NeuroMusic: A Randomised-Controlled Trial of a Music-Based Training Program for Memory Difficulties

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2023
INTERVENTION: Music‐based training programs: The goal for both music interventions is to complete 24 hours of group training over 12 weeks. All participants will be requested to attend a 2‐hour training session, once a week (minimum request of 80% participation). Lessons will be delivered by professional musicians from the Sydney Conservatorium of Music. Each session has been structured with an initial 15‐minute warm‐up followed by a short review of material (10‐min) and the remaining portion of the class will focus on learning and practising new skills and concepts. Participants will also have a 25‐minute socialisation opportunity at the end of each session. Participants are expected to achieve some repertoire each week and to work progressively on a larger repertoire. There will be no overall pressure on perfection, rather encouragement to attempt activities and participate. Instructors will focus on gradual levels of short‐term achievement. Each training program will take place at the Sydney Conservatorium of Music in groups of 10 to 12 for each intervention. Progress will be recorded for each participant during each class session. Practice outside of the training session will be encouraged but will not be mandatory. If participants decide to practice at home, they will be provided with weekly guidance and given access to support resources. Participants will be asked to record their practice (e.g. time spent, type of activity) in a workbook provided by the instructor. At week 12, participants will be invited to be part of an optional group performance. The first 90 participants will be invited to receive a 60 minute 3T MRI brain scan at baseline and 12 weeks post intervenion. a) Keyboard intervention (arm 1): Participants allocated to the keyboard intervention arm will CONDITION: Age‐associated memory impairment ; ; Age‐associated memory impairment Neurological ‐ Dementias PRIMARY OUTCOME: Efficacy of the music‐based training programs as assessed by changes in verbal memory performance measured by the Rey Auditory Verbal Learning Test (RAVALT) trial 7 score (number of correct answers after 20 minutes delay).[Baseline, 12‐weeks after randomization. ] SECONDARY OUTCOME: Amyloid‐ß values from blood test.[baseline and 12 weeks after intervention commencement.] Anxiety symptom severity (number of points) using the Geriatric Anxiety Scale (GAS). [12 weeks after intervention commencement. The model will also include the same test information collected at baseline, and 36 weeks after intervention commencement ] Default mode network (DMN) functional connectivity using resting state functional MRI in n=90.[Baseline and 12 weeks after intervention commencement.] Depressive symptom severity (number of points) using the 15‐items Geriatric Depression Scale (GDS‐15). [12 weeks after intervention commencement. The model will also include the same test information collected at baseline, and 36 weeks after intervention commencement ] Executive functioning composite (mean z‐score for all tests within this composite) as assessed by the DKEFS Colour Word Interference Test conditions 3 and 4 subtests z‐score, the TMT part B z‐score and Verbal fluency using the COWAT (letters F,A,S) z‐score. [12 weeks after intervention commencement. The model will also include the same test information collected at baseline, and 36 weeks after intervention commencement ] Exploratory outcome: Actigraphy markers (e.g., sleep efficiency, nocturnal awakenings, sleep timing and total sleep time) as assessed by an actigraphy watch. [Time point: 12 weeks after intervention commencement. The model will also include the same test information collected at baseline, and 36 weeks after intervention commencement. ] Exploratory outcome: Adherence to treatment as determined by a pre‐specified value of attendance of 80% of our music‐based training sessions, based on session attendance checklists. [12 weeks after intervention commencement] Exploratory outcome: Daily functioning (total number of points) as determined by the Healthy Brain Ageing – Functional Assessment Questionnaire (HBA‐FAQ). This will be administered to participants and one informant of each participant. [12 weeks after intervention commencement. The model will also include the same test information collected at baseline, and 36 weeks after intervention commencement ] Exploratory outcome: Engagement outside practice (total hours of practice) as assessed by self‐reported practice time outside of intervention attendance. This will be recorded in a practice diary. This outcome will be used as a mediator in the relationship between music intervention and MRI and cognitive outcomes. [12 weeks after intervention commencement. The model will also include the same information collected at baseline, and 36 weeks after intervention commencement ] Exploratory outcome: How much practice was completed assessed by self‐reported scores on a 10‐point Likert scale ranging from 1 to 10. This outcome will be used as a mediator in the relationship between music intervention and MRI and cognitive outcomes. [Weeks 1‐12 of intervention ] Exploratory outcome: Overall challenge of the class material as assessed by self‐reported scores on a 10‐point Likert scale ranging from 1 to 10. This outcome will be used as a mediator in the relationship between music intervention and MRI and cognitive outcomes. [Weeks 1‐12 of the intervention] Exploratory outcome: Overall motivation to come to class as assessed by self‐reported scores on a 10‐point Likert scale ranging from 1 to 10. This outcome will be used as a mediator in the relationship between music intervention and MRI and cognitive outcomes. [Weeks 1‐12 of the intervention. ] Exploratory outcome: Overall motivation to complete homework by self‐reported scores on a 10‐point Likert scale ranging from 1 to 10. This outcome will be used as a mediator in the relationship between music intervention and MRI and cognitive outcomes. [Weeks 1‐12 of the intervention] Exploratory outcome: Participant experience of the music‐based training program will be assessed by semi‐structured interviews and focus groups.