Idiopathic Parkinson's DiseaseNCT02525367
Online Cognitive Training in PD, MS and Depressed Patients Treated With Electroconvulsive Therapy
A study testing Online cognitive training in people with Idiopathic Parkinson's Disease and Multiple Sclerosis, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
In Parkinson's disease, Multiple Sclerosis and depressed patients treated with electroconvulsive therapy, cognitive dysfunction is prevalent. However, treatment of these dysfunctions is in its infancy. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Idiopathic Parkinson's Disease, Multiple Sclerosis, Elderly Post Electric Convulsive Therapy
- What is being tested?
- Online cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2016to 7 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General criteria:
- Patients have (access to) a computer with access to the Internet. Patients are capable of using a keyboard and computer mouse.
- Patients are willing to sign informed consent.
- PD-specific criteria:
- A compilation score of executive functions (i.e. Stroop, Trail Making Task, Fluency) shows deficit, which lies between 1 and 2 standard deviation (SD) below the mean of healthy Dutch norm population.
- Patients are diagnosed with Parkinson's disease according to the United Kingdom Parkinson's Disease Society Brain Bank criteria.
Show all 18Show fewer
- Patients are in Hoehn \& Yahr stadium < 4, and are medically stable during a month prior to the intervention. The medication will be attempted to remain stable for the remainder of the intervention.
- Patients are 50 to 70 years old.
- MS-specific criteria:
- A compilation score of episodic memory (i.e. Rey Auditory Verbal Learning Test, Location Learning Test) shows deficit, which lies between 1 and 2 SD below the mean of healthy norm population.
- Patients have been diagnosed with MS for a period longer than three month prior to inclusion in this study according to the renewed McDonald criteria.
- Patients have been on stable medication for at least three months.
- Patients are 30 to 45 years old.
- PostECT-specific criteria:
- Unipolar depressive patients indicated for ECT, who experience cognitive complaints after treatment with ECT.
- Patients have undergone the full ECT-procedure.
- Phonemic fluency and autobiographical memory (measured by the Kopelman Autobiographical Interview) show deficit: significant individual deterioration is present (> 1.5 SD deterioration), accounting for test- retest effects.
- Patients are 50 to 70 years old.
Who cannot join
- General criteria:
- Indications for presence of dementia.
- Presence of traumatic brain injury.
- A psychiatric disorder (in the postECT group: other than unipolar depression).
- No history or presence of drug or alcohol abuse.
- Inability to undergo a neuropsychological assessment (e.g. due to fast fatigue, seeing problems or language barrier).
Show all 12Show fewer
- PD-specific criteria:
- Psychotic symptoms, as screened by the Questionnaire for Psychotic Experiences (QPE). Benign hallucinations with insight are not contraindicated).
- MS-specific criteria:
- Patients with MS can't have relapses or can't use corticosteroids 4 weeks prior to the start of the study.
- postECT-specific criteria:
- Indications for presence of delirium.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
VU University Medical Center
Amsterdam, North Holland, 1118
About this study
Official title: Clinical Pilot Study in the Feasibility and Effect of Online Cognitive Training on Cognitive Functions in Patients With Parkinson's Disease, Multiple Sclerosis and Depressive Patients Treated With Electroconvulsive Therapy
In Parkinson's disease, Multiple Sclerosis and depressed patients treated with electroconvulsive therapy, cognitive dysfunction is prevalent. However, treatment of these dysfunctions is in its infancy.
The purpose of this study is 1) to assess the feasibility of a randomized controlled trial using an online computerized intervention for training cognitive abilities in the three patient groups and 2) to estimate the effect of the online training on objectively and subjectively measured cognitive functions.
The investigators hypothesize that patients using online cognitive training will improve more on cognitive functions, as compared to patients using an active control condition.
Read the detailed description
In neurodegenerative disorders and psychiatric disorders, cognitive dysfunction is frequently reported. In Parkinson's disease (PD), Multiple Sclerosis (MS) and patients treated with electroconvulsive therapy after a severe or therapy resistant depression (postECT), executive dysfunction, attention deficit or episodic/autobiographic memory deficit is prevalent. In MS and PD, these dysfunctions can appear already early in the disease. The majority of PD patients - lifetime prevalence is about 80% - develops PD dementia. In MS, about half of the patients experiences problems with cognitive functions. ECT is used to treat patients with severe and/or therapy resistant depression. However, 30-50% of these patients develops severe cognitive dysfunction. Recovery usually occurs within six months after ECT. However, performances remain below-average compared to norm groups and there are large individual differences. The cognitive difficulties in MS and PD have a significant negative influence on the quality of life. Cognitive dysfunction in PD is associated with decreased independent daily functioning, hospitalization and the development and severity of neuropsychiatric symptoms. Furthermore, in the clinic cognitive dysfunction has been reported to be one of the most dreadful side effects of ECT. However, effective treatment of the described cognitive dysfunction is still in its infancy.
Cognitive training is based upon the principle that plasticity of the brain can facilitate function improvement by intensive training. In several neurological diseases, cognitive training has shown significant improvement in cognitive functions. In MS and PD, earlier studies have been small, frequently without an adequately controlled design. Additionally, earlier cognitive training programs have frequently been executed in a health care organization, impairing patients to successfully attend all training sessions due to mobility impairments. Also, there are limited studies in the effects of cognitive training on improved functioning of daily living and neuropsychiatric symptoms like anxiety and depression. Given the fact that there is an absence in cognitive training studies in patients post-ECT, there is no knowledge about the ability of cognitive training to speed up the natural course.
Using this pilot study, the investigators aim to study the feasibility of a randomized controlled trial using an online computerized intervention for training cognitive abilities in three patient groups. By using a double-blinded, controlled study design, the investigators keep in mind limitations of earlier comparable studies. If this treatment proves to be feasible, and a rough estimated effect size is positive, a larger randomized controlled trial can be executed to study the effectivity of this treatment. When effects are positive, an online cognitive training programme could prove to be a cost-efficient intervention that is accessible at home - something which is important for patients with mobility problems. The investigators hypothesize that patients using online cognitive training will improve more on cognitive functions, as compared to patients using an active training condition.
- Conditions
- Idiopathic Parkinson's Disease, Multiple Sclerosis, Elderly Post Electric Convulsive Therapy
- Being tested
- Online cognitive training, Active control condition
- Keywords
- Parkinson's disease, Multiple Sclerosis, Depressed Elderly, Cognitive Dysfunction, Online Cognitive Training
- Medical subject headings
- Parkinson Disease, Multiple Sclerosis, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online cognitive trainingBehavioural
Also called BrainGymmer, Dezzel Media B.V., The Netherlands
The intervention is a computerized, online training programme which aims to train several cognitive abilities; especially the executive functions, attention, working memory and processing speed. The mental processes that are appealed to by the intervention are similar to processes that are trained in classic face-to-face training methods. Both the intervention protocol and the active control condition will contain several games that have the participant train cognitive functions/perform cognitive activities for 8 weeks, 3 times a week, 45-60 minutes each session.
Active control conditionBehavioural
The active control condition consists of cognitive activities that do not intend to train cognitive functions based on 'cristallized intelligence', such as trivia. Both the intervention protocol and the active control condition will contain several games that have the participant train cognitive functions/perform cognitive activities for 8 weeks, 3 times a week, 45-60 minutes each session.
| Study group | Role | What they receive |
|---|---|---|
| PD-Experimental | Experimental | PD patients using the online cognitive training for 8 weeks, 3 times a week Receives: Behavioral: Online cognitive training |
| PD-Control | Active comparator | PD patients using the active control condition for 8 weeks, 3 times a week Receives: Behavioral: Active control condition |
| MS-Experimental | Experimental | MS patients using the online cognitive training for 8 weeks, 3 times a week Receives: Behavioral: Online cognitive training |
| MS-Control | Active comparator | MS patients using the active control condition for 8 weeks, 3 times a week Receives: Behavioral: Active control condition |
| postECT-Experimental | Experimental | Depressed elderly treated with ECT patients using the online cognitive training for 8 weeks, 3 times a week Receives: Behavioral: Online cognitive training |
| postECT-Control | Active comparator | Depressed elderly treated with ECT patients using the active control condition for 8 weeks, 3 times a week Receives: Behavioral: Active control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
The feasibility of the intervention as reported by the patients on 4-point Likert scale items (T1)
Measured: 8 weeks
Secondary outcomes (7)
Trail Making Task
Cognitive functioning as assessed by neuropsychological measures. These are measured by the interaction effect between time of measurement (T0 versus T1, or T0 versus T2) and condition (experimental versus active control). If possible, parallel tests will be used to correct for repeated neuropsychological testing. The objectively measured intervention effect will be assessed on the most affected cognitive domain, different per syndrome:
- PD and postECT: improvement in executive functions, measured by change in the Trail Making Task
Measured: Baseline, 8 weeks and 12 weeks
Cognitive functioning (subjectively measured)
Change in subjective cognitive complaints as reported by the patient, measured by the Cognitive Failure Questionnaire (CFQ)
Measured: Baseline, 8 weeks and 12 weeks
Feasibility
The feasibility of the intervention as reported by the patients in a group session lead by patients from the disease associations.
Measured: Patients will be interviewed in a group session after study completion, an expected average of half a year
Stroop Color Word Task
Cognitive functioning as assessed by neuropsychological measures. These are measured by the interaction effect between time of measurement (T0 versus T1, or T0 versus T2) and condition (experimental versus active control). If possible, parallel tests will be used to correct for repeated neuropsychological testing. The objectively measured intervention effect will be assessed on the most affected cognitive domain, different per syndrome:
- PD and postECT: improvement in executive functions, measured by change in the Stroop Color Word Test.
Measured: Baseline, 8 weeks and 12 weeks
Letter Fluency
Cognitive functioning as assessed by neuropsychological measures. These are measured by the interaction effect between time of measurement (T0 versus T1, or T0 versus T2) and condition (experimental versus active control). If possible, parallel tests will be used to correct for repeated neuropsychological testing. The objectively measured intervention effect will be assessed on the most affected cognitive domain, different per syndrome:
- PD and postECT: improvement in executive functions, measured by change in the Letter Fluency.
Measured: Baseline, 8 weeks and 12 weeks
Rey Auditory Verbal Learning Test
Cognitive functioning as assessed by neuropsychological measures. These are measured by the interaction effect between time of measurement (T0 versus T1, or T0 versus T2) and condition (experimental versus active control). If possible, parallel tests will be used to correct for repeated neuropsychological testing. The objectively measured intervention effect will be assessed on the most affected cognitive domain, different per syndrome:
- MS: improvement in episodic memory, measured by change in the Rey Auditory Verbal Learning Test.
Measured: Baseline, 8 weeks and 12 weeks
Location Learning Test
Cognitive functioning as assessed by neuropsychological measures. These are measured by the interaction effect between time of measurement (T0 versus T1, or T0 versus T2) and condition (experimental versus active control). If possible, parallel tests will be used to correct for repeated neuropsychological testing. The objectively measured intervention effect will be assessed on the most affected cognitive domain, different per syndrome:
- MS: improvement in episodic memory, measured by change in the Location Learning Test.
Measured: Baseline, 8 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startMar 2016
- Primary completionJun 2017
- Study completion7 Jul 2017
Why it stopped: All Parkinson's disease patients have finished training. The MS and ECT groups have not finished as these groups had trouble including 20 patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Parnassia Bavo Groep, GGZ inGeest
- Responsible party
- Principal investigator, O.A. van den Heuvel, Amsterdam UMC, location VUmc
- Investigators
- Odile A. Van den Heuvel, MD PhD, Principal investigator, Amsterdam UMC, location VUmcChris Vriend, PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525367
- Sponsor's protocol ID
- CWO/15-10E
- Status last verified
- Aug 2017
- First submitted
- 6 Aug 2015
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Oudega ML, van Exel E, Wattjes MP, Comijs HC, Scheltens P, Barkhof F, Eikelenboom P, de Craen AJ, Beekman AT, Stek ML. White matter hyperintensities and cognitive impairment during electroconvulsive therapy in severely depressed elderly patients. Am J Geriatr Psychiatry. 2014 Feb;22(2):157-66. doi: 10.1016/j.jagp.2012.08.002. Epub 2013 Jan 11.
PubMed 23567440Chiaravalloti ND, DeLuca J. Cognitive impairment in multiple sclerosis. Lancet Neurol. 2008 Dec;7(12):1139-51. doi: 10.1016/S1474-4422(08)70259-X.
PubMed 19007738Bosboom JL, Stoffers D, Wolters ECh. Cognitive dysfunction and dementia in Parkinson's disease. J Neural Transm (Vienna). 2004 Oct;111(10-11):1303-15. doi: 10.1007/s00702-004-0168-1. Epub 2004 Jun 30.
PubMed 15480840Rubin EH, Kinscherf DA, Figiel GS, Zorumski CF. The nature and time course of cognitive side effects during electroconvulsive therapy in the elderly. J Geriatr Psychiatry Neurol. 1993 Apr-Jun;6(2):78-83. doi: 10.1177/089198879300600204.
PubMed 8512634Achiron A, Barak Y. Cognitive impairment in probable multiple sclerosis. J Neurol Neurosurg Psychiatry. 2003 Apr;74(4):443-6. doi: 10.1136/jnnp.74.4.443.
PubMed 12640060Muslimovic D, Post B, Speelman JD, Schmand B. Cognitive profile of patients with newly diagnosed Parkinson disease. Neurology. 2005 Oct 25;65(8):1239-45. doi: 10.1212/01.wnl.0000180516.69442.95.
PubMed 16247051Aarsland D, Andersen K, Larsen JP, Lolk A, Kragh-Sorensen P. Prevalence and characteristics of dementia in Parkinson disease: an 8-year prospective study. Arch Neurol. 2003 Mar;60(3):387-92. doi: 10.1001/archneur.60.3.387.
PubMed 12633150Hely MA, Reid WG, Adena MA, Halliday GM, Morris JG. The Sydney multicenter study of Parkinson's disease: the inevitability of dementia at 20 years. Mov Disord. 2008 Apr 30;23(6):837-44. doi: 10.1002/mds.21956.
PubMed 18307261Rao SM, Leo GJ, Bernardin L, Unverzagt F. Cognitive dysfunction in multiple sclerosis. I. Frequency, patterns, and prediction. Neurology. 1991 May;41(5):685-91. doi: 10.1212/wnl.41.5.685.
PubMed 2027484Klepac N, Trkulja V, Relja M, Babic T. Is quality of life in non-demented Parkinson's disease patients related to cognitive performance? A clinic-based cross-sectional study. Eur J Neurol. 2008 Feb;15(2):128-33. doi: 10.1111/j.1468-1331.2007.02011.x.
PubMed 18217883Fletcher P, Leake A, Marion MH. Patients with Parkinson's disease dementia stay in the hospital twice as long as those without dementia. Mov Disord. 2011 Apr;26(5):919. doi: 10.1002/mds.23573. Epub 2011 Mar 21. No abstract available.
PubMed 21425337Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley JP, Bergquist T, Azulay J, Cantor J, Ashman T. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil. 2011 Apr;92(4):519-30. doi: 10.1016/j.apmr.2010.11.015.
PubMed 21440699Olazaran J, Reisberg B, Clare L, Cruz I, Pena-Casanova J, Del Ser T, Woods B, Beck C, Auer S, Lai C, Spector A, Fazio S, Bond J, Kivipelto M, Brodaty H, Rojo JM, Collins H, Teri L, Mittelman M, Orrell M, Feldman HH, Muniz R. Nonpharmacological therapies in Alzheimer's disease: a systematic review of efficacy. Dement Geriatr Cogn Disord. 2010;30(2):161-78. doi: 10.1159/000316119. Epub 2010 Sep 10.
PubMed 20838046Hindle JV, Petrelli A, Clare L, Kalbe E. Nonpharmacological enhancement of cognitive function in Parkinson's disease: a systematic review. Mov Disord. 2013 Jul;28(8):1034-49. doi: 10.1002/mds.25377. Epub 2013 Feb 20.
PubMed 23426759Rosti-Otajarvi EM, Hamalainen PI. Neuropsychological rehabilitation for multiple sclerosis. Cochrane Database Syst Rev. 2011 Nov 9;(11):CD009131. doi: 10.1002/14651858.CD009131.pub2.
PubMed 22071863
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pilot Study in the Feasibility and Effect of Online Cognitive Training on Cognitive Functions in Patients With Parkinson's Disease, Multiple Sclerosis and Depressive Patients Treated With Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT02525367
- Acronym / sponsor ID
- CWO/15-10E
- Conditions
- Idiopathic Parkinson's Disease, Multiple Sclerosis, Elderly Post Electric Convulsive Therapy
- Keywords
- Parkinson's disease, Multiple Sclerosis, Depressed Elderly, Cognitive Dysfunction, Online Cognitive Training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: All Parkinson's disease patients have finished training. The MS and ECT groups have not finished as these groups had trouble including 20 patients.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Parnassia Bavo Groep, GGZ inGeest
- Study start
- Mar 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- 7 Jul 2017 (actual)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Parkinson's disease, Multiple Sclerosis and depressed patients treated with electroconvulsive therapy, cognitive dysfunction is prevalent. However, treatment of these dysfunctions is in its infancy.
The purpose of this study is 1) to assess the feasibility of a randomized controlled trial using an online computerized intervention for training cognitive abilities in the three patient groups and 2) to estimate the effect of the online training on objectively and subjectively measured cognitive functions.
The investigators hypothesize that patients using online cognitive training will improve more on cognitive functions, as compared to patients using an active control condition.
Detailed description
In neurodegenerative disorders and psychiatric disorders, cognitive dysfunction is frequently reported. In Parkinson's disease (PD), Multiple Sclerosis (MS) and patients treated with electroconvulsive therapy after a severe or therapy resistant depression (postECT), executive dysfunction, attention deficit or episodic/autobiographic memory deficit is prevalent. In MS and PD, these dysfunctions can appear already early in the disease. The majority of PD patients - lifetime prevalence is about 80% - develops PD dementia. In MS, about half of the patients experiences problems with cognitive functions. ECT is used to treat patients with severe and/or therapy resistant depression. However, 30-50% of these patients develops severe cognitive dysfunction. Recovery usually occurs within six months after ECT. However, performances remain below-average compared to norm groups and there are large individual differences. The cognitive difficulties in MS and PD have a significant negative influence on the quality of life. Cognitive dysfunction in PD is associated with decreased independent daily functioning, hospitalization and the development and severity of neuropsychiatric symptoms. Furthermore, in the clinic cognitive dysfunction has been reported to be one of the most dreadful side effects of ECT. However, effective treatment of the described cognitive dysfunction is still in its infancy.
Cognitive training is based upon the principle that plasticity of the brain can facilitate function improvement by intensive training. In several neurological diseases, cognitive training has shown significant improvement in cognitive functions. In MS and PD, earlier studies have been small, frequently without an adequately controlled design. Additionally, earlier cognitive training programs have frequently been executed in a health care organization, impairing patients to successfully attend all training sessions due to mobility impairments. Also, there are limited studies in the effects of cognitive training on improved functioning of daily living and neuropsychiatric symptoms like anxiety and depression. Given the fact that there is an absence in cognitive training studies in patients post-ECT, there is no knowledge about the ability of cognitive training to speed up the natural course.
Using this pilot study, the investigators aim to study the feasibility of a randomized controlled trial using an online computerized intervention for training cognitive abilities in three patient groups. By using a double-blinded, controlled study design, the investigators keep in mind limitations of earlier comparable studies. If this treatment proves to be feasible, and a rough estimated effect size is positive, a larger randomized controlled trial can be executed to study the effectivity of this treatment. When effects are positive, an online cognitive training programme could prove to be a cost-efficient intervention that is accessible at home - something which is important for patients with mobility problems. The investigators hypothesize that patients using online cognitive training will improve more on cognitive functions, as compared to patients using an active training condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PD-Experimental | Experimental | Behavioral: Online cognitive trainingPD patients using the online cognitive training for 8 weeks, 3 times a week |
| PD-Control | Active comparator | Behavioral: Active control conditionPD patients using the active control condition for 8 weeks, 3 times a week |
| MS-Experimental | Experimental | Behavioral: Online cognitive trainingMS patients using the online cognitive training for 8 weeks, 3 times a week |
| MS-Control | Active comparator | Behavioral: Active control conditionMS patients using the active control condition for 8 weeks, 3 times a week |
| postECT-Experimental | Experimental | Behavioral: Online cognitive trainingDepressed elderly treated with ECT patients using the online cognitive training for 8 weeks, 3 times a week |
| postECT-Control | Active comparator | Behavioral: Active control conditionDepressed elderly treated with ECT patients using the active control condition for 8 weeks, 3 times a week |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients have (access to) a computer with access to the Internet. Patients are capable of using a keyboard and computer mouse.
- Patients are willing to sign informed consent.
- A compilation score of executive functions (i.e. Stroop, Trail Making Task, Fluency) shows deficit, which lies between 1 and 2 standard deviation (SD) below the mean of healthy Dutch norm population.
- Patients are diagnosed with Parkinson's disease according to the United Kingdom Parkinson's Disease Society Brain Bank criteria.
- Patients are in Hoehn \& Yahr stadium < 4, and are medically stable during a month prior to the intervention. The medication will be attempted to remain stable for the remainder of the intervention.
Key exclusion criteria (12 listed)
- Indications for presence of dementia.
- Presence of traumatic brain injury.
- A psychiatric disorder (in the postECT group: other than unipolar depression).
- No history or presence of drug or alcohol abuse.
- Inability to undergo a neuropsychological assessment (e.g. due to fast fatigue, seeing problems or language barrier).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online cognitive trainingAlso: BrainGymmer, Dezzel Media B.V., The NetherlandsThe intervention is a computerized, online training programme which aims to train several cognitive abilities; especially the executive functions, attention, working memory and processing speed. The mental processes that are appealed to by the intervention are similar to processes that are trained in classic face-to-face training methods. Both the intervention protocol and the active control condition will contain several games that have the participant train cognitive functions/perform cognitive activities for 8 weeks, 3 times a week, 45-60 minutes each session. | Behavioural | MS-Experimental, PD-Experimental, postECT-Experimental |
| Active control conditionThe active control condition consists of cognitive activities that do not intend to train cognitive functions based on 'cristallized intelligence', such as trivia. Both the intervention protocol and the active control condition will contain several games that have the participant train cognitive functions/perform cognitive activities for 8 weeks, 3 times a week, 45-60 minutes each session. | Behavioural | MS-Control, PD-Control, postECT-Control |
Primary outcome
Feasibility
Time frame: 8 weeks
The feasibility of the intervention as reported by the patients on 4-point Likert scale items (T1)
7 secondary outcomes
Trail Making Task
Time frame: Baseline, 8 weeks and 12 weeks
Cognitive functioning (subjectively measured)
Time frame: Baseline, 8 weeks and 12 weeks
Feasibility
Time frame: Patients will be interviewed in a group session after study completion, an expected average of half a year
Stroop Color Word Task
Time frame: Baseline, 8 weeks and 12 weeks
Letter Fluency
Time frame: Baseline, 8 weeks and 12 weeks
Rey Auditory Verbal Learning Test
Time frame: Baseline, 8 weeks and 12 weeks
Location Learning Test
Time frame: Baseline, 8 weeks and 12 weeks
Results and safety
The study was stopped early (reason given: All Parkinson's disease patients have finished training. The MS and ECT groups have not finished as these groups had trouble including 20 patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Background: PubMed 23567440Oudega ML, van Exel E, Wattjes MP, Comijs HC, Scheltens P, Barkhof F, Eikelenboom P, de Craen AJ, Beekman AT, Stek ML. White matter hyperintensities and cognitive impairment during electroconvulsive therapy in severely depressed elderly patients. Am J Geriatr Psychiatry. 2014 Feb;22(2):157-66. doi: 10.1016/j.jagp.2012.08.002. Epub 2013 Jan 11.
- Background: PubMed 19007738Chiaravalloti ND, DeLuca J. Cognitive impairment in multiple sclerosis. Lancet Neurol. 2008 Dec;7(12):1139-51. doi: 10.1016/S1474-4422(08)70259-X.
- Background: PubMed 15480840Bosboom JL, Stoffers D, Wolters ECh. Cognitive dysfunction and dementia in Parkinson's disease. J Neural Transm (Vienna). 2004 Oct;111(10-11):1303-15. doi: 10.1007/s00702-004-0168-1. Epub 2004 Jun 30.
- Background: PubMed 8512634Rubin EH, Kinscherf DA, Figiel GS, Zorumski CF. The nature and time course of cognitive side effects during electroconvulsive therapy in the elderly. J Geriatr Psychiatry Neurol. 1993 Apr-Jun;6(2):78-83. doi: 10.1177/089198879300600204.
- Background: PubMed 12640060Achiron A, Barak Y. Cognitive impairment in probable multiple sclerosis. J Neurol Neurosurg Psychiatry. 2003 Apr;74(4):443-6. doi: 10.1136/jnnp.74.4.443.
- Background: PubMed 16247051Muslimovic D, Post B, Speelman JD, Schmand B. Cognitive profile of patients with newly diagnosed Parkinson disease. Neurology. 2005 Oct 25;65(8):1239-45. doi: 10.1212/01.wnl.0000180516.69442.95.
- Background: PubMed 12633150Aarsland D, Andersen K, Larsen JP, Lolk A, Kragh-Sorensen P. Prevalence and characteristics of dementia in Parkinson disease: an 8-year prospective study. Arch Neurol. 2003 Mar;60(3):387-92. doi: 10.1001/archneur.60.3.387.
- Background: PubMed 18307261Hely MA, Reid WG, Adena MA, Halliday GM, Morris JG. The Sydney multicenter study of Parkinson's disease: the inevitability of dementia at 20 years. Mov Disord. 2008 Apr 30;23(6):837-44. doi: 10.1002/mds.21956.
- Background: PubMed 2027484Rao SM, Leo GJ, Bernardin L, Unverzagt F. Cognitive dysfunction in multiple sclerosis. I. Frequency, patterns, and prediction. Neurology. 1991 May;41(5):685-91. doi: 10.1212/wnl.41.5.685.
- Background: PubMed 18217883Klepac N, Trkulja V, Relja M, Babic T. Is quality of life in non-demented Parkinson's disease patients related to cognitive performance? A clinic-based cross-sectional study. Eur J Neurol. 2008 Feb;15(2):128-33. doi: 10.1111/j.1468-1331.2007.02011.x.
- Background: PubMed 21425337Fletcher P, Leake A, Marion MH. Patients with Parkinson's disease dementia stay in the hospital twice as long as those without dementia. Mov Disord. 2011 Apr;26(5):919. doi: 10.1002/mds.23573. Epub 2011 Mar 21. No abstract available.
- Background: PubMed 21440699Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley JP, Bergquist T, Azulay J, Cantor J, Ashman T. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil. 2011 Apr;92(4):519-30. doi: 10.1016/j.apmr.2010.11.015.
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MediPD: An Online Mediterranean Diet Program for People Living With Parkinson's Disease
Parkinson Disease, Idiopathic
Recruiting
Ginger-PD: Ginger as a Modifier of Ghrelin Levels and Gut Function in Parkinson's Disease
REM Sleep Behavior Disorder, Parkinson s Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Odile A. Van den Heuvel, MD PhD principal investigator
Amsterdam UMC, location VUmc
Chris Vriend, PhD principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online cognitive training in people with Idiopathic Parkinson's Disease and Multiple Sclerosis, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: All Parkinson's disease patients have finished training. The MS and ECT groups have not finished as these groups had trouble including 20 patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02525367, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2017; AzTrials last refreshed its copy on 6 Nov 2026.