Short- and Long-term Behavioral, Cognitive and Motor Outcomes of Frameless Deep Brain Stimulation in Patients With Parkinson's Disease: a Prospective Observational Study

NCT ID: NCT05752656

Last Updated: 2023-03-03

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

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-12

Study Completion Date

2034-01-01

Brief Summary

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The main objective of the study is to evaluate the improvement in quality of life after deep brain stimulation surgery with frameless technique by comparing the PDQ-39 scale score at baseline (before surgery) and one year after surgery.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Clinical examinations

Clinical examinations and administration of clinical scales

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* diagnosis of idiopathic Parkinson's disease according to Movement Disorder Society (MDS) criteria;
* patients who are candidates for deep brain stimulation intervention, according to the international criteria of the "Core assessment program for surgical interventional therapies in Parkinson's disease" (CAPSIT-PD).

Exclusion Criteria

\- patients unable to give informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Flavia Torlizzi

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Francesco Bove, MD

Role: CONTACT

+390630156433

Facility Contacts

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Flavia Torlizzi

Role: primary

+390630156433

Other Identifiers

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4578

Identifier Type: -

Identifier Source: org_study_id

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