Impact of Individual Cognitive Remediation for Parkinson'... | NCT03622840

Studies
Impact of Individual Cognitive Remediation for Parkinson's Disease

NCT03622840

Sponsor

New York Institute of Technology

Status

Terminated

Last Update Posted

Jun 20, 2019Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Cognitive Impairment
Parkinson Disease

Interventions

Cognitive Remediation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Completed

Expanded Access Info

Start Date

Jul 12, 2018Actual

Primary Completion Date

Oct 30, 2018Actual

Completion Date

Oct 30, 2018Actual

First Submitted Date

Jun 20, 2018

First Submission Date that Met QC Criteria

Aug 7, 2018

First Posted Date

Aug 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2019

Last Update Posted Date

Jun 20, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an interventional clinical trial that will be conducted as a pilot project. Investigators hope to conduct the study to obtain at least 10 study completers.

The plan is to screen 20 Parkinson's Disease (PD) patients attending the Academic Health Care Center (AHCC) at NYIT College of Osteopathic Medicine clinic and enroll the eligible candidates based on the inclusion and exclusion criteria. Subjects will have 11 study visits over the 11-week period. Subjects cognition will be assessed using a paper-based Test of Memory and Learning (TOMAL) tool. The same tool will be used to asses and compare the cognition at baseline, and end study visits. The weekly 30-mins of cognitive remediation exercises will be done using the Brain. HQ cognitive remediation software.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parkinson's disease patients with cognitive impairment	Other	Online cognitive remediation program.	Behavioral: Cognitive Remediation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cognitive Remediation	Behavioral	Weekly 30-45mins Cognitive Remediation Sessions over 11 weeks	Parkinson's disease patients with cognitive impairment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of Test of Memory and Learning (TOMAL) score	Paper based memory and attention test administered at the beginning and end of the study	Baseline and 11 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects must be between 40 and 75 years old (including both ages) at the time of study screening.
Subjects must have a diagnosis of Parkinson's Disease by a physician.
Subjects must demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in this research study.
Subjects must have been clinically stable (non-acute) for 2 weeks prior to consent; in the judgment of the Investigator.
Subjects with a cognition level between Impaired and Average (scaled score between 4-12 or Index Score between 70-110) based on TOMAL Cognitive assessment at Visit 1
Subjects must have the visual, auditory, and motor capacity to use the intervention in the judgment of the Principal Investigator.

Exclusion Criteria:

Subjects who are participating in a concurrent research study or another interventional clinical trial 30 days prior to consenting.
Subjects having a history of mental retardation or pervasive developmental disorder; or other co-morbid neurological disorder (e.g., epilepsy.)
Subjects who appear to be intoxicated or under the influence of a controlled substance on any day of assessment must be rescheduled and may be discontinued based upon the discretion of the investigator
Subjects on medications that affect the cognition in the last 12 hours prior to the study visits that assess the cognitive functions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anu Raj, Psy.D	New York Institute of Technology College of Osteopathic Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York Institute of Technology College of Osteopathic Medicine		Old Westbury	New York	11568	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D020734	Parkinsonian Disorders

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities

ID	Term
D060825	Cognitive Dysfunction
D010300	Parkinson Disease