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

NCT ID: NCT05807581

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-09

Study Completion Date

2025-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Biomarkers

Group Type NO_INTERVENTION

No interventions assigned to this group

physical activity

Group Type ACTIVE_COMPARATOR

physical activity

Intervention Type OTHER

treadmill running 3 times weekly

sedentary

Group Type NO_INTERVENTION

No interventions assigned to this group

iTBS active

Group Type ACTIVE_COMPARATOR

iTBS

Intervention Type OTHER

repetitive TMS stimulation 5 days weekly for two weeks

iTBS sham

Group Type SHAM_COMPARATOR

iTBS

Intervention Type OTHER

repetitive TMS stimulation 5 days weekly for two weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

physical activity

treadmill running 3 times weekly

Intervention Type OTHER

iTBS

repetitive TMS stimulation 5 days weekly for two weeks

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

IRCCS National Neurological Institute "C. Mondino" Foundation

OTHER

Sponsor Role collaborator

Istituto Neurologico Mediterraneo Neuromed S. R. L

OTHER

Sponsor Role collaborator

Azienda Ospedaliera Universitaria Policlinico "G. Martino"

OTHER

Sponsor Role collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

FLAVIA TORLIZZI

Role: CONTACT

0630155633

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Flavia Torlizzi

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5478

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.