NCT02926820

Brief Summary

There is a paucity of investigation into effective interventions to enhance cognitive function and/or mitigate cognitive decline in individuals with Huntington disease (HD). This study targeted working memory (WM), which is the ability to actively hold information in the mind in order to perform complex mental tasks, given reports of WM dysfunction in patients with HD. The investigators examined the feasibility of conducting a 5-week WM training program (Cogmed). Patient adherence and treatment tolerance were assessed. In addition, preliminary evidence for the efficacy of this training program on targeted cognitive abilities was examined. Nine patients with pre-manifest or early stage HD underwent training. Patients were assessed before the intervention and one week after completion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
Last Updated

October 10, 2016

Status Verified

October 1, 2016

Enrollment Period

1.1 years

First QC Date

September 30, 2016

Last Update Submit

October 7, 2016

Conditions

Keywords

Huntington diseasecognitive rehabilitationcognitive dysfunction

Outcome Measures

Primary Outcomes (1)

  • Adherence to training (defined by completing the intervention within the recommended time frame)

    Adherence was defined as completion of at least 80% of the total 25 training sessions within 40 calendar days or less

    40 days

Secondary Outcomes (8)

  • Digit Span subtest from the Wechsler Memory Scales - third edition

    Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)

  • Spatial Span subtest from the Wechsler Memory Scales - third edition

    Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)

  • Auditory Working Memory from the Woodcock Johnson Tests of Cognitive Ability - third edition

    Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)

  • Symbol span subtest from the Wechsler Memory Scales - fourth edition, reported in raw score units (total correct responses)

    Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)

  • Verbal Fluency subtest from the Delis-Kaplan Executive Function System

    Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)

  • +3 more secondary outcomes

Other Outcomes (3)

  • Qualitative experiences of training program as reported by the patient

    Post-interview follow-up, up to 45 days following baseline visit

  • Tolerance (ratio of training time to breaks per day)

    Per session and through completion of training program, up to 40 days

  • Cogmed Improvement Index

    Through completion of training program, up to 40 days

Study Arms (1)

Cognitive training

EXPERIMENTAL

Participants will undergo five weeks of cognitive training using the Cogmed QM program. All patients complete the same intervention.

Behavioral: Cogmed QM

Interventions

Cogmed QMBEHAVIORAL

The intervention consisted of 25 Cogmed sessions, typically completed over a five week period (i.e. 5 days per week), with each session lasting between 40-50 minutes per day. The program consists of 12 exercises that target visuo-spatial or verbal working memory. At each training session, participants completed 8 of the 12 exercises (order selected by the user), with 15 trials per exercise. Cogmed QM is an adaptive program, wherein task difficulty is adjusted to performance on each trial. The level of difficulty adjusts continuously and automatically, ensuring that each session provides an engaging, challenging level of WM capacity. Breaks were permitted, and encouraged, at the participants' discretion throughout the session.

Cognitive training

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Laboratory-confirmed gene expansion of at least 36 CAG repeats
  • Reported working memory difficulties on the Patient-Reported Outcomes in Cognitive Impairment (PROCOG) questionnaire
  • Total Functional Capacity (TFC) score of at least 3, taken from the UHDRS
  • Montreal Cognitive Assessment (MOCA) score of 19 or greater

You may not qualify if:

  • History of head trauma/neurological event such as stroke
  • Untreated psychiatric symptoms or substance abuse
  • Visual or motor symptoms that would impede ability to complete the program and/or neuropsychological testing
  • Nonfluency in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North York General Hospital

Toronto, Ontario, M2K 1E1, Canada

Location

Related Publications (1)

  • Sadeghi M, Barlow-Krelina E, Gibbons C, Shaikh KT, Fung WLA, Meschino WS, Till C. Feasibility of computerized working memory training in individuals with Huntington disease. PLoS One. 2017 Apr 28;12(4):e0176429. doi: 10.1371/journal.pone.0176429. eCollection 2017.

MeSH Terms

Conditions

Huntington DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Christine Till, PhD

    York University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Psychology

Study Record Dates

First Submitted

September 30, 2016

First Posted

October 6, 2016

Study Start

February 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

October 10, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations