Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06290167
Other study ID # 30M201
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 3, 2023
Est. completion date April 10, 2026

Study information

Verified date March 2024
Source Istituto Auxologico Italiano
Contact Elisa Pedroli, PsyD
Phone 02 61911 2707
Email e.pedroli@auxologico.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective of this project is two-fold 1. to develop a Dual-Task training exploiting the potentiality of the 360° technology in terms of interactivity and ecological validity 2. to investigate its efficacy in improving the cognitive functioning in a randomized clinical trial for 2 different populations: subjects with subjective memory complaints and mild cognitive impairment. Specifically, participants will follow an integrated training including 2 phases: 1)in-hospital rehabilitation, where subjects will be provided sessions of the training in immersive modality; 2)at-home rehabilitation, where older adults will be asked to perform at home the non-immersive version of the training using a tablet. Expected outcome is an improvement in cognitive functioning (assessed with a complete neuropsychological battery) after the training, thus advancing literature about non-pharmacological interventions in the preclinical stages of dementia along with innovative technical instruments.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date April 10, 2026
Est. primary completion date April 10, 2026
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria (group of SMC): - > 65 years old - self-reported memory complaints - score on Mini-Mental State Examination greater than or equal to 27/30 (normal range) Exclusion Criteria: - no evidence of objective impairments on the neuropsychological testing, scores on the Clinical Dementia Rating < 0.5 Inclusion Criteria (group of MCI): - > 65 years old - a self-reported (or reported by a caregiver) cognitive decline - an objective impairment on the neuropsychological testing - scores on the Clinical Dementia Rating < 0.5. Exclusion Criteria: - no dementia

Study Design


Related Conditions & MeSH terms


Intervention

Device:
360° media
sessions with head mounted display in hospital and sessions with tablet at home
Other:
Treatment As Usual (TAU)
sessions of TAU rehabilitation in hospital and sessions TAU rehabilitation at home
In hospital sessions
sessions will be carried out under the supervision of a therapist
at home sessions
sessions will be carried out without the supervision of a therapist
Mild Cognitive Impairment
half of this group will perform the protocol with 360° videos and the other half will perform the TAU
Subjective Memory Complain
half of this group will perform the protocol with 360° videos and the other half will perform the TAU

Locations

Country Name City State
Italy Istituto Auxologico Italiano IRCCS Milan MI

Sponsors (1)

Lead Sponsor Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cognitive functions Improvement in cognitive functioning assessed with a complete neuropsychological battery focused on different domains such as executive function, memory, and attention. Immediately after the training experience
Primary Motor functions Improvement in motor functioning assessed with specific test focused on balance, functional mobility, and walking speed Immediately after the training experience
See also
  Status Clinical Trial Phase
Completed NCT03228446 - The Effects of Attentional Filter Training on Working Memory N/A
Completed NCT04033419 - Memantine for Prevention of Cognitive Decline in Patients With Breast Cancer Phase 2
Terminated NCT05199142 - A Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SDI-118 in Elderly Male and Female Study Participants With Cognitive Decline Phase 1
Active, not recruiting NCT05290233 - Time Restricted Eating Plus Exercise for Weight Management N/A
Terminated NCT03337282 - Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
Unknown status NCT00696514 - Vitamin B12 and Folic Acid Supplementation for Preventing Fractures in Elderly People Phase 1
Completed NCT00110604 - The Effect of Folic Acid on Atherosclerosis, Cognitive Performance and Hearing N/A
Recruiting NCT06245005 - Preoperative Cognitive Reserve in Older Surgical Patients: A Feasibility Study
Recruiting NCT05014399 - Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
Active, not recruiting NCT05586750 - Statins in Reducing Events in the Elderly Mind (STAREE-Mind) Imaging Substudy Phase 4
Completed NCT04386902 - Evaluation of Cognitive State Using Neurosteer EEG System
Recruiting NCT06070818 - Healthy Body & Mind Program for Older Adults Living With Osteoarthritis and Cognitive Decline N/A
Completed NCT01669915 - A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline N/A
Completed NCT02814526 - Exercise in Adults With Mild Memory Problems N/A
Not yet recruiting NCT05928078 - A Home-based e-Health Intervention in the Elderly: MOVI-ageing N/A
Not yet recruiting NCT06252376 - Effects of Blood Pressure on Cognition and Cerebral Hemodynamics in PD N/A
Recruiting NCT06318377 - Peanuts and Neurocognitive / Cardiovascular Health in Black Individuals N/A
Recruiting NCT03839784 - Building a Platform for Precision Anesthesia in the Geriatric Surgical Patient
Completed NCT04537728 - My Healthy Brain: Preserving and Promoting Brain Health Through Evidence-based Practices N/A
Active, not recruiting NCT03370796 - Group Reminiscence Therapy for Elderly People With Cognitive Decline in Institutional Context N/A