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

August 25, 2017 updated by: O.A. van den Heuvel, Amsterdam UMC, location VUmc

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • North-Holland
      • Amsterdam, North-Holland, Netherlands, 1118
        • VU University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: 8 weeks
The feasibility of the intervention as reported by the patients on 4-point Likert scale items (T1)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 8 weeks and 12 weeks
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)
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
The feasibility of the intervention as reported by the patients in a group session lead by patients from the disease associations.
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

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.
Baseline, 8 weeks and 12 weeks
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.
Baseline, 8 weeks and 12 weeks
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.
Baseline, 8 weeks and 12 weeks
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.
Baseline, 8 weeks and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amsterdam UMC, location VUmc

Collaborators

GGZ inGeest
Parnassia Bavo Groep

Investigators

  • Principal Investigator: Odile A. Van den Heuvel, MD PhD, Amsterdam UMC, location VUmc
  • Principal Investigator: Chris Vriend, PhD, Amsterdam UMC, location VUmc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2016

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

July 7, 2017

Study Registration Dates

First Submitted

August 6, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (ESTIMATE)

August 17, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2017

Last Update Submitted That Met QC Criteria

August 25, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CWO/15-10E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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