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

Recruiting

• Conditions: Parkinson Disease

• Registration Number: NCT05752656
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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

Not available

Study Timeline

• Study Start: 2022-01-12
• Status Verified: 2023-02
• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-02-21
• Last Update Submitted: 2023-02-21
• Study First Posted: 2023-03-03
• Last Update Posted: 2023-03-03
• Primary Completion: 2023-12-01
• Study Completion: 2034-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of quality of life	One year	Evaluation of the PDQ-39 scale score at baseline (before surgery) and one year after surgery.

Trial Locations

Locations (1)

Flavia Torlizzi; 🇮🇹 Rome, Italy