NCT05752656

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
93mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Jan 2022Jan 2034

Study Start

First participant enrolled

January 12, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 3, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
10.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2034

Expected
Last Updated

March 3, 2023

Status Verified

February 1, 2023

Enrollment Period

1.9 years

First QC Date

February 21, 2023

Last Update Submit

February 21, 2023

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Improvement of quality of life

    Evaluation of the PDQ-39 scale score at baseline (before surgery) and one year after surgery.

    One year

Interventions

Clinical examinationsOTHER

Clinical examinations and administration of clinical scales

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients affected by Parkinson's disease and candidates to intervention of deep brain stimulation.

You may qualify if:

  • 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).

You may not qualify if:

  • \- patients unable to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Flavia Torlizzi

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Central Study Contacts

Francesco Bove, MD

CONTACT

+390630156433francesco.bove@policlinicogemelli.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2023

First Posted

March 3, 2023

Study Start

January 12, 2022

Primary Completion

December 1, 2023

Study Completion (Estimated)

January 1, 2034

Last Updated

March 3, 2023

Record last verified: 2023-02

Locations

IT(1)