Neuropsychological Evaluation for Early Diagnosis of PSP

March 20, 2018 updated by: Ospedale Generale Di Zona Moriggia-Pelascini

The Role of the Neuropsychological Evaluation for Early Diagnosis of Progressive Supranuclear Palsy

The aim of this study is to better understand the nature of the cognitive decline in Progressive Supranuclear Palsy, the time of its development and the relation with the other cardinal features of the disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Progressive Supranuclear Palsy (PSP) is a neurodegenerative disease characterized by vertical supranuclear gaze palsy, early balance dysfunction and falls. Tau-protein aggregation, mainly in the brainstem, is the disease hallmark. Because of the similarities with Parkinson's disease (PD), the diagnosis is made approximately 4 years after the symptoms onset. Cognitive deficits are a leading feature of PSP and they actually represent one of the four functional core domains in the revised diagnostic criteria. The aim of this study is to better understand the nature of this cognitive decline, the time of its development and the relation with the other cardinal features of the disease.

Study Type

Observational

Enrollment (Actual)

112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

56 PSP patients (PSPp) and 56 PD patients (PDp) were enrolled and matched for sex, age and disease duration.

Description

Inclusion Criteria:

  • Patients fulfilling the criteria for idiopathic PD
  • Patients fulfilling the criteria for PSP

Exclusion Criteria:

  • Any other neurodegenerative disorders or medical conditions different from PD / PSP

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PSP patients
Patients suffering from Progressive Supranuclear Palsy (PSP)
Behavioral: Cognitive evaluation
An extensive battery of neuropsychological and motor tests was assessed: MMSE, FAB, MoCA, WCST, Stroop Test, TMT-A and B, Verbal fluency Test, ROCF copy and delayed recall, RAVLT, 6MWT, TUG, BBS.
PD Patients
Patients suffering from Parkinson's disease (PD)
Behavioral: Cognitive evaluation
An extensive battery of neuropsychological and motor tests was assessed: MMSE, FAB, MoCA, WCST, Stroop Test, TMT-A and B, Verbal fluency Test, ROCF copy and delayed recall, RAVLT, 6MWT, TUG, BBS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MMSE
Time Frame: 1 year
Mini-Mental State Examination
1 year
FAB
Time Frame: 1 year
Frontal Assessment Battery
1 year
MoCA
Time Frame: 1 year
Montreal Cognitive Assessment
1 year
WCST
Time Frame: 1 year
Wisconsin Card Sorting Test
1 year
ST
Time Frame: 1 year
Stroop Test
1 year
TMT-A and B
Time Frame: 1 year
Trail Making Test Parts A & B
1 year
VFT
Time Frame: 1 year
Verbal fluency Test
1 year
ROCF copy and delayed recall
Time Frame: 1 year
Rey-Osterrieth complex figure test copy and delayed recall
1 year
RAVLT
Time Frame: 1 year
Rey Auditory Verbal Learning Test
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6MWT
Time Frame: 1 year
6 Minute Walk Test
1 year
TUG
Time Frame: 1 year
Timed Up and Go Test
1 year
BBS
Time Frame: 1 year
Berg Balance Scale
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Generale Di Zona Moriggia-Pelascini

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 2, 2018

Study Registration Dates

First Submitted

March 20, 2018

First Submitted That Met QC Criteria

March 20, 2018

First Posted (Actual)

March 27, 2018

Study Record Updates

Last Update Posted (Actual)

March 27, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPsy-PSP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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