Assessment of Motor Reserve in the Preclinical Stages of Dementia

Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
Study ID
NCT07634055
Status
Recruiting
Apply to this trial

Conditions

  • Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Sensor-based medical device for kinematic assessment: Hand Test System (HTS) — DEVICE
    Participants will undergo a multidimensional assessment protocol aimed at investigating motor reserve in healthy individuals and patients with (MCI). The assessment will include clinical and neuropsychological evaluations, standardized motor tasks, and quantitative kinematic movement analysis using a sensor glove classified as a medical device, designed to record objective motor parameters during task execution. The collected measures will be used to characterize motor performance and to analyze its relationship with cognitive reserve, clinical status, and neuropsychological functioning. No therapeutic intervention or experimental treatment will be administered. All procedures will be performed exclusively for observational research purposes.

Study Details

Mild Cognitive Impairment (MCI) is a clinical condition associated with an increased risk of progression to dementia. Although cognitive alterations have traditionally been the main focus of investigation, growing evidence suggests that motor changes may also emerge during the early stages of cognitive decline and may represent potential preclinical indicators of disease. In this context, the concept of motor reserve has emerged as a construct of increasing interest, although it remains insufficiently defined. Understanding how motor characteristics may contribute to an individual's ability to compensate for or modulate the effects of cognitive decline could provide new insights into the mechanisms involved in the early stages of dementia. Therefore, the present monocentric observational study aims to further investigate the concept of motor reserve in healthy individuals and in patients with Mild Cognitive Impairment (MCI) through a multidimensional approach based on clinical, neuropsychological, behavioral, and kinematic assessments. In particular, standardized motor tasks and quantitative movement analyses using a sensor-based medical device will be employed to objectively characterize motor performance.The study plans to recruit approximately 200 participants, including healthy individuals and patients with MCI, enrolled at the Neuropsychology Outpatient Clinic of the Neurology Unit of the University Hospital "Renato Dulbecco" in Catanzaro. In the healthy group, the relationship between motor reserve and motor performance will be investigated, while in patients with MCI the relationship between cognitive reserve, motor reserve, clinical and neuropsychological status, and motor performance will be explored. The findings of this study may contribute to a broader and more operational definition of motor reserve and support the identification of potential motor biomarkers associated with early cognitive decline. These findings may ultimately contribute to the development of innovative strategies for the early detection and monitoring of conditions at risk of progression to dementia.

Key Dates

First listed
Jun 8, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: *Patients with MCI*
  • Arm: Healthy Controls

Primary Outcome Measure

Finger Tapping Metrics [ Time Frame: Baseline (single assessment) ]

Central Contacts

Related Studies