their expert centre, spaced 15 days apart, in groups of 3-4 patients. The sessions will address theoretical and practical topics such as working memory and executive functions, attention, and prospective memory in relation to their personal goals.
Time frame: at the end of the program at 12 weeks
Time frame: at inclusion visit
Time frame: at the end of the program at 12 weeks
Time frame: At the end the program at 12 weeks
Time frame: et the end of the program at 12 weeks
Time frame: at 24 weeks
Time frame: at 48 weeks
Time frame: at 24 weeks
Time frame: at 48 weeks
Time frame: at 24 weeks
Time frame: at 48 weeks
Time frame: at inclusion visit
Time frame: at 24 weeks
Time frame: at 48 weeks
Time frame: at inclusion visit
Time frame: at 24 weeks
Time frame: at 48 weeks
Time frame: at inclusion visit
Time frame: at 24 weeks
Time frame: at 48 weeks
Time frame: at inclusion visit
Time frame: at 24 weeks
Time frame: at 48 weeks
Time frame: at inclusion visit
Time frame: at 24 weeks
Time frame: at 48 weeks
Time frame: at inclusion visit
Time frame: at 48 weeks
Time frame: at inclusion visit
Time frame: at 48 weeks
Time frame: at inclusion visit
Time frame: at 48 weeks
Time frame: at inclusion visit
Time frame: at 48 weeks
Time frame: at inclusion visit
Time frame: at 48 weeks
Time frame: at inclusion visit
Time frame: at 48 weeks
Time frame: at inclusion visit
Time frame: at 48 weeks
Time frame: at inclusion visit
Time frame: at 48 weeks
Time frame: at inclusion visit
Time frame: at 48 weeks
Time frame: at inclusion visit
Time frame: at 48 weeks
Time frame: at week 0
at the end of the first session of the program
Time frame: at 2 weeks
at the end of the session 2 of the program
Time frame: at 4 weeks
at the end of the session 3 of the program
Time frame: at 6 weeks
at the end of the session 4 of the program
Time frame: at 8 weeks
at the end of the session 5 of the program
Time frame: at 10 weeks
at the end of the session 6 of the program
Time frame: at 12 weeks
at the end of the session 7 of the program
Contact information is provided by the study sponsor or research team.
University Hospital, Clermont-Ferrand
Other
Idiopathic Parkinson's Disease: Interest of an Early Group-Based Cognitive Rehabilitation Program
Acronym: LIFECOG-PD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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