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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05752656
• Other study ID #: 4578
• Status: Recruiting
• Start date: January 12, 2022
• Est. completion date: January 1, 2034

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Francesco Bove, MD
• Phone: +390630156433
• Email: francesco.bove[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2034
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Clinical examinations
Clinical examinations and administration of clinical scales

Locations

Country	Name	City	State
Italy	Flavia Torlizzi	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of quality of life	Evaluation of the PDQ-39 scale score at baseline (before surgery) and one year after surgery.	One year