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

Primary Purpose

Idiopathic Parkinson's Disease, Multiple Sclerosis, Elderly Post Electric Convulsive Therapy

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Online cognitive training
Active control condition
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Parkinson's Disease focused on measuring Parkinson's disease, Multiple Sclerosis, Depressed Elderly, Cognitive Dysfunction, Online Cognitive Training

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VU University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

PD-Experimental

PD-Control

MS-Experimental

MS-Control

postECT-Experimental

postECT-Control

Arm Description

PD patients using the online cognitive training for 8 weeks, 3 times a week

PD patients using the active control condition for 8 weeks, 3 times a week

MS patients using the online cognitive training for 8 weeks, 3 times a week

MS patients using the active control condition for 8 weeks, 3 times a week

Depressed elderly treated with ECT patients using the online cognitive training for 8 weeks, 3 times a week

Depressed elderly treated with ECT patients using the active control condition for 8 weeks, 3 times a week

Outcomes

Primary Outcome Measures

Feasibility
The feasibility of the intervention as reported by the patients on 4-point Likert scale items (T1)

Secondary Outcome Measures

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
Cognitive functioning (subjectively measured)
Change in subjective cognitive complaints as reported by the patient, measured by the Cognitive Failure Questionnaire (CFQ)
Feasibility
The feasibility of the intervention as reported by the patients in a group session lead by patients from the disease associations.
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.
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.
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.
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.

Full Information

First Posted
August 6, 2015
Last Updated
August 25, 2017
Sponsor
Amsterdam UMC, location VUmc
Collaborators
Parnassia Bavo Groep, GGZ inGeest
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1. Study Identification

Unique Protocol Identification Number
NCT02525367
Brief Title
Online Cognitive Training in PD, MS and Depressed Patients Treated With Electroconvulsive Therapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
March 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
July 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
Collaborators
Parnassia Bavo Groep, GGZ inGeest

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson's Disease, Multiple Sclerosis, Elderly Post Electric Convulsive Therapy
Keywords
Parkinson's disease, Multiple Sclerosis, Depressed Elderly, Cognitive Dysfunction, Online Cognitive Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PD-Experimental
Arm Type
Experimental
Arm Description
PD patients using the online cognitive training for 8 weeks, 3 times a week
Arm Title
PD-Control
Arm Type
Active Comparator
Arm Description
PD patients using the active control condition for 8 weeks, 3 times a week
Arm Title
MS-Experimental
Arm Type
Experimental
Arm Description
MS patients using the online cognitive training for 8 weeks, 3 times a week
Arm Title
MS-Control
Arm Type
Active Comparator
Arm Description
MS patients using the active control condition for 8 weeks, 3 times a week
Arm Title
postECT-Experimental
Arm Type
Experimental
Arm Description
Depressed elderly treated with ECT patients using the online cognitive training for 8 weeks, 3 times a week
Arm Title
postECT-Control
Arm Type
Active Comparator
Arm Description
Depressed elderly treated with ECT patients using the active control condition for 8 weeks, 3 times a week
Intervention Type
Behavioral
Intervention Name(s)
Online cognitive training
Other Intervention Name(s)
BrainGymmer, Dezzel Media B.V., The Netherlands
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active control condition
Intervention Description
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 Measure Information:
Title
Feasibility
Description
The feasibility of the intervention as reported by the patients on 4-point Likert scale items (T1)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Trail Making Task
Description
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
Time Frame
Baseline, 8 weeks and 12 weeks
Title
Cognitive functioning (subjectively measured)
Description
Change in subjective cognitive complaints as reported by the patient, measured by the Cognitive Failure Questionnaire (CFQ)
Time Frame
Baseline, 8 weeks and 12 weeks
Title
Feasibility
Description
The feasibility of the intervention as reported by the patients in a group session lead by patients from the disease associations.
Time Frame
Patients will be interviewed in a group session after study completion, an expected average of half a year
Title
Stroop Color Word Task
Description
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.
Time Frame
Baseline, 8 weeks and 12 weeks
Title
Letter Fluency
Description
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.
Time Frame
Baseline, 8 weeks and 12 weeks
Title
Rey Auditory Verbal Learning Test
Description
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.
Time Frame
Baseline, 8 weeks and 12 weeks
Title
Location Learning Test
Description
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.
Time Frame
Baseline, 8 weeks and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Odile A. Van den Heuvel, MD PhD
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chris Vriend, PhD
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Principal Investigator
Facility Information:
Facility Name
VU University Medical Center
City
Amsterdam
State/Province
North-Holland
ZIP/Postal Code
1118
Country
Netherlands

12. IPD Sharing Statement

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

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