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.
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 : * inclusion visit (during the month preceding the start of the program) * 7 sessions of the program (W0, W2, W4, W6, W8, W10, W112) * a visit at 24 weeks (3 months after the end of the program) * a visit at 48 weeks (9 months after the end of the program) 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
24
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.
CHU de Clermont-Fd
Clermont-Ferrand, France
Proportion of patients completing the 7 sessions of the program
Time frame: at the end of the program at 12 weeks
Proportion of ineligible participants after screening and inclusion
Time frame: at inclusion visit
Number of participants who withdrew until the end of the program (Dropout rates).
Time frame: at the end of the program at 12 weeks
Perceived level of interest with a satisfaction questionnaire (The Satisfaction with Therapy and Therapist Scale-Revised (STTS-R)
Time frame: At the end the program at 12 weeks
Participants' experience of the program (practical organization of the sessions, understanding and expectations, overall acceptability and recommendations) using qualitative questionnaire
Time frame: et the end of the program at 12 weeks
Perceived benefits of the program as reported by the participant at 3 months post treatment using qualitative questionnaire
Time frame: at 24 weeks
Perceived benefits of the program as reported by the participant at 9 months post treatment using qualitative questionnaire
Time frame: at 48 weeks
Perceived benefits of the program as reported by one of the patient's relatives at 3 months post treatment using qualitative questionnaire
Time frame: at 24 weeks
Perceived benefits of the program as reported by one of the patient's relatives at 9 months post treatment using qualitative questionnaire
Time frame: at 48 weeks
Level of achievement of individualized functional goals, assessed using GAS (treated as continuous data transformed by the zscore approach)
Time frame: at 24 weeks
Level of achievement of individualized functional goals, assessed using GAS (treated as continuous data transformed by the zscore approach)
Time frame: at 48 weeks
Functional autonomy with the Penn's Parkinson Autonomy Questionnaire-15 items (PDAQ-15)
Time frame: at inclusion visit
Functional autonomy with the Penn's Parkinson Autonomy Questionnaire-15 items (PDAQ-15)
Time frame: at 24 weeks
Functional autonomy with the Penn's Parkinson Autonomy Questionnaire-15 items (PDAQ-15)
Time frame: at 48 weeks
Global subjective cognitive complaints : Subjective Cognitive Complaints Questionnaire for Parkinson's disease (SCCQ-PD)
Time frame: at inclusion visit
Global subjective cognitive complaints : Subjective Cognitive Complaints Questionnaire for Parkinson's disease (SCCQ-PD)
Time frame: at 24 weeks
Global subjective cognitive complaints : Subjective Cognitive Complaints Questionnaire for Parkinson's disease (SCCQ-PD)
Time frame: at 48 weeks
Quality of life using the Parkinson's Disease Questionnaire (PDQ-39)
Time frame: at inclusion visit
Quality of life using the Parkinson's Disease Questionnaire (PDQ-39)
Time frame: at 24 weeks
Quality of life using the Parkinson's Disease Questionnaire (PDQ-39)
Time frame: at 48 weeks
Self-Esteem using the Rosenberg Self-Esteem Scale
Time frame: at inclusion visit
Self-Esteem using the Rosenberg Self-Esteem Scale
Time frame: at 24 weeks
Self-Esteem using the Rosenberg Self-Esteem Scale
Time frame: at 48 weeks
Depressive symptoms using the Beck Depression Inventory II (BDI-II)
Time frame: at inclusion visit
Depressive symptoms using the Beck Depression Inventory II (BDI-II)
Time frame: at 24 weeks
Depressive symptoms using the Beck Depression Inventory II (BDI-II)
Time frame: at 48 weeks
Global cognitive assessment using the Montreal Cognitive Assessment
Time frame: at inclusion visit
Global cognitive assessment using the Montreal Cognitive Assessment
Time frame: at 48 weeks
Episodic memory using the 16-items Free and Cued Selective Reminding Test
Time frame: at inclusion visit
Episodic memory using the 16-items Free and Cued Selective Reminding Test
Time frame: at 48 weeks
Episodic memory using the Brief Visuospatial Memory Test-R
Time frame: at inclusion visit
Episodic memory using brief Visuospatial Memory Test-R
Time frame: at 48 weeks
Attention using Digit Symbol Modalities test
Time frame: at inclusion visit
Attention using Digit Symbol Modalities test
Time frame: at 48 weeks
Attention using the Digit Span (Forward and Backward)
Time frame: at inclusion visit
Attention using digit Span (Forward and Backward)
Time frame: at 48 weeks
Executive functions using oral Letter-Number Sequencing task
Time frame: at inclusion visit
Executive functions using oral Letter-Number Sequencing task
Time frame: at 48 weeks
Executive functions using stroop Color and Word Test D-KEFS
Time frame: at inclusion visit
Executive functions using stroop Color and Word Test D-KEFS
Time frame: at 48 weeks
Visuo spatial treatment using the Benton Judgment of Line Orientation Test
Time frame: at inclusion visit
Visuo spatial treatment using the Benton Judgment of Line Orientation Test
Time frame: at 48 weeks
Visuo spatial treatment using the clock drawing test
Time frame: at inclusion visit
Visuo spatial treatment using the clock drawing test
Time frame: at 48 weeks
Language using the Boston Naming Test (French short form)
Time frame: at inclusion visit
Language using the Boston Naming Test (French short form)
Time frame: at 48 weeks
Participants' experience of the program (practical organization of the sessions, understanding and expectations, overall acceptability and recommendations) using a qualitative questionnaire
at the end of the first session of the program
Time frame: at week 0
Participants' experience of the program (practical organization of the sessions, understanding and expectations, overall acceptability and recommendations) using a qualitative questionnaire
at the end of the session 2 of the program
Time frame: at 2 weeks
Participants' experience of the program (practical organization of the sessions, understanding and expectations, overall acceptability and recommendations) using a qualitative questionnaire
at the end of the session 3 of the program
Time frame: at 4 weeks
Participants' experience of the program (practical organization of the sessions, understanding and expectations, overall acceptability and recommendations) using a qualitative questionnaire
at the end of the session 4 of the program
Time frame: at 6 weeks
Participants' experience of the program (practical organization of the sessions, understanding and expectations, overall acceptability and recommendations) using a qualitative questionnaire
at the end of the session 5 of the program
Time frame: at 8 weeks
Participants' experience of the program (practical organization of the sessions, understanding and expectations, overall acceptability and recommendations) using a qualitative questionnaire
at the end of the session 6 of the program
Time frame: at 10 weeks
Participants' experience of the program (practical organization of the sessions, understanding and expectations, overall acceptability and recommendations) using a qualitative questionnaire
at the end of the session 7 of the program
Time frame: at 12 weeks
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