Pilot Study to Determine if Working Memory Training Aids Cognitive Functioning in Patients With Parkinson's Disease

NCT01647698 | Unknown

• 1 other identifier: PDWM-2012-07
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This project will investigate the feasibility and preliminary effectiveness of an intensive and focused working memory training program for patients in the early stages of PD receiving dopaminergic therapy. The investigators hypothesize that working memory training will be an effective method of improving working memory and related cognitive and behavioural functions in PD patients.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; near transfer; far transfer; working memory; fluid intelligence; cognitive training; dual n-back

Outcome Measures

Primary Outcomes (4)

• Baseline Working memory function

  Working memory will be measured using the operation span task, the symmetry span task and the Sternberg memory scanning tasks. Operation span - This is a dual-task in which participants complete mathematical reasoning (e.g. solving a mathematical equation) while using short-term verbal memory to remember words. Symmetry span: This is a dual task in which participants discriminate about the symmetry of visual stimuli while using short-term spatial memory to remember the locations of stimuli. Sternberg memory scanning task - number memory test

  baseline

• Change in working memory function between baseline and 5 weeks post training onset

  5 weeks post training onset

• Change in working memory function between baseline and 10 weeks post training onset

  10 weeks post training onset

• Change in working memory function between baseline and 22 weeks post training onset

  22 weeks post training onset

Secondary Outcomes (8)

• Baseline fluid intelligence

  Baseline

• change in fluid intelligence between baseline and 5 weeks post training onset

  5 weeks post training onset

• Change in fluid intelligence between baseline and 10 weeks post training onset

  10 weeks post training onset

• Change in fluid intelligence between baseline and 22 weeks post training onset

  22 weeks post training onset

• Baseline Executive functioning

  Baseline

Study Arms (3)

Early training group

EXPERIMENTAL

The early training group will consist of 10 randomly assigned participants who will begin the adaptive working memory training task immediately after baseline assessment. They will continue training on the adaptive working memory training task for 5 weeks, after which they will continue for 5 weeks using a non-adaptive working memory task (active control task).

Behavioral: Adaptive working memory training task; Behavioral: Non-adaptive working memory training task (i.e. an active control task)

Late training group

EXPERIMENTAL

The late training group will consist of 10 randomly assigned participants who will engage in a non-adaptive working memory training task (i.e. an active control task) immediately after baseline assessment for 5 weeks. After the initial 5 weeks of the active control task they will then switch to the adaptive working memory task (the intervention) for 5 weeks. This is a randomized controlled cross-over design.

Behavioral: Adaptive working memory training task; Behavioral: Non-adaptive working memory training task (i.e. an active control task)

No training group

PLACEBO COMPARATOR

The no training group will engage in no training over the course of the pilot study, but will still participate in baseline, 5 week, 10 . This will allow us to determine if changes in the outcome and assessment variables are due to the working memory training or progression in the disease itself.

Behavioral: No training

Interventions

Adaptive working memory training task BEHAVIORAL

The working memory training task will consist of an adaptive working memory computer program that will test and extend patients' working memory capacity. Adaptive refers to the increase in the number of items that the patient is required to remember.

Early training group; Late training group

Non-adaptive working memory training task (i.e. an active control task) BEHAVIORAL

Active control task will consist of a non-adaptive working memory task.

Early training group; Late training group

No training BEHAVIORAL

No training during the experiment.

No training group

Eligibility Criteria

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

You may qualify if:

• clinical diagnosis of idiopathic Parkinson's disease
• self-reported concerns about their working memory, or working memory deficits that were identified by a clinical examination
• be classified as Hohn \& Yahr Stage 1 or 2
• be receiving a stable dose of dopaminergic therapy

You may not qualify if:

• presence of dementia or other significant neurological or psychiatric conditions, as determined by clinical history
• Classification as Hohm \& Yahr Stage 3 or 4
• Not on a stable dos of dopaminergic therapy

Sponsors & Collaborators

• Gail Eskes: lead
• Nova Scotia Health Authority: collaborator

Study Sites (1)

Dalhousie University

Halifax, Nova Scotia, Canada

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Gail Eskes, PhD

  Dalhousie University

  STUDY DIRECTOR

• Raymond Klein, PhD

  Dalhousie University

  STUDY CHAIR

• David Westwood, PhD

  Dalhousie University

  STUDY CHAIR

• Stephanie Jones, PhD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Gail Eskes

Study Record Dates

• First Submitted: July 13, 2012
• First Posted: July 23, 2012
• Study Start: October 1, 2013
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 19, 2023

Record last verified: 2023-05

Locations

CA (1)