Mild Cognitive ImpairmentNCT03486704
Telerehabilitation in Mild Cognitive Impairment
A study testing Face to Face VRRS and telerehabilitation, Usual rehabilitation program and FTF VRRS plus unstructured CS in people with Mild Cognitive Impairment, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
Trial summary
The main aim of the study is to evaluate the efficacy of the Virtual Reality Rehabilitation System (VRRS) compared to usual care treatment for patients with Mild Cognitive Impairment (MCI). Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Face to Face VRRS and telerehabilitation, Usual rehabilitation program and FTF VRRS plus unstructured CS
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteItaly
- Study dates
- 9 Apr 2018to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Italian Network of Telerehabilitation: Evaluation of Telerehabilitation System in Mild Cognitive Impairment
The main aim of the study is to evaluate the efficacy of the Virtual Reality Rehabilitation System (VRRS) compared to usual care treatment for patients with Mild Cognitive Impairment (MCI). Moreover, we will assess the possibility to prolong the beneficial effects of the treatment with an innovative telerehabilitation system. In the second phase of the present study we aim to evaluate the short and long term effects induced by the treatment of active (anodal) transcranial Direct Current Stimulation (tDCS) applied to the left dorsolateral prefrontal cortex combined with VRRS compared to placebo tDCS stimulation combined with VRRS.
The effects of the intervention on outcome variables will be assessed using a randomized controlled trial design with five groups. The investigators will assess the effects of VRRS system and of the implementation of the at-home treatment on the quality of life, cognitive and functional abilities.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Face to Face VRRS and telerehabilitation, Usual rehabilitation program, FTF VRRS plus unstructured CS, Face to Face VRRS plus active tDCS and telerehabilitation, Face to Face VRRS plus placebo tDCS and telerehabilitation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face to Face VRRS and telerehabilitationBehavioural
Face to Face cognitive training using VRRS plus telerehabilitation. Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week.
Cognitive training will initially be tailored to the patient's baseline characteristics. The exercise program will be charged by therapist on the patient's computer before the beginning of the at-home treatment. Each patient's performed session will be reviewed by the therapist.
The group will receive a kit home-based (a tablet home, access to a daily individualized cognitive training program).
Usual rehabilitation programBehavioural
The usual rehabilitation group will receive 12 sessions of face-to-face usual cognitive training program.
FTF VRRS plus unstructured CSBehavioural
Face to Face cognitive training using VRRS plus at-home unstructured cognitive stimulation.
Participants will receive 12 sessions of an individualized Face to Face (FTF) cognitive training using VRRS over 4 weeks followed by 36 sessions of home-based unstructured cognitive stimulation (CS), three sessions for week.
Face to Face VRRS plus active tDCS and telerehabilitationBehavioural
Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week.
Face to Face VRRS cognitive training will initially be tailored to the patient's baseline characteristics.
The exercise program will be charged by therapist on the patient's computer before the beginning of the at-home treatment. Each patient's performed session will be reviewed by the therapist.The group will receive a kit home-based (a tablet home, access to a daily individualized cognitive training program).
Face to Face VRRS plus placebo tDCS and telerehabilitationBehavioural
Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS combined with placebo tDCS applied to the dorsolateral prefrontal cortex of the left hemisphere over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week.
Face to Face VRRS cognitive training will initially be tailored to the patient's baseline characteristics.
The exercise program will be charged by therapist on the patient's computer before the beginning of the at-home treatment. Each patient's performed session will be reviewed by the therapist.The group will receive a kit home-based (a tablet home, access to a daily individualized cognitive training program).
