Skip to content

Feasibility study of HD-DRUM - a novel drumming training app for people with Huntington's disease

Feasibility randomised controlled pilot study of HD-DRUM - a novel motor activity (drumming) training app for people with Huntington's disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11906973
Enrollment
50
Registered
2022-05-09
Start date
2023-01-01
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improving cognitive and motor symptoms with drumming in people with Huntington's disease Nervous System Diseases

Interventions

The study will take place at the Cardiff University Brain Research Imaging Centre (CUBIRC) and at participants’ homes. Half of the participants (n = 25) will be randomised to receive HD-DRUM at home w

Sponsors

Cardiff University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 06/02/2024: Individuals over the age of 18 years with premanifest or early/moderate manifest HD as confirmed by genetic testing for the presence of the mutant huntingtin allele with a Total Functional Capacity score between 9 and 13, sufficient motor control to perform drumming and on stable medication for a minimum of four weeks prior to enrolment. Previous inclusion criteria: Individuals over the age of 18 years with premanifest or early/moderate manifest HD as confirmed by genetic testing for the presence of the mutant huntingtin allele with sufficient motor control to perform drumming and on stable medication for a minimum of four weeks prior to enrolment. They will have participated in at least two cognitive testing sessions for the ENROLL-HD registry to reduce the burden (cognitive data collected within a month prior to pilot will be used as baseline data) and practice effects of repeated testing.

Exclusion criteria

Exclusion criteria: A history of any other neurological condition than HD and an inability to provide consent.

Design outcomes

Primary

MeasureTime frame
1. Feasibility of recruitment will be assessed by recording the number of participants enrolled and consented into the study per clinic per month. 2. Retention will be measured by the number of participants who complete the study. Number and study and non-study-related reasons for drop-out will be recorded. 3. Acceptability will be measured with a semi-quantitative self-report questionnaire asking participants to rate how engaging/motivating/frustrating the training was, whether the training frequency, duration, and difficulty was appropriate, whether they perceived any beneficial/detrimental training effects, what they liked/disliked and what aspects could be improved. This information will provide feedback for any adjustments that may need to be made to HD-DRUM in preparation for a future RCT. 4. Adherence to the training will be automatically tracked with HD-DRUM by recording the frequency and duration of training sessions.

Secondary

MeasureTime frame
1. Computer and Paper based cognitive and motor tasks Training-induced transfer effects to untrained motor and cognitive tasks will be estimated with paper and pencil and computerised tasks to test motor and cognitive functions at baseline and follow-up study visits. These include tasks from the core-assessment protocol of the ENROLL-HD study and computerised tasks from the Psychology Experiment Building Language (PEBL) Test library. The pace of cognitive assessments will be led by the participant although it is not expected that the completion of the cognitive tasks will exceed 2 hours. The following tasks were chosen for the purpose of identifying the best clinical outcome measure for a future RCT. 1.1. Motor functions will be assessed with the Motor Score and the Diagnostic Confidence Index from the United Huntington’s Disease Rating Scale (UHDRS) and with a computerised finger tapping task from PEBL. 1.2. Everyday functioning will be assessed with the Total Functional Capacity, the Functional Assessment Scale and the Independence Scale from UHDRS. 1.3. Cognition will be assessed with the Symbol Digit Modality Test, Stroop word reading, Stroop colour naming and interference, letter and category fluency and Trail Making A & B from the core-assessment of ENROLL-HD. Executive functions of distractor suppression (Flanker task), updating (n-back), attention switching (complex span) and dual tasks will be assessed with PEBL. 2. MRI morphology and microstructure Brain morphology and microstructure of cortico-striatal-thalamic and cerebellar networks will be assessed at baseline and at 3 months follow-up to assess training-induced brain plasticity mechanisms. MRI scanning will be done on the National Microstructural Imaging Facility, a 3 Tesla MRI Siemens Connectom system with ultra-strong (300mT/m) gradients. MRI data acquisition time on the Connectom scanner will be ~60 min and optional additional scanning on the 7T Magnetom will be ~30 min: 2.1. T1-weighted anatomic

Countries

England, United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 11, 2026