Clinical trial NCT02926820: Working Memory Training in Huntington's Disease
Official title: Working Memory Training in Individuals With Huntington's Disease: A Pilot Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Huntington's Disease
Keywords: Huntington disease
cognitive rehabilitation
cognitive dysfunction
Lead sponsor: York University
Sponsor class: OTHER
Collaborators: name: North York General Hospital
First posted: 2016-10-06
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Huntington disease (HD) is associated with a variety of cognitive deficits, with prominent difficulties in working memory (WM). WM deficits are notably compromised in early-onset and prodromal HD patients. This study aimed to determine the feasibility of a computer-ized WM training program (Cogmed QM), novel to the HD population. Nine patients, aged 26-62, with early stage HD underwent a 25-session (5 days/week for 5 weeks) WM training program (Cogmed QM). Training exercises involved the manipulation and storage of verbal and visuospatial information, with difficulty adapted as a function of individual performance. Neuropsychological testing was conducted before and after training, and performance on criterion WM measures (Digit Span and Spatial Span) and near-transfer WM measures (Symbol Span and Auditory WM) were evaluated. Post-training inter-views about patient experience were thematically analyzed using NVivo software. Seven of nine patients demonstrated adherence to the training and completed all sessions within the recommended timeframe of 5 weeks. All adherent patients reported that they found training helpful (n=7), and almost all felt that their memory improved (n=6). Compared to baseline scores, patients showed significant improvement on the neuropsychological measures of verbal WM, including Digit Span (p = .047) and Auditory WM (p = .041). This pilot study provides support for feasibility of computerized WM training in early-stage patients with HD. Results suggest that HD patients can improve WM with intensive training, though a full-scale intervention project is needed to understand the reliability of changes over time.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Adherence to training (defined by completing the intervention within the recommended time frame)
timeFrame: 40 days
Secondary outcomes:
measure: Digit Span subtest from the Wechsler Memory Scales - third edition
timeFrame: Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)
measure: Spatial Span subtest from the Wechsler Memory Scales - third edition
timeFrame: Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)
measure: Auditory Working Memory from the Woodcock Johnson Tests of Cognitive Ability - third edition
timeFrame: Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)
measure: Symbol span subtest from the Wechsler Memory Scales - fourth edition, reported in raw score units (total correct responses)
timeFrame: Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)
measure: Verbal Fluency subtest from the Delis-Kaplan Executive Function System
timeFrame: Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)
measure: Symbol Digits Modalities Test (oral administration)
timeFrame: Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)
measure: Word List Learning from the Hopkins Verbal Learning Test -Revised
timeFrame: Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)
measure: Trail Making Test - Parts A and B
timeFrame: Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)
Other outcomes:
measure: Qualitative experiences of training program as reported by the patient
timeFrame: Post-interview follow-up, up to 45 days following baseline visit
measure: Tolerance (ratio of training time to breaks per day)
timeFrame: Per session and through completion of training program, up to 40 days
measure: Cogmed Improvement Index
timeFrame: Through completion of training program, up to 40 days
Locations:
city: Toronto
country: Canada
facility: North York General Hospital
state: Ontario
Study officials:
affiliation: York University
name: Christine Till, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.