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Cognitive Training in Parkinson Study (cogtips)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02920632
Recruitment Status : Active, not recruiting
First Posted : September 30, 2016
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Dutch Parkinson Patient Association
Information provided by (Responsible Party):
Chris Vriend, PhD, VU University Medical Center

Brief Summary:
This study evaluates the efficacy of an eight-week online cognitive training program on objective and subjective cognitive functions in Parkinson's disease. Moreover, we intend to map the effect on brain network function, and if cognitive training can prevent the development of PD-MCI/PD-D after one- and two-year follow-up. In this study, two training groups will be compared (N: 70 vs 70). In a part of the participants MRI will be assessed (N: 40 vs. 40). We expect cognitive training to improve cognitive functions, and to improve the efficiency of brain network function. Moreover, we expect that cognitive training can decrease the risk of PD-MCI/PD-D at one- and two-year follow-up.

Condition or disease Intervention/treatment Phase
Parkinson Disease Impaired Cognition Alteration in Cognition Behavioral: Online cognitive training 1 Behavioral: Online cognitive training 2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: COGTIPS (COGnitive Training In Parkinson Study): The Effect of Online Cognitive Training on Cognition and Brain Networks in Parkinson's Disease
Actual Study Start Date : September 15, 2017
Actual Primary Completion Date : July 17, 2019
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Online cognitive training 1 (N=70)
Eight-week, three times a week during 45 minutes cognitive training
Behavioral: Online cognitive training 1
Eight-week online cognitive training program, three times a week for 45 minutes. The training contains several games that are designed to train cognitive functions.

Active Comparator: Online cognitive training 2 (N=70)
Eight-week, three times a week during 45 minutes cognitive activities
Behavioral: Online cognitive training 2
Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.

No Intervention: Healthy control subjects (N=30)
Reference group to compare cognitive training effects to



Primary Outcome Measures :
  1. Efficacy of the online cognitive training on executive function (1) [ Time Frame: Eight weeks (T1) ]
    Improvement in executive function after eight weeks of cognitive training as measured by the Tower of London


Secondary Outcome Measures :
  1. Efficacy of the online cognitive training on subjective cognitive complaints (1) [ Time Frame: Eight weeks (T1) ]
    Improvement on subjective cognitive complaints after eight weeks of cognitive training, measured by the Parkinson's disease Cognitive Functional Rating Scale (PD-CFRS).

  2. Efficacy of the online cognitive training on subjective cognitive complaints (2) [ Time Frame: Eight weeks (T1) ]
    Improvement on subjective cognitive complaints after eight weeks of cognitive training, measured by the Cognitive failures questionnaire (CFQ).

  3. Efficacy of the online cognitive training on executive cognitive functions (2) [ Time Frame: Eight weeks (T1) ]
    Improvement on executive cognitive functions after eight weeks of cognitive training, measured by the Stroop color-word task. The color-word card (card III) will be corrected for color naming speed (measured by card II).

  4. Efficacy of the online cognitive training on executive cognitive functions (3) [ Time Frame: Eight weeks (T1) ]
    Improvement on executive cognitive functions after eight weeks of cognitive training, measured by the Letter fluency task.

  5. Persistence of cognitive training effect on executive functions at six-month follow-up [ Time Frame: Six months (T2) ]
    Persistence of cognitive training effect on executive functions measured by the Tower of London task at six-month follow-up of no cognitive training.

  6. Persistence of cognitive training effect on executive functions at one-year follow-up [ Time Frame: One year (T3) ]
    Persistence of cognitive training effect on executive functions measured by the Tower of London task at one-year follow-up of no cognitive training.

  7. Persistence of cognitive training effect on executive functions at two-year follow-up [ Time Frame: Two years (T4) ]
    Persistence of cognitive training effect on executive functions measured by the Tower of London task at one-year follow-up of no cognitive training.

  8. Risk reduction of PD-MCI/PD-D development at follow-up [ Time Frame: Six months (T2), one year (T3), two years (T4) ]
    The reduction of the risk on developing PD-MCI or PD-D at six months and one year follow-up. Diagnostic criteria for Level II PD-MCI and probable PD-D will be used.

  9. Online cognitive training effect on brain morphology measured by MRI [ Time Frame: Eight weeks (T1) ]
    The effect of online cognitive training on brain morphology using MRI. Structural changes will be assessed after eight weeks of training (T1).

