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Effect of Computer-based Cognitive Training on Attention and Executive Functions in Patients With Parkinson's Disease

Primary Purpose

Parkinson Disease, Executive Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Computer-based cognitive training
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Parkinson Disease focused on measuring parkinson, executive dysfunction, attention, computer-based cognitive training

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with Parkinson's disease AND
  • Montreal cognitive assesment (MOCA)-score between 22-28
  • Motorically cabable of using an iPad
  • Not receiving antipsychotic medicine
  • No comorbid diseases which might influence the level of executive functioning, for an example ADHD or acquired brain damage

Exclusion Criteria:

  • People without Parkinson's disease
  • Parkinson's patients not included in the above inclusion criteria

Sites / Locations

  • Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Brain+ Evolution

Scientific Brain Training PRO

Control group

Arm Description

Intervention: Training with computer-based programme Brain+ Evolution for 8 weeks, receiving follow-ups every second week. Computer-based cognitive training.

Intervention: Training with computer-based programme Scientific Brain Training PRO for 8 weeks, receiving follow-ups every second week. Computer-based cognitive training.

This Group receives no intervention except for the same amount of follow-ups as the two training Groups. This is done to ensure that an effect of training is not aqtually due to the follow-up's with a professional.

Outcomes

Primary Outcome Measures

SDMT
Symbol digit modalities test, neuropsychological test of processing speed
PDQ-39
Parkinson's disease questionnaire; daily functioning and well-being in Parkinson's disease

Secondary Outcome Measures

HADS
Hospital anxiety and depression screening
Digit span
Digit span Wais-IV; Working memory
Verbal fluency
S-Words, animal-names and A/F-words
Stroop colour/word test
Stroop colour/Word test, respone inhibition
Trail Making A and B
Trail Making A and B, cognitive flexibility

Full Information

First Posted
September 14, 2017
Last Updated
January 25, 2021
Sponsor
Bispebjerg Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03285347
Brief Title
Effect of Computer-based Cognitive Training on Attention and Executive Functions in Patients With Parkinson's Disease
Official Title
The Effect of Computer-based Cognitive Training on Attention and Executive Functions in Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
February 29, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The current study adresses the effect of two different computer-based cognitive trianing programmes on attention and executive functions in patients with Parkinson's disease.
Detailed Description
The current study adresses the effect of two different computer-based cognitive training programmes (Brain+ Evolution and Scientific Brain Training PRO) on attention and executive functions in patients with Parkinson's disease. The patients are assigned to one of three groups. Two training groups with each their programme, and a control Group. The training groups will train at home for 8 weeks with follow-ups every second week. The control group will not train at home, but will also receive a follow-up with computer-based stimuli (computerized Card game) every second week, to minimize the possibility that a possible effect is due to the follow-up's with a professional, and not due to the computer training at home.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Executive Dysfunction
Keywords
parkinson, executive dysfunction, attention, computer-based cognitive training

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two intervention Groups training with each their computer-based cognitive programme, one control Group receiving no intervention except for the same amount of follow-ups as the two intervention Groups.
Masking
Outcomes Assessor
Masking Description
Before and after the intervention period, the patients are tested in a neuropsychological battery to asses their executive functioning. The tester is blinded to the Group allocation of the patients.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brain+ Evolution
Arm Type
Experimental
Arm Description
Intervention: Training with computer-based programme Brain+ Evolution for 8 weeks, receiving follow-ups every second week. Computer-based cognitive training.
Arm Title
Scientific Brain Training PRO
Arm Type
Experimental
Arm Description
Intervention: Training with computer-based programme Scientific Brain Training PRO for 8 weeks, receiving follow-ups every second week. Computer-based cognitive training.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This Group receives no intervention except for the same amount of follow-ups as the two training Groups. This is done to ensure that an effect of training is not aqtually due to the follow-up's with a professional.
Intervention Type
Device
Intervention Name(s)
Computer-based cognitive training
Intervention Description
Computer-based cognitive programmes are computer programmes designed as games with the aim of training patients in certain cognitive domains.
Primary Outcome Measure Information:
Title
SDMT
Description
Symbol digit modalities test, neuropsychological test of processing speed
Time Frame
2 minutes
Title
PDQ-39
Description
Parkinson's disease questionnaire; daily functioning and well-being in Parkinson's disease
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
HADS
Description
Hospital anxiety and depression screening
Time Frame
10 minutes
Title
Digit span
Description
Digit span Wais-IV; Working memory
Time Frame
10 minutes
Title
Verbal fluency
Description
S-Words, animal-names and A/F-words
Time Frame
3 minutes
Title
Stroop colour/word test
Description
Stroop colour/Word test, respone inhibition
Time Frame
3 minutes
Title
Trail Making A and B
Description
Trail Making A and B, cognitive flexibility
Time Frame
5 minutes

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with Parkinson's disease AND Montreal cognitive assesment (MOCA)-score between 22-28 Motorically cabable of using an iPad Not receiving antipsychotic medicine No comorbid diseases which might influence the level of executive functioning, for an example ADHD or acquired brain damage Exclusion Criteria: People without Parkinson's disease Parkinson's patients not included in the above inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annemette Løkkegaard, Ph.d.
Organizational Affiliation
Doctor
Official's Role
Study Director
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
State/Province
Region Hovedstaden
ZIP/Postal Code
2400
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34986487
Citation
Svaerke K, Faerk AK, Riis A, Stiegnitz von Ehrenfels SEM, Mogensen J, Lokkegaard A. Effects of Computer-Based Cognitive Rehabilitation on Attention, Executive Functions, and Quality of Life in Patients with Parkinson's Disease: A Randomized, Controlled, Single-Blinded Pilot Study. Dement Geriatr Cogn Disord. 2021;50(6):519-528. doi: 10.1159/000520591. Epub 2022 Jan 5.
Results Reference
derived

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Effect of Computer-based Cognitive Training on Attention and Executive Functions in Patients With Parkinson's Disease

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