Working Memory Training in Huntington's Disease

Huntington's Disease Clinical Trial

Official title:

Working Memory Training in Individuals With Huntington's Disease: A Pilot Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02926820
• Other study ID #: NYGH 15-0001
• Status: Completed
• Phase: N/A
• First received: September 30, 2016
• Last updated: October 7, 2016
• Start date: February 2015
• Est. completion date: March 2016

Study information

• Verified date: October 2016
• Source: York University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Huntington Disease
• Huntington's Disease

Intervention

Behavioral:
• Cogmed QM
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.

Locations

Country	Name	City	State
Canada	North York General Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
York University	North York General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative experiences of training program as reported by the patient	Keywords were used to elicit themes that were indicative of participant attitude and motivation for training	Post-interview follow-up, up to 45 days following baseline visit	No
Other	Tolerance (ratio of training time to breaks per day)	To assess tolerance, the ratio of active training time to breaks per day was examined (Cogmed guidelines suggest at most a 2:1 ratio of active training time and breaks per sessions).	Per session and through completion of training program, up to 40 days	No
Other	Cogmed Improvement Index	The Improvement Index represents average improvement over the course of the training. It is calculated automatically by the program by subtracting the Start Index (score on third day of training) from the Max Index (best score throughout training).	Through completion of training program, up to 40 days	No
Primary	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	No
Secondary	Digit Span subtest from the Wechsler Memory Scales - third edition	This test is used as a criterion measure (i.e. measure that closely resembles tasks in the Cogmed program). Scores will be reported in raw score units as the total correct responses.	Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)	No
Secondary	Spatial Span subtest from the Wechsler Memory Scales - third edition	This test is used as a criterion measure (i.e. measure that closely resembles tasks in the Cogmed program). Scores will be reported in raw score units as the total correct responses.	Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)	No
Secondary	Auditory Working Memory from the Woodcock Johnson Tests of Cognitive Ability - third edition	This test is used as a near transfer measure (i.e. test of verbal or visuospatial working memory that include stimuli that are similar to trained tasks). Scores will be reported in raw score units (total correct responses)	Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)	No
Secondary	Symbol span subtest from the Wechsler Memory Scales - fourth edition, reported in raw score units (total correct responses)	This test is used as a near transfer measure (i.e. test of verbal or visuospatial working memory that include stimuli that are similar to trained tasks). Scores will be reported in raw score units (total correct responses)	Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)	No
Secondary	Verbal Fluency subtest from the Delis-Kaplan Executive Function System	This tests is used as a control task (i.e tests that do not directly assess working memory). Score will be reported in raw score units (total words produced)	Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)	No
Secondary	Symbol Digits Modalities Test (oral administration)	This tests is used as a control task (i.e tests that do not directly assess working memory). Score will be reported in raw score units (total words produced)	Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)	No
Secondary	Word List Learning from the Hopkins Verbal Learning Test -Revised	This tests is used as a control task (i.e tests that do not directly assess working memory). Score will be reported in raw score units (total words learned)	Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)	No
Secondary	Trail Making Test - Parts A and B	This tests is used as a control task (i.e tests that do not directly assess working memory). Score will be reported in raw score units (total time in seconds)	Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)	No