Short- and Long-term Behavioral, Cognitive and Motor Outcomes of Frameless Deep Brain Stimulation in Patients With Parkinson's Disease: a Prospective Observational Study
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT05752656
Collaborator
(none)
100
1
143.6
0.7
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date
:
Jan 12, 2022
Anticipated Primary Completion Date
:
Dec 1, 2023
Anticipated Study Completion Date
:
Jan 1, 2034
Outcome Measures
Primary Outcome Measures
- Improvement of quality of life [One year]
Evaluation of the PDQ-39 scale score at baseline (before surgery) and one year after surgery.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Flavia Torlizzi | Rome | Italy | 00168 |
Sponsors and Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier:
NCT05752656
Other Study ID Numbers:
- 4578
First Posted:
Mar 3, 2023
Last Update Posted:
Mar 3, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: