NCT03285347

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable parkinson-disease

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

First Submitted

Initial submission to the registry

September 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

2.4 years

First QC Date

September 14, 2017

Last Update Submit

January 25, 2021

Conditions

Parkinson DiseaseExecutive Dysfunction

Keywords

parkinsonexecutive dysfunctionattentioncomputer-based cognitive training

Outcome Measures

Primary Outcomes (2)

  • SDMT

    Symbol digit modalities test, neuropsychological test of processing speed

    2 minutes

  • PDQ-39

    Parkinson's disease questionnaire; daily functioning and well-being in Parkinson's disease

    20 minutes

Secondary Outcomes (5)

  • HADS

    10 minutes

  • Digit span

    10 minutes

  • Verbal fluency

    3 minutes

  • Stroop colour/word test

    3 minutes

  • Trail Making A and B

    5 minutes

Study Arms (3)

Brain+ Evolution

EXPERIMENTAL

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

Device: Computer-based cognitive training

Scientific Brain Training PRO

EXPERIMENTAL

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

Device: Computer-based cognitive training

Control group

NO INTERVENTION

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.

Interventions

Computer-based cognitive trainingDEVICE

Computer-based cognitive programmes are computer programmes designed as games with the aim of training patients in certain cognitive domains.

Brain+ EvolutionScientific Brain Training PRO

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • People without Parkinson's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Capital Region, 2400, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 34986487DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Annemette Løkkegaard, Ph.d.

    Doctor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Stud. Psych.

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 18, 2017

Study Start

October 1, 2017

Primary Completion

February 29, 2020

Study Completion

June 30, 2020

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations

DK(1)