[12 weeks after intervention commencement. The model will also include the same information collected at week 4, 8, and 36 after intervention commencement. ] Exploratory outcome: Participation frequency in cognitively stimulating activities (total number of points) as determine by the Cognitive Stimulating Activity Questionnaire (CSA‐Q). [12 weeks after intervention commencement. The model will also include the same test information collected at baseline, and 36 weeks after intervention commencement ] Exploratory outcome: Satisfaction of one’s own memory (total number of points) as assessed by the Satisfaction scale from the Multifactorial Memory Questionnaire (MMQ). [12 weeks after intervention commencement. The model will also include the same test information collected at baseline, and 36 weeks after intervention commencement ] Exploratory outcome: Self‐perception of everyday memory ability (total number of points) as assessed by the Ability scale from the Multifactorial Memory Questionnaire (MMQ). [12 weeks after intervention commencement. The model will also include the same test information collected at baseline, and 36 weeks after intervention commencement ] Exploratory outcome: Self‐report sleep efficiency (number of points from only component 4) as assessed by the Pittsburgh Sleep Quality Inde X(PSQI).[12 weeks after intervention commencement. The model will also include the same test information collected at baseline, and 36 weeks after intervention commencement] Exploratory outcome: Use of practical memory strategies (total number of points) as assessed by the Strategy scale from the Multifactorial Memory Questionnaire (MMQ). [12 weeks after intervention commencement. The model will also include the same test information collected at baseline, and 36 weeks after intervention commencement ] Glial fibrillary acidic protein (GFAP) values ((ng/mL) from blood test. [Baseline and 12 weeks after intervention commencement.] Global Cognition as assessed using Preclinical Alzheimer Cognitive Composite (PACC). The PACC will be a composite score derived from: the Rey Auditory Verbal Learning Test & Wechsler Logical Memory subtest (memory); Controlled Oral Word Association Test (phonemic and semantic fluency); WAIS‐IV Digit Span (working memory), the Symbol Digit modalities Test (processing speed) and the Oral Trail Making Test (executive functioning). These tests have been validated for use via videoconference. [12 weeks after intervention commencement. The model will also include the same test information collected at baseline, and 36 weeks after intervention commencement.] High‐sensitivity C ‐ reactive protein values (mg/L) from blood test. [Baseline and 12 weeks after intervention commencement.] Hippocampal volume (mm3) using Magnetic Resonance Imaging in n=90[Baseline and 12 weeks after intervention commencement.] Hippocampal white matter integrity using Magnetic Resonance Imaging in n=90[Baseline and 12 weeks after intervention commencement ] Neurofilament light chain (Nfl) values (pg/mL) from blood test. [Baseline and 12 weeks after intervention commencement] Overall health status (number of points) as assessed by the EuroQol 5‐dimension scale (EQ5D).[Time point: 12 weeks after intervention commencement. The model will also include the same test information collected at baseline, and 36 weeks after intervention commencement ] p‐tau‐181 values (ng/µL) from blood test. There will be a planned sub‐analysis of the primary outcome in only participants found to have p‐tau in their blood. There will be further exploratory analyses evaluating if changes in the blood outcomes are mediated by changes in the imaging outcomes. [Baseline and 12 weeks after intervention commencement.] p‐tau‐217 values (pg/mL) from blood test. [baseline and 12 weeks after intervention commencement] Parietal lobe cortical thickness (mm) using Magnetic Resonance Imaging in n=90. [Baseline and 12 weeks after intervention commencement ] Parietal lobe white matter integrity using Magnetic Resonance Imaging in n=90[Baseline and 12 weeks after intervention commencement ] Prefrontal lobe cortical thickness (mm) using Magnetic Resonance Imaging in n=90. [Baseline and 12 weeks after intervention commencement] Prefrontal lobe white matter integrity using Magnetic Resonance Imaging in n=90[Baseline and 12 weeks after intervention commencement.] Processing speed composite (mean z‐score for all tests within this composite) as measured by the DKEFS Colour Word Interference Test conditions 1 and 2 z‐score, and the Oral Trail‐Making Test (OTMT) part A z‐score. [12 weeks after intervention commencement. The model will also include the same test information collected at baseline, and 36 weeks after intervention commencement ] Self‐report sleep quality (total number of points) as assessed by the Pittsburgh Sleep Quality Inde X(PSQI). [12 weeks after intervention commencement. The model will also include the same test information collected at baseline, and 36 weeks after intervention commencement] Subjective cognitive complaints (number of points) as assessed by the British Columbia Cognitive Complaints Inventory. [12 weeks after intervention commencement. The model will also include the same test information collected at baseline, and 36 weeks after intervention commencement. ] Temporal lobe cortical thickness (mm3) using Magnetic Resonance Imaging in n=90[Baseline and 12 weeks after implementation commencement ] Temporal lobe white matter integrity using Magnetic Resonance Imaging in n=90[Baseline and 12 weeks after intervention commencement ] Verbal learning composite (mean z‐score for all tests within this composite) as determined by the Logical Memory I subtest z‐score of the Wechsler Memory Scale‐III (WMS‐III) and the Rey Auditory Verbal Learning Test (RAVLT) trials 1‐5 total z‐score. [12 weeks after intervention commencement. The model will also include the same test information collected at baseline, and 36 weeks after intervention commencement ] Verbal memory composite (mean z‐score for all tests within this composite) as assessed by the Logical Memory II subtest z‐score of the WMS‐III and the RAVLT trial 7 z‐score.[12 weeks after intervention commencement. The model will also include the same test information collected at baseline, and 36 weeks after intervention commencement ] INCLUSION CRITERIA: 1. Memory decline as defined by >1 standard deviation on any memory test perfomed at screening (i.e. RAVLT and/or Logical Memory) 2. Able to provide informed written consent. 3. Fluent English literacy. 4. Adults aged between 60‐80 years. 5. Appropriateness to be in a group setting.
Epistemonikos ID: 07a1e143eba57919373886e01eed8ea290d2512b
First added on: Feb 20, 2024