Clinical, Molecular and Electrophysiological Profiling of Parkinson's Disease: the Role of Non-pharmacological Therapies

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Other: iTBS; Other: physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT05807581

5478

Details and patient eligibility

About

In Parkinson's disease (PD), direct evidence linking inflammation to the harmful activities of alpha-synuclein (a-syn) aggregates, the disease onset, and its progression is still lacking. This translational project aims to reveal the causal relationship between a-syn and inflammation. The investigators will also investigate the mechanisms underlying the beneficial effects of two non-pharmacological approaches, motor exercise and neuromodulation, with particular focus on neuroinflammation and brain-derived neurotrophic factor (BDNF) production. the investigators will investigate the molecular pathways and synaptic alterations underlying disease progression. This will be paralleled by a clinical study, in which clinical assessment will be associated with cerebrospinal fluid (CSF) and blood neurodegeneration and inflammatory biomarkers measures. Then, the investigators will test the hypothesis that intensive exercise and neuromodulation may reduce neuroinflammation and a-syn spreading via the activation of BDNF-related pathways.

Enrollment: 400 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinically established diagnosis of PD according to the Movement Disorders Society (MDS) diagnostic criteria
• Hoehn & Yahr (H&Y) stage between 1 and 3

Exclusion criteria

• Pregnancy
• Oncological or autoimmune comorbidities

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 5 patient groups

Biomarkers

No Intervention group

physical activity

Active Comparator group

Treatment:

Other: physical activity

sedentary

No Intervention group

iTBS active

Active Comparator group

Treatment:

Other: iTBS

iTBS sham

Sham Comparator group

Treatment:

Other: iTBS