Idiopathic Parkinson's Disease: Interest of an Early Group-Based Cognitive Rehabilitation Program (LIFECOG-PD)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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;

Disqualifiers

• 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

Trial design

Design model

Single group

Treatments tested in this trial

  • cognitive rehabilitation program

    Other intervention

    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.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: cognitive rehabilitation programExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients completing the 7 sessions of the program

Time frame
at the end of the program at 12 weeks

Secondary outcomes

1

Proportion of ineligible participants after screening and inclusion

Time frame
at inclusion visit
2

Number of participants who withdrew until the end of the program (Dropout rates).

Time frame
at the end of the program at 12 weeks
3

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
4

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

Other outcomes

Sponsors and contacts

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