Huntington's DiseaseNCT02926820
Working Memory Training in Huntington's Disease
A study testing Cogmed QM in people with Huntington's Disease, run by York University at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Huntington's Disease
- What is being tested?
- Cogmed QM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Working Memory Training in Individuals With Huntington's Disease: A Pilot Project
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.
Read the 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.
- Conditions
- Huntington's Disease
- Being tested
- Cogmed QM
- Keywords
- Huntington disease, cognitive rehabilitation, cognitive dysfunction
- Medical subject headings
- Huntington Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cogmed QMBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive training | Experimental | Participants will undergo five weeks of cognitive training using the Cogmed QM program. All patients complete the same intervention. Receives: Behavioral: Cogmed QM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 40 days
Secondary outcomes (8)
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.
Measured: Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)
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.
Measured: 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
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)
Measured: 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)
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)
Measured: Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)
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)
Measured: Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)
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)
Measured: Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)
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)
Measured: Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)
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)
Measured: Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startFeb 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Huntington's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Collaborators
- North York General Hospital
- Responsible party
- Principal investigator, Christine Till, York University
- Investigators
- Christine Till, PhD, Principal investigator, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926820
- Sponsor's protocol ID
- NYGH 15-0001
- Status last verified
- Oct 2016
- First submitted
- 30 Sep 2016
- Last updated
- 10 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28453532
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Working Memory Training in Individuals With Huntington's Disease: A Pilot Project
- ClinicalTrials.gov ID
- NCT02926820
- Acronym / sponsor ID
- NYGH 15-0001
- Conditions
- Huntington's Disease
- Keywords
- Huntington disease, cognitive rehabilitation, cognitive dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Collaborators
- North York General Hospital
- Study start
- Feb 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive training | Experimental | Behavioral: Cogmed QMParticipants will undergo five weeks of cognitive training using the Cogmed QM program. All patients complete the same intervention. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cogmed QMThe 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. | Behavioural | Cognitive training |
Primary outcome
Adherence to training (defined by completing the intervention within the recommended time frame)
Time frame: 40 days
Adherence was defined as completion of at least 80% of the total 25 training sessions within 40 calendar days or less
8 secondary outcomes
Digit Span subtest from the Wechsler Memory Scales - third edition
Time frame: Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)
Spatial Span subtest from the Wechsler Memory Scales - third edition
Time frame: 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
Time frame: 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)
Time frame: Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)
Verbal Fluency subtest from the Delis-Kaplan Executive Function System
Time frame: Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)
Symbol Digits Modalities Test (oral administration)
Time frame: Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)
Word List Learning from the Hopkins Verbal Learning Test -Revised
Time frame: Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)
Trail Making Test - Parts A and B
Time frame: Baseline (time 0) versus Post-intervention test score (up to 45 days post-baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2016.
- Derived from this study: PubMed 28453532Sadeghi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Till, PhD principal investigator
York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cogmed QM in people with Huntington's Disease, run by York University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to training (defined by completing the intervention within the recommended time frame) (time frame: 40 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02926820, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2016.