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Effectiveness of Cognitive Stimulation Treatment in Patients With Parkinson's Disease

I

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Enrolling

Conditions

Parkinson Disease

Treatments

Behavioral: Cognitive training

Study type

Observational

Funder types

Other

Identifiers

NCT06323278
PD&REHAB

Details and patient eligibility

About

The goal of this observational study is to evaluate the relationship between GBA mutation and cognitive stimulation treatment response in patients with Parkinson's disease. The main questions it aim to answer are: • assess whether the GBA mutation is associated with greater or lesser response to cognitive training treatment compared to a control group of PD patients without genetic mutations. • investigate the effect of cognitive stimulation program on behavioural aspects as secondary consequence induced by the possible improvement of cognitive abilities following treatment.

Participants will be undergo to: - a neuropsychological evaluation describing their cognitive profile; - a genetic investigation and finally included in a cognitive stimulation programs according to regular clinical practice. Researchers will compare PD patients with GBA mutation and patients without genetic mutation to evaluate the effectiveness of cognitive stimulation treatment.

Enrollment

68 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with Parkinson's disease according to the Gelb et al. criteria;
  • Patients who have carried out genetic screening for MP;
  • Patients who have a raw score in the range 15.50 to 22.23 at Montreal cognitive assessment (MoCA);
  • Patients who have signed the informed consent and the Privacy Policy;
  • Patients who are included in cognitive stimulation programs according to regular clinical practice.

Exclusion criteria

  • Patients with the initial suspicion of MP that during the diagnostic work-up they were suffering from a different pathology;
  • Patients who have refused consent to participate in the study;
  • Patients with a diagnosis of MP and cognitive profile of dementia;
  • Patients undergoing deep brain neurostimulation (DBS-STN) treatment. Patients treated with DBS-STN were excluded because such treatment involves a surgical procedure whose effects on cognitive functioning could represent an interfering variable.

Trial design

68 participants in 2 patient groups

PD with GBA gene mutation
Description:
Patients with Parkinson's disease and GBA gene mutation treated with cognitive training
Treatment:
Behavioral: Cognitive training
PD without genetic mutation
Description:
Patients with Parkinson's disease without genetic mutation treated with cognitive training
Treatment:
Behavioral: Cognitive training

Trial contacts and locations

1

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Central trial contact

Francesca Mameli, MSc in Psychology; Fabiana Ruggiero, MSc in Psychology

Data sourced from clinicaltrials.gov

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