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

Stopped earlyNot a drug-phase studyMS (type not specified)NCT02525367

What it found

Stopped

The trial ended early for another reason (see below).

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.

This trial finished 9 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Online cognitive training

Compared with

  • Active control condition

What it measured

Main measures

  • Feasibility

    8 weeks

    MRI lesionsFeasibility

Other measures (7)

  • Trail Making Task

    Baseline, 8 weeks and 12 weeks

    MRI lesionsThinking and memory
  • Cognitive functioning (subjectively measured)

    Baseline, 8 weeks and 12 weeks

    Thinking and memory
  • Feasibility

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

    Feasibility
  • Stroop Color Word Task

    Baseline, 8 weeks and 12 weeks

    MRI lesionsThinking and memory
  • Letter Fluency

    Baseline, 8 weeks and 12 weeks

    MRI lesionsThinking and memory
  • Rey Auditory Verbal Learning Test

    Baseline, 8 weeks and 12 weeks

    MRI lesionsThinking and memory
  • Location Learning Test

    Baseline, 8 weeks and 12 weeks

    MRI lesionsThinking and memory

Who could take part

MS (type not specified) · 30 to 70

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Mar 2016

    2. Main results due

      Jun 2017

    3. Finished

      Jul 2017

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