NCT01155349

Brief Summary

The purpose of this study is to examine the feasibility and potential effectiveness of a cognitive training program among persons with Parkinson's disease. It is hypothesized that individuals with PD will be able to complete and benefit from the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

December 10, 2012

Status Verified

December 1, 2012

Enrollment Period

2.8 years

First QC Date

June 29, 2010

Last Update Submit

December 7, 2012

Conditions

Parkinson's Disease

Keywords

brain fitnesscognitive trainingcognitive interventionspeed of processing trainingParkinson's disease

Outcome Measures

Primary Outcomes (1)

  • Useful Field of View

    A measure of visual processing speed independent of motor speed.

    3 and 6 months

Secondary Outcomes (2)

  • Depressive Symptoms

    3 and 6 months

  • CSRQ

    3 and 6 months

Study Arms (2)

InSight Brain Fitness

EXPERIMENTAL
Behavioral: InSight

No contact-control

PLACEBO COMPARATOR
Other: No contact-control group

Interventions

InSightBEHAVIORAL

A cognitive intervention designed to enhance speed of visual processing.

InSight Brain Fitness
No contact-control groupOTHER

No contact-control group.

No contact-control

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida

Tampa, Florida, 33620, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jerri D Edwards, Ph.D.

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 29, 2010

First Posted

July 1, 2010

Study Start

July 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

December 10, 2012

Record last verified: 2012-12

Locations

US(1)