FOG-As-PD: Freezing of Gait and Cognition
Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini (Other)
Overall Status
Completed
CT.gov ID
NCT03477578
Collaborator
(none)
305
1
3
103.1
Study Details
Study Description
Brief Summary
The study was aimed to investigate the role of cognition n in FoG.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Alteration of cortical circuits in PD leads to cognitive dysfunctions associated with the development of FoG.
The study was aimed to investigate the role of cognition in FoG.
Study Design
Study Type:
Observational [Patient Registry]
Actual Enrollment
:
305 participants
Observational Model:
Case-Control
Time Perspective:
Other
Official Title:
Freezing of Gait and Cognition: What Can we Learn From Cognition?
Actual Study Start Date
:
Dec 1, 2017
Actual Primary Completion Date
:
Feb 28, 2018
Actual Study Completion Date
:
Mar 1, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| FoG+ Parkinsonian patients with Freezing of Gait |
Other: freezers
neuropsychological evaluation
Other: non freezers
neuropsychological evaluation
|
| FoG- Parkinsonian patients withou Freezing of Gait |
Other: freezers
neuropsychological evaluation
Other: non freezers
neuropsychological evaluation
|
Outcome Measures
Primary Outcome Measures
- UPDRS [5 years]
Unified Parkinson's DIsease Rating Scale
- MMSE [5 years]
Mini-Mental State Examination
- FAB [5 years]
Frontal Behavioural Assessment
- WCST [5 years]
Wisconsin Card Sorting Test
- TMT A-B [5 years]
Trial Making Test A and B
- Rey Auditory-Verbal Learning Test [5 years]
RAVLT
Secondary Outcome Measures
- 6MWT [5 years]
Six-Minute Walk Test
- TUG [5 years]
Timed Up and Go Test
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
- Diagnosis of idiopathic Parkinson's disease according to Gelb et al.
Exclusion Criteria:
- Any other neurological conditions other than PD
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | "Moriggia-Pelascini" Hospital | Gravedona Ed Uniti | CO | Italy | 22015 |
Sponsors and Collaborators
- Ospedale Generale Di Zona Moriggia-Pelascini
Investigators
- Principal Investigator: Giuseppe Frazzitta, MD, Department of Parkinson's disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital - Via Pelascini, 3, 22015, Gravedona ed Uniti, Como, Italy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ospedale Generale Di Zona Moriggia-Pelascini
ClinicalTrials.gov Identifier:
NCT03477578
Other Study ID Numbers:
- FOG-As-PD
First Posted:
Mar 26, 2018
Last Update Posted:
Jul 11, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: