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Online Cognitive Training in PD, MS and Depressed Patients Treated With Electroconvulsive Therapy

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ClinicalTrials.gov Identifier: NCT02525367
Recruitment Status : Terminated (All Parkinson's disease patients have finished training. The MS and ECT groups have not finished as these groups had trouble including 20 patients.)
First Posted : August 17, 2015
Last Update Posted : August 28, 2017
Sponsor:
Collaborators:
Parnassia Bavo Groep
GGZ inGeest
Information provided by (Responsible Party):
O.A. van den Heuvel, VU University Medical Center

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Idiopathic Parkinson's Disease Multiple Sclerosis Elderly Post Electric Convulsive Therapy Behavioral: Online cognitive training Behavioral: Active control condition Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : July 7, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PD-Experimental
PD patients using the online cognitive training for 8 weeks, 3 times a week
Behavioral: Online cognitive training
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.
Other Name: BrainGymmer, Dezzel Media B.V., The Netherlands

Active Comparator: PD-Control
PD patients using the active control condition for 8 weeks, 3 times a week
Behavioral: Active control condition
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.

Experimental: MS-Experimental
MS patients using the online cognitive training for 8 weeks, 3 times a week
Behavioral: Online cognitive training
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.
Other Name: BrainGymmer, Dezzel Media B.V., The Netherlands

Active Comparator: MS-Control
MS patients using the active control condition for 8 weeks, 3 times a week
Behavioral: Active control condition
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.

Experimental: postECT-Experimental
Depressed elderly treated with ECT patients using the online cognitive training for 8 weeks, 3 times a week
Behavioral: Online cognitive training
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.
Other Name: BrainGymmer, Dezzel Media B.V., The Netherlands

Active Comparator: postECT-Control
Depressed elderly treated with ECT patients using the active control condition for 8 weeks, 3 times a week
Behavioral: Active control condition
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.




Primary Outcome Measures :
  1. Feasibility [ Time Frame: 8 weeks ]
    The feasibility of the intervention as reported by the patients on 4-point Likert scale items (T1)


Secondary Outcome Measures :
  1. Trail Making Task [ Time Frame: Baseline, 8 weeks and 12 weeks ]

    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


  2. Cognitive functioning (subjectively measured) [ Time Frame: Baseline, 8 weeks and 12 weeks ]
    Change in subjective cognitive complaints as reported by the patient, measured by the Cognitive Failure Questionnaire (CFQ)

  3. Feasibility [ Time Frame: Patients will be interviewed in a group session after study completion, an expected average of half a year ]
    The feasibility of the intervention as reported by the patients in a group session lead by patients from the disease associations.

  4. Stroop Color Word Task [ Time Frame: Baseline, 8 weeks and 12 weeks ]

    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.


  5. Letter Fluency [ Time Frame: Baseline, 8 weeks and 12 weeks ]

    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.


  6. Rey Auditory Verbal Learning Test [ Time Frame: Baseline, 8 weeks and 12 weeks ]

    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.


  7. Location Learning Test [ Time Frame: Baseline, 8 weeks and 12 weeks ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.
  • 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.

Exclusion Criteria:

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).

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.


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): NCT02525367


Locations
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Netherlands
VU University Medical Center
Amsterdam, North-Holland, Netherlands, 1118
Sponsors and Collaborators
VU University Medical Center
Parnassia Bavo Groep
GGZ inGeest
Investigators
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Principal Investigator: Odile A. Van den Heuvel, MD PhD VU University Medical Center
Principal Investigator: Chris Vriend, PhD VU University Medical Center
Publications:

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Responsible Party: O.A. van den Heuvel, Mw. O.A. van den Heuvel, MD PhD, VU University Medical Center
ClinicalTrials.gov Identifier: NCT02525367    
Other Study ID Numbers: CWO/15-10E
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017
Keywords provided by O.A. van den Heuvel, VU University Medical Center:
Parkinson's disease
Multiple Sclerosis
Depressed Elderly
Cognitive Dysfunction
Online Cognitive Training
Additional relevant MeSH terms:
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Parkinson Disease
Multiple Sclerosis
Sclerosis
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases