N/A
N=167
Cognitive Training in Parkinson Study
Parkinson Disease · Impaired Cognition · Alteration in Cognition
Bottom Line
View on ClinicalTrials.gov: NCT02920632 ↗Enrolled (actual)
167
Serious AEs
0.6%
Results posted
Sep 2024
Primary outcome: Primary: Accuracy on the Tower of London Task — 81.2; 82.3; 88.1; 84.0 percentage of correct responses
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Online cognitive training 1 (Behavioral); Online cognitive training 2 (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Amsterdam UMC, location VUmc
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy on the Tower of London Task |
81.2; 82.3; 88.1; 84.0; 84.9 | — |
| SECONDARY Total Score on Parkinson's Disease Cognitive Functional Rating Scale |
8.0; 9.7; 6.9; 8.0 | — |
| SECONDARY Total Score on Cognitive Failures Questionnaire |
38.2; 38.5; 36.9; 38.0 | — |
| SECONDARY Reaction Time on the Tower of London Task |
12.4; 12.7; 11.2; 11.4; 12.1 | — |
| SECONDARY Performance on the Controlled Oral Word Association Test |
38.0; 38.8; 43.7; 42.5; 42.6 | — |
| SECONDARY Performance on Tower of London Accuracy at Six-months Follow-up |
84.3; 84.5 | — |
| SECONDARY Performance on Tower of London Accuracy at One-year Follow-up |
83.3; 84.7 | — |
| SECONDARY Performance on Tower of London Accuracy at Two-year Follow-up |
82.7; 82.1 | — |
| SECONDARY Conversion to Mild Cognitive Impairment or Dementia at One-year Follow-up |
12; 11; 28; 27; 16; 15 | — |
| SECONDARY Performance on the Stroop Color-Word Test, Card I |
54.1; 56.3; 49.2; 50.8; 54.3 | — |
| SECONDARY Performance on the Stroop Color-Word Test, Card III |
114.9; 106.9; 85.9; 101.7; 103.4 | — |
| SECONDARY Conversion of Cognitive Status at Two-year Follow-up |
13; 14; 25; 27; 15; 10 | — |
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.
Eligibility 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 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 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)
Data sourced from ClinicalTrials.gov (NCT02920632). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.