Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657274
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-23
Brief Title:
EARLY-COGN3 - Smart Digital Solutions for EARLY Treatment of COGnitive Disability a Neuropsychological Neurophysiological and Neurobiological Perspective in Chronic Neurological Diseases - PNRR-MCNT2-2023-12377069
Sponsor:
None
Organization:
None
Study Overview
Official Title:
EARLY-COGN3 - Smart Digital Solutions for EARLY Treatment of COGnitive Disability a Neuropsychological Neurophysiological and Neurobiological Perspective in Chronic Neurological Diseases - PNRR-MCNT2-2023-12377069
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EARLY-COGN3
Brief Summary:
The increase in life expectancy in recent decades has led to a large number of people living into old age and an increased risk of developing Chronic Neurological Diseases CNDs such as neurodegenerative diseases A higher cumulative risk of dementia has been largely demonstrated in Mild Cognitive Impairment MCI and Subjective Cognitive Complaints SCCs subjects and in Parkinsons Disease PD patients as compared to the general population These disorders result in an impairment of the individuals abilities to perform daily tasks As their disease progresses patients become dependent on medical services and on family support Given the limited effectiveness of pharmacological treatments non-pharmacological interventions to prevent and treat cognitive deficits and the associated difficulties with activities of daily living in neurodegenerative disease patients have gained attention in recent years and among these cognitive training offers a potential approach for dementia prevention and improvement of cognitive function A critical aspect of cognitive training programmes is that the most promising interventions have involved intensive in-person sessions that are unlikely to be cost-effective or feasible for large scale implementation Within the framework of non-pharmacological interventions the use of technology to assist the person at risk andor with mild dementia at home and to extend rehabilitation services in the treatment of dementia has gradually gained importance Telerehabilitation technologies allow to provide services remotely in patients homes allowing access to health care to patients living in rural settings or with mobility difficulties In addition the telerehabilitation modality offers the advantage of providing rehabilitation within the natural environment of the patients home making the treatment more realistic and possibly more generalizable to the persons daily life The present project proposes to test a home-based asynchronous cognitive telerehabilitation program aimed at enhancing the continuum of care for MCI SCCs and PD using technology The proposed study is a single blind randomized controlled trial RCT involving subjects with CNDs randomly assigned to one out of two intervention groups i the telecognitive group who will receive at-home cognitive telerehabilitation telecognitive treatment ii the active control group ACG who will receive at-home unstructured cognitive stimulation The aim of the project will be threefold 1 to test the short-term and long-term efficacy of telecognitive protocol as compared to an unstructured cognitive at-home rehabilitation in the treatment of a cohort of patients with CNDs 2 to explore the changes induced by telecognitive intervention on biomolecular and neurophysiological markers 3 to explore potential cognitive neurobiological and neurophysiological predictors of response to telecognitive treatment
Detailed Description:
60 subjects with MCI SCC PD will be recruited from IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli Brescia Fondazione Don Carlo Gnocchi - ONLUS Milan and IRCCS Centro Neurolesi Bonino Pulejo Messina
Patients will include both male and female subjects affected by CND PD Hoehn Yahr3 MCI with CDR scale05 MMSE 24 and SCC Subjective Cognitive Complaints
All patients will undergo 3 days a week for 5 weeks of treatment sessions of 45 minutes
30 subjects will be assigned to the telecognitive group that will receive home-based cognitive telerehabilitation activities with an innovative digital solution for remote rehabilitation of cognitive difficulties according to the digital therapy delivery model
30 subjects will be assigned to the active control group ACG that will receive home-based unstructured cognitive stimulation
The two groups will be matched for sex age education and performance in the MoCA test
All study participants will be administered a multidimensional assessment by an experienced neuropsychologist at baseline T0 at post-treatment assessment T1 5 weeks from T0 and at 3-month follow-up T2 In addition participation in the research involves blood sampling and application of transcranial magnetic stimulation TMS before T0 and after T1 treatment
Patients will include both male and female subjects affected by CND PD Hoehn Yahr3 MCI with CDR scale05 MMSE 24 and SCC Subjective Cognitive Complaints
All patients will undergo 3 days a week for 5 weeks of treatment sessions of 45 minutes
30 subjects will be assigned to the telecognitive group that will receive home-based cognitive telerehabilitation activities with an innovative digital solution for remote rehabilitation of cognitive difficulties according to the digital therapy delivery model
30 subjects will be assigned to the active control group ACG that will receive home-based unstructured cognitive stimulation
The two groups will be matched for sex age education and performance in the MoCA test
All study participants will be administered a multidimensional assessment by an experienced neuropsychologist at baseline T0 at post-treatment assessment T1 5 weeks from T0 and at 3-month follow-up T2 In addition participation in the research involves blood sampling and application of transcranial magnetic stimulation TMS before T0 and after T1 treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None