| Study group | Role | What they receive |
|---|---|---|
| Face to Face VRRS and telerehabilitation | Experimental | Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week. Receives: Behavioral: Face to Face VRRS and telerehabilitation |
| Usual rehabilitation program | Active comparator | The usual rehabilitation group will receive 12 sessions of face-to-face usual cognitive training program. Receives: Behavioral: Usual rehabilitation program |
| FTF VRRS plus unstructured CS | Active comparator | Participants will receive 12 sessions of an individualized Face to Face (FTF) cognitive training using VRRS over 4 weeks followed by 36 sessions of home-based unstructured cognitive stimulation (CS), three sessions for week. Receives: Behavioral: FTF VRRS plus unstructured CS |
| Face to Face VRRS plus active tDCS and telerehabilitation | Experimental | Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week. Receives: Behavioral: Face to Face VRRS plus active tDCS and telerehabilitation |
| Face to Face VRRS plus placebo tDCS and telerehabilitation | Active comparator | Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS combined with placebo tDCS applied to the dorsolateral prefrontal cortex of the left hemisphere over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week. Receives: Behavioral: Face to Face VRRS plus placebo tDCS and telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in long term episodic verbal memory
Free and Cued Selective Reminding Test (FCSRT)
Measured: Baseline up to 12 weeks and 4 and 7 months
Change in long term episodic verbal memory
Auditory Verbal Learning Test, immediate and delayed recall
Measured: Baseline up to 12 weeks and 4 and 7 months
Secondary outcomes (10)
Change in measure of quality of life
Quality of Life in Alzheimer's Disease (AD) - QoL-AD
Measured: Baseline up to 12 weeks and 4 and 7 months
Change in dementia severity
Clinical Dementia Rating scale (CDR)
Measured: Baseline up to 12 weeks and 4 and 7 months
Change in global cognition
Mini Mental State Examination (MMSE)
Measured: Baseline up to 12 weeks and 4 and 7 months
Change in memory complaints
Everyday Memory Questionnaire (EMQ)
Measured: Baseline up to 12 weeks and 4 and 7 months
Change in visual constructional abilities
Rey-Osterrieth Figure Copy
Measured: Baseline up to 12 weeks and 4 and 7 months
Change in nonverbal long term memory
Rey-Osterrieth Figure Recall
Measured: Baseline up to 12 weeks and 4 and 7 months
Change in visual attention and task switching
Trail Making Test
Measured: Baseline up to 12 weeks and 4 and 7 months
Change in naming abilities
Object and action naming subtests of the Battery for the Analysis of the Aphasic Deficit
Measured: Baseline up to 12 weeks and 4 and 7 months
Change in non-verbal abstract reasoning
Raven's Colored Progressive Matrices
Measured: Baseline up to 12 weeks and 4 and 7 months
Change in verbal fluency
Phonemic verbal fluency and semantic verbal fluency
Measured: Baseline up to 12 weeks and 4 and 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start9 Apr 2018
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Centro Neurolesi Bonino Pulejo, Fondazione Don Carlo Gnocchi ETS, IRCCS San Raffaele
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486704
- Sponsor's protocol ID
- VR-Rehab-MCI
- Status last verified
- Mar 2024
- First submitted
- 27 Mar 2018
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Manenti R, Baglio F, Pagnoni I, Gobbi E, Campana E, Alaimo C, Rossetto F, Di Tella S, Pagliari C, Geviti A, Bonfiglio NS, Calabro RS, Cimino V, Binetti G, Quartarone A, Bramanti P, Cappa SF, Rossini PM, Cotelli M. Long-lasting improvements in episodic memory among subjects with mild cognitive impairment who received transcranial direct current stimulation combined with cognitive treatment and telerehabilitation: a multicentre, randomized, active-controlled study. Front Aging Neurosci. 2024 Jun 18;16:1414593. doi: 10.3389/fnagi.2024.1414593. eCollection 2024.
PubMed 38966802Manenti R, Gobbi E, Baglio F, Macis A, Ferrari C, Pagnoni I, Rossetto F, Di Tella S, Alemanno F, Cimino V, Binetti G, Iannaccone S, Bramanti P, Cappa SF, Cotelli M. Effectiveness of an Innovative Cognitive Treatment and Telerehabilitation on Subjects With Mild Cognitive Impairment: A Multicenter, Randomized, Active-Controlled Study. Front Aging Neurosci. 2020 Nov 16;12:585988. doi: 10.3389/fnagi.2020.585988. eCollection 2020.
PubMed 33304267
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Italian Network of Telerehabilitation: Evaluation of Telerehabilitation System in Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03486704
- Acronym / sponsor ID
- VR-Rehab-MCI
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
- Collaborators
- IRCCS Centro Neurolesi Bonino Pulejo, Fondazione Don Carlo Gnocchi ETS, IRCCS San Raffaele
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 3 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of the study is to evaluate the efficacy of the Virtual Reality Rehabilitation System (VRRS) compared to usual care treatment for patients with Mild Cognitive Impairment (MCI). Moreover, we will assess the possibility to prolong the beneficial effects of the treatment with an innovative telerehabilitation system. In the second phase of the present study we aim to evaluate the short and long term effects induced by the treatment of active (anodal) transcranial Direct Current Stimulation (tDCS) applied to the left dorsolateral prefrontal cortex combined with VRRS compared to placebo tDCS stimulation combined