Telerehabilitation in Mild Cognitive Impairment

• Register: ClinicalTrials.gov
• Last refreshed on: 18 March 2024
• Main ID: NCT03486704
• Date of registration: 27/03/2018
• Prospective Registration: Yes
• Primary sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli
• Public title: Telerehabilitation in Mild Cognitive Impairment
• Scientific title: The Italian Network of Telerehabilitation: Evaluation of Telerehabilitation System in Mild Cognitive Impairment
• Date of first enrolment: April 9, 2018
• Target sample size: 109
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03486704
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Italy

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of MCI, defined according to standard criteria (Petersen et al., 2011)

- Mini Mental State Examination (MMSE) =24

- Education = 5 years

- All of the subjects will have normal or corrected-to-normal vision and will be native
Italian speakers.

- All participants reported subjective memory complaints and objective memory
impairment, but no impairment of function in daily life.

Exclusion Criteria:

- visual perception disorder and/or hearing loss

- history of major psychiatric disorders

- any contraindication for tDCS such as a history of seizures, major head trauma, past
brain surgery, a brain metal implant or a pacemaker.



Age minimum: 60 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Mild Cognitive Impairment

Intervention(s)

Behavioral: FTF VRRS plus unstructured CS

Behavioral: Usual rehabilitation program

Behavioral: Face to Face VRRS and telerehabilitation

Behavioral: Face to Face VRRS plus active tDCS and telerehabilitation

Behavioral: Face to Face VRRS plus placebo tDCS and telerehabilitation

Primary Outcome(s)

Change in long term episodic verbal memory [Time Frame: Baseline up to 12 weeks and 4 and 7 months]

Secondary Outcome(s)

Change in visual attention and task switching [Time Frame: Baseline up to 12 weeks and 4 and 7 months]

Change in dementia severity [Time Frame: Baseline up to 12 weeks and 4 and 7 months]

Change in memory complaints [Time Frame: Baseline up to 12 weeks and 4 and 7 months]

Change in verbal fluency [Time Frame: Baseline up to 12 weeks and 4 and 7 months]

Change in global cognition [Time Frame: Baseline up to 12 weeks and 4 and 7 months]

Change in nonverbal long term memory [Time Frame: Baseline up to 12 weeks and 4 and 7 months]

Change in naming abilities [Time Frame: Baseline up to 12 weeks and 4 and 7 months]

Change in measure of quality of life [Time Frame: Baseline up to 12 weeks and 4 and 7 months]

Change in non-verbal abstract reasoning [Time Frame: Baseline up to 12 weeks and 4 and 7 months]

Change in visual constructional abilities [Time Frame: Baseline up to 12 weeks and 4 and 7 months]

Secondary ID(s)

VR-Rehab-MCI

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

IRCCS Centro Neurolesi Bonino-Pulejo, Messina (IT)

IRCCS San Raffaele

Fondazione Don Carlo Gnocchi Onlus