Parkinson Disease (PD)
Conditions
Keywords
parkinson' s disease, cognitive rehabilitation program, subjective cognitive complaint or a mild cognitive impairment, functional autonomy
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* • Men or women ≥18 years old, diagnosed with idiopathic Parkinson's disease according to the official diagnostic criteria defined by the Movement Disorder Society (MDS) ; * Without cognitive impairment based on neuropsychological evaluation or meeting level 2 Mild Cognitive Impairment (MCI) criteria defined by the MDS, and presenting an early subjective cognitive complaint defined by a score between 1 and 8 on the Subjective Cognitive Complaints Questionnaire for Parkinson's Disease (SCCQ-PD) * Non-demented according to MDS criteria * Ability to understand the protocol; * Ability to provide free and informed consent; * Patients covered by a social insurance system.
Exclusion criteria
* • Any associated neurological disorder or active psychiatric pathology, including severe depressive episode or active psychotic episode. Participants with a Beck Depression Inventory (BDI-II) score above 21 will be excluded from the study and referred to an appropriate healthcare professional for further evaluation and follow-up as needed. * Patients meeting the criteria for Parkinson's disease dementia * Any clinical sign suggesting atypical parkinsonian syndrome (ocular motor disorder, cognitive impairment, apraxia, early falls). * Pregnant or breastfeeding women * Participants under legal protection measures such as judicial protection, deprivation of liberty, curatorship, or guardianship.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients completing the 7 sessions of the program | at the end of the program at 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of ineligible participants after screening and inclusion | at inclusion visit | — |
| Number of participants who withdrew until the end of the program (Dropout rates). | 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) | 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 | 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 | at 24 weeks | — |
| Perceived benefits of the program as reported by the participant at 9 months post treatment using qualitative questionnaire | 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 | 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 | at 48 weeks | — |
| Level of achievement of individualized functional goals, assessed using GAS (treated as continuous data transformed by the zscore approach) | at 24 weeks | — |
| Functional autonomy with the Penn's Parkinson Autonomy Questionnaire-15 items (PDAQ-15) | at inclusion visit | — |
| Global subjective cognitive complaints : Subjective Cognitive Complaints Questionnaire for Parkinson's disease (SCCQ-PD) | at inclusion visit | — |
| Quality of life using the Parkinson's Disease Questionnaire (PDQ-39) | at inclusion visit | — |
| Self-Esteem using the Rosenberg Self-Esteem Scale | at inclusion visit | — |
| Depressive symptoms using the Beck Depression Inventory II (BDI-II) | at inclusion visit | — |
| Global cognitive assessment using the Montreal Cognitive Assessment | at inclusion visit | — |
| Episodic memory using the 16-items Free and Cued Selective Reminding Test | at inclusion visit | — |
| Episodic memory using the Brief Visuospatial Memory Test-R | at inclusion visit | — |
| Episodic memory using brief Visuospatial Memory Test-R | at 48 weeks | — |
| Attention using Digit Symbol Modalities test | at inclusion visit | — |
| Attention using the Digit Span (Forward and Backward) | at inclusion visit | — |
| Attention using digit Span (Forward and Backward) | at 48 weeks | — |
| Executive functions using oral Letter-Number Sequencing task | at inclusion visit | — |
| Executive functions using stroop Color and Word Test D-KEFS | at inclusion visit | — |
| Visuo spatial treatment using the Benton Judgment of Line Orientation Test | at inclusion visit | — |
| Visuo spatial treatment using the clock drawing test | at inclusion visit | — |
| Language using the Boston Naming Test (French short form) | at inclusion visit | — |
| Participants' experience of the program (practical organization of the sessions, understanding and expectations, overall acceptability and recommendations) using a qualitative questionnaire | at week 0 | at the end of the first session of the program |
Countries
France
Contacts
CONTACTLise LACLAUTRE
PRINCIPAL_INVESTIGATORTiphaine VIDAL
University Hospital, Clermont-Ferrand
Outcome results
None listed