An observational study in Mild Cognitive Impairment (MCI), sponsored by Istituto per la Ricerca e l'Innovazione Biomedica. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Istituto per la Ricerca e l'Innovazione Biomedica · Observational
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.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 200 is above the median of 150 across 997 observational studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Istituto per la Ricerca e l'Innovazione Biomedica is the lead sponsor of 47 studies on the registry; 29 are open to participants now.
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The study population will consist of approximately 200 participants divided into two groups: 100 patients with Mild Cognitive Impairment (MCI) and 100 healthy control subjects. Participants will be recruited at the Neuropsychology Outpatient Clinic of the Neurology Unit, University Hospital "Renato Dulbecco", Pugliese Hospital, Catanzaro, Italy. MCI patients will be included according to international NIA-AA diagnostic criteria, while healthy subjects must show normal performance on neuropsychological screening. All participants will undergo clinical, anamnestic, and neuropsychological evaluation, followed by motor reserve assessment and kinematic evaluation at the IBSBC-CNR laboratories in Catanzaro using standardized motor tasks and a CE-marked sensor glove medical device. Written informed consent will be obtained from all participants or a legal representative, when applicable.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with Mild Cognitive Impairment (MCI) group
Healthy subjects group
Exclusion Criteria:
Patients with Mild Cognitive Impairment (MCI) group
-History of psychiatric or neurological disorders not attributable to MCI. Use of psychotropic medications.
Healthy subjects group
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Sensor-based medical device for kinematic assessment: Hand Test System (HTS)
Device: Sensor-based medical device for kinematic assessment: Hand Test System (HTS)
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.
Finger Tapping Metrics
Motor performance is assessed using a sensor-engineered glove that records the contact events between the thumb and the four fingers (index, middle, ring, little) on each hand independently, providing finger-level timing parameters for each sequence of taps.
Time frame: Baseline (single assessment)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Sep 2026, 2 months later.
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Istituto per la Ricerca e l'Innovazione Biomedica