Cognitive Impairment Clinical Trial
Official title:
MusiCare: Protecting Cognitive Functions and Wellbeing Using Music Therapy & Innovative Technology With an Aging Population
The number of older people living with cognitive impairment or dementia has increased the need for simple, inexpensive interventions to improve the quality of life for such individuals and their families. Policy-makers sensitive to issues associated with mental health challenges in aging have embraced social prescribing, and a wealth of research has flourished to study non-pharmacological forms of preventative intervention. Can music-therapy(MT) be one of them? Different studies demonstrated that music stimulates a range of cognitive and social functions. However, scientific studies assessing the value of MT for those who need support in later life are limited, and rigorous research is required to generate robust scientific evidence. The focus of this study is on developing novel forms of intervention for older adults who are healthy or experiencing mild-to-moderate cognitive decline, aiming at [i]understanding whether MT could be used in preventive programs to support cognitive functions, [ii]identifying the best match between types of MT and levels of cognitive decline. Moreover, recent developments of Robotic-Assistance-Technologies offer opportunities to explore how such technologies may be used to contribute to older adults wellbeing when integrated within care routines to facilitate MT delivery. Spanning across three-studies, the investigators will examine psychosocial benefits of 5-month MT interventions (one2one vs small-group MT) in healthy older adults and impaired older adults in care homes, compared to standard care. This latter group will receive MT afterwards. Further, researchers will investigate whether Robotic-Assistance-Technologies may enrich MT interventions and have additional benefits for the participants and translatability for community-based services. In order to measure these effects, psychological (cognitive functions, wellbeing, quality of life) and physiological (hormonal, cardiovascular & brain activity) measures will be compared before/after the intervention. The study will elucidate relationships between different types of MT and benefits to participants wellbeing, cognitive functions & social engagement, as well as the impact of robotic assistive technologies in public health services and social care.
The following objectives are addressed: [Oi] Identifying a consistent set of convergent measures for the reliable assessment of cognition/well-being in MT studies integrating psychological measures with biomarkers; [Oii] Implementing robust MT protocols benefitting cognitive functions/well-being in ageing individuals with varying cognitive ability; [Oiii] Comparing the outcomes of one2one/small-group MT intervention in function of participants' cognitive abilities (ranging from healthy ageing to moderate impairment); [Oiv] Devising, implementing and testing a robotic platform associated with MT to facilitate therapists/caregivers' work through novel forms of interaction with ageing individuals, and potential translatability to communities. Our research questions/hypotheses are: [H1] Will MT benefits healthy, mildly and moderately impaired 65+ in outcome measures? MT > standard care. [H2] Which MT treatment (one2one/small group) is more effective in function of older adults' cognitive level? Best outcomes predicted as follows: healthy 65+ with small-group MT; for mildly impaired 65+, one2one = small-group MT; moderately impaired 65+ with one2one MT. [H3] Will improvements in cognitive functions derived from MT be associated with psychophysiological biomarkers? Convergent measures will be identified linking cognitive, behavioural and physiological improvement. [H4] What are the benefits of MT for caregivers? A reduction in participant psychiatric and depressive symptoms will correspond to caregivers' workload and stress perception decrease. [H5] Are there benefits from enriching MT with robotic technology? Specifically, the investigators hypothesize that a) the robot will have the capability of delivering interactive music training sessions, with the support of caregivers not specialised in MT and b) the continuous monitoring provided by the robotic platform will enhance the information available to therapists/caregivers without significantly burdening them. MusiCare aims are: [Ai] Provide care-homes, communities and policy-makers with clear guidelines concerning the utility, suitability and cost-effectiveness of Music Therapy (MT) interventions (one2one vs small-group) as a prevention/rehabilitation method suitable for social prescribing and support for positive ageing. [Aii] Provide music therapists with robust protocols, new tests specifically designed to work through musical tasks (Music Cognitive Test). [Aiii] Provide scholars/practitioners with a range of objective measures to select from, depending on their needs, in order to evaluate MT interventions in ageing. [Aiv] Explore how the assistive robotic technologies can enrich MT in care-home settings by empowering care-home staff with a new active role in assisting rehabilitative activities as well as facilitating inter-generational communication between families and ageing relatives. [Av] Increase public awareness about healthy ageing, and arts & wellbeing. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02122198 -
Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women
|
N/A | |
Recruiting |
NCT04356924 -
Psychological Treatment to Support the Consequences of Cognitive Impairment
|
N/A | |
Suspended |
NCT05542238 -
The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury
|
N/A | |
Terminated |
NCT04493957 -
Evaluation of an Educational Program in the Prevention of the Driving Risks in Patients With Neurocognitive Disorders : ACCOMPAGNE
|
N/A | |
Recruiting |
NCT04792983 -
Cognition and the Immunology of Postoperative Outcomes
|
||
Completed |
NCT06029920 -
Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment
|
N/A | |
Not yet recruiting |
NCT05068323 -
Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients
|
N/A | |
Completed |
NCT04426838 -
Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad
|
N/A | |
Completed |
NCT04713384 -
Remote Bimanual Virtual Rehabilitation Post CVD
|
N/A | |
Recruiting |
NCT06284213 -
Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
|
||
Recruiting |
NCT06053775 -
Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Related to Breast Cancer (ONCODEP)
|
N/A | |
Completed |
NCT03698695 -
A Pharmacodynamics, Safety, and Pharmacokinetics Study of THN201 Versus Donepezil in Healthy Male Volunteers
|
Phase 1 | |
Not yet recruiting |
NCT05552729 -
Effects of Different Doses of Vitamin D on Cancer-related Cognitive Impairment in Patients With Gastrointestinal Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03268109 -
COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
|
||
Completed |
NCT03187353 -
IMProving Executive Function Study
|
Phase 4 | |
Completed |
NCT03301402 -
Air Purifier to Improve Endothelial Function and Carotid Intima Thickness
|
N/A | |
Completed |
NCT05395559 -
Prevalence and Recognition of Cognitive Impairment in Hospitalized Patients: a Flash Mob Study
|
||
Recruiting |
NCT04907565 -
Impact of Obesity on Post-operative Cognitive Dysfunction: Role of Adipose Tissue
|
||
Recruiting |
NCT05030285 -
Telehealth Psychotherapy for Anxiety in Persons With Cognitive Impairment
|
N/A | |
Recruiting |
NCT04897334 -
Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke
|
N/A |