  10. Online cognitive training effect on structural brain connectivity measured by DTI [ Time Frame: Eight weeks (T1) ]
    The effect of online cognitive training on structural brain connectivity using DTI. Structural changes will be assessed after eight weeks of training (T1).

  11. Online cognitive training effect on brain activity measured by resting state fMRI [ Time Frame: Eight weeks (T1) ]
    The effect of online cognitive training on brain activity using resting state fMRI. Regional activity and functional connectivity changes will be assessed after eight weeks of training (T1).

  12. Online cognitive training effect on brain network topology relative to healthy control group [ Time Frame: Eight weeks (T1) ]
    The effect of online cognitive training on brain network topology using resting state fMRI compared with brain network topology of healthy subjects. Healthy subjects will undergo (functional) MRI scanning once.

  13. Difference between Parkinson's disease patients' brain network topology with or without cognitive impairment, and healthy control subjects. [ Time Frame: Pre-intervention (T0) ]
    Participants will be classified to cognitive impairment or no cognitive impairment, and their brain network topology will be compared with healthy subjects.


Other Outcome Measures:
  1. Age [ Time Frame: Pre-intervention (T0) ]
    Demographic characteristic: age at baseline.

  2. Sex [ Time Frame: Pre-intervention (T0) ]
    Demographic characteristic: sex.

  3. Educational level [ Time Frame: Pre-intervention (T0) ]
    Demographic characteristic: educational level.

  4. Disease duration [ Time Frame: Pre-intervention (T0) ]
    Disease characteristic: disease duration.

  5. Disease stage [ Time Frame: Pre-intervention (T0), one year (T3), two years (T4) ]
    Disease characteristic: disease stage (Hoehn and Yahr stage).

  6. Medication use [ Time Frame: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) ]
    Disease characteristic: medication use.

  7. Motor symptoms [ Time Frame: Pre-intervention (T0), one year (T3), two years (T4) ]
    Motor symptoms assessed by the Unified Parkinson's Disease Rating Scale - III

  8. Depressive symptom severity [ Time Frame: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) ]
    Psychiatric symptom severity, depression (Beck Depression Inventory).

  9. Anxiety symptom severity [ Time Frame: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) ]
    Psychiatric symptom severity, including anxiety (Parkinson Anxiety Scale).

  10. Impulse control disorder symptom severity [ Time Frame: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) ]
    Psychiatric symptom severity, including impulse control disorders (QUIP-RS).

  11. Psychotic symptom severity [ Time Frame: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) ]
    Psychiatric symptom severity, including psychotic symptoms (Questionnaire for psychotic events).

  12. Apathy symptom severity [ Time Frame: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) ]
    Psychiatric symptom severity, including apathy (Apathy Scale).

  13. Expectations of the intervention [ Time Frame: Pre-intervention (T0) ]
    Participants' expectation prior the intervention, measured by the credibility/expectancy questionnaire.

  14. Global cognitive functioning (1) [ Time Frame: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) ]
    Global cognitive functioning assessed by the Montreal Cognitive Assessment (MoCA).

  15. Global cognitive functioning (2) [ Time Frame: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) ]
    Global cognitive functioning assessed by the Pentagon copy test, which is predictive of cognitive detoriation.

  16. Specific cognitive functioning: attention/working memory (1) [ Time Frame: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) ]
    Attention function, measured by the Stroop task part I: word naming.

  17. Specific cognitive functioning: attention/working memory (2) [ Time Frame: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) ]
    Working memory function, measured by the backwards digit span test of the Wechsler adult intelligence test (WAIS)-III.

  18. Specific cognitive functioning: episodic memory (1) [ Time Frame: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) ]
    Episodic memory function, measured by the Dutch version of the Auditory verbal learning test (RAVLT).

  19. Specific cognitive functioning: episodic memory (2) [ Time Frame: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) ]
    Episodic memory function, measured by the Location learning task.

  20. Specific cognitive functioning: language (1) [ Time Frame: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) ]
    Language function, measured by the Boston naming task.

  21. Specific cognitive functioning: language (2) [ Time Frame: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) ]
    Language function, measured by the category fluency task.

  22. Specific cognitive functioning: visuospatial/visuoconstructive function (1) [ Time Frame: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) ]
    Visuospatial function, measured by the Benton visual form discrimination task.

  23. Specific cognitive functioning: visuospatial/visuoconstructive function (2) [ Time Frame: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) ]
    Visuospatial function, measured by the Rey complex figure task.

  24. Physical activity [ Time Frame: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4) ]
    Amount of estimated physical activity that a person performes, measured by the New Zealand Physical Activity Questionnaire

  25. Cognitive reserve [ Time Frame: Two years (T4) ]
    Estimation of cognitive reserve measured with the Cognitive Reserve Index questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

--- Parkinson's disease patients ---

Inclusion Criteria:

  • Subjective cognitive complaints, measured by the Parkinson's Disease Cognitive Functional Rating Scale score > 3 (PD-CFRS). A score above 3 indicates significant cognitive complaints, that are milder than complaints associated with Parkinson's disease dementia. This questionnaire is filled in by the patient.
  • Participants' Hoehn & Yahr stage is lower than 4. Patients are stable on dopaminergic medication at least a month before starting the intervention. During the intervention, patient and neurologist will be asked to keep the dopaminergic medication dosage as stable as possible.
  • Participants have access to a computer or tablet, with access to the Internet. If the participant uses a computer, he or she is capable of using a keyboard and computer mouse.
  • Participants are willing to sign informed consent.

Exclusion Criteria:

General criteria:

  • Indications for a dementia syndrome, measured by the Self-administered Gerocognitive Examination score < 14 or the Montreal Cognitive Assessment score < 22.
  • Current drug- or alcohol abuse, measured by a score > 1 on the four CAGE AID-questions (according to the Trimbos guidelines).
  • The inability to undergo extensive neuropsychological assessment, or eight weeks of intervention.
  • Moderate to severe depressive symptoms, as defined by the Beck Depression Inventory score > 18.
  • An impulse control disorder, including internet addiction, screened by the impulse control disorder criteria interview.
  • Psychotic symptoms, screened by the Questionnaire for Psychotic Experiences. Benign hallucinations with insight are not contraindicated.
  • Traumatic brain injury, only in case of a contusio cerebri with 1) loss of consciousness for > 15 minutes and 2) posttraumatic amnesia > 1 hour.
  • A space occupying lesion defined by a radiologist, or significant vascular abnormalities (Fazekas > 1).

For participation in MRI research:

  • Severe claustrophobia
  • Metal in the body (for example, deep brain stimulator or pacemaker)
  • Pregnancy
  • Problems with or shortness of breath during 60 minutes of lying still.

    • Healthy control subjects ---

Inclusion criteria:

- Participants are willing to sign informed consent.

Exclusion criteria:

  • Indications for a neurological disease, such as Parkinson's disease, Alzheimer's disease, mild cognitive impairment, multiple sclerosis or Huntington's disease;
  • Indications for a dementia syndrome, measured by the Montreal Cognitive Assessment score < 22.
  • Indications for a current stroke or CVA, or in the past.
  • Indications for the presence of a psychotic or depressive disorder, measured with a positive screening on the SAPS-PD (benign hallucinations with insight are not contraindicated) and a BDI > 18 respectively.
  • Current drug- or alcohol abuse, measured by a score > 1 on the four CAGE AID-questions (according to the Trimbos guidelines).
  • The inability to undergo extensive neuropsychological assessment, or eight weeks of intervention.
  • Traumatic brain injury, only in case of a contusio cerebri with 1) loss of conciousness for > 15 minutes and 2) posttraumatic amnesia > 1 hour.
  • A space occupying lesion defined by a radiologist, or significant vascular abnormalities (Fazekas > 1).
  • Contra-indications for participation in MRI scanning (see above)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920632


Locations
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Netherlands
VU University Medical Center
Amsterdam, Noord-Holland, Netherlands, 1081HV
Sponsors and Collaborators
VU University Medical Center
Dutch Parkinson Patient Association
Investigators
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Principal Investigator: Chris Vriend, PhD. VU University Medical Center
Principal Investigator: Odile A Van den Heuvel, MD PhD. VU University Medical Center
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chris Vriend, PhD, Principle Investigator, Postdoctoral Researcher, VU University Medical Center
ClinicalTrials.gov Identifier: NCT02920632    
Other Study ID Numbers: CWO/16-10
First Posted: September 30, 2016    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chris Vriend, PhD, VU University Medical Center:
Parkinson
Cognitive training
Cognitive rehabilitation
Brain networks
Additional relevant MeSH terms:
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Parkinson Disease
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders