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

NCT02525367 | Terminated

• 1 other identifier: CWO/15-10E
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Feasibility

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

  8 weeks

Secondary Outcomes (7)

• Trail Making Task

  Baseline, 8 weeks and 12 weeks

• Cognitive functioning (subjectively measured)

  Baseline, 8 weeks and 12 weeks

• Feasibility

  Patients will be interviewed in a group session after study completion, an expected average of half a year

• Stroop Color Word Task

  Baseline, 8 weeks and 12 weeks

• Letter Fluency

  Baseline, 8 weeks and 12 weeks

Study Arms (6)

PD-Experimental

EXPERIMENTAL

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

Behavioral: Online cognitive training

PD-Control

ACTIVE COMPARATOR

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

Behavioral: Active control condition

MS-Experimental

EXPERIMENTAL

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

Behavioral: Online cognitive training

MS-Control

ACTIVE COMPARATOR

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

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

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

Behavioral: Active control condition

Interventions

Online cognitive training BEHAVIORAL

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.

Also known as: BrainGymmer, Dezzel Media B.V., The Netherlands

MS-Experimental; PD-Experimental; postECT-Experimental

Active control condition BEHAVIORAL

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.

MS-Control; PD-Control; postECT-Control

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Parnassia Bavo Groep: collaborator
• GGZ inGeest: collaborator

Study Sites (1)

VU University Medical Center

Amsterdam, North Holland, 1118, Netherlands

Location

Related Publications (17)

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MeSH Terms

Conditions

Parkinson Disease; Multiple Sclerosis; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Odile A. Van den Heuvel, MD PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

• Chris Vriend, PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mw. O.A. van den Heuvel, MD PhD

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 17, 2015
• Study Start: March 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 7, 2017
• Last Updated: August 28, 2017

Record last verified: 2017-08

Locations

NL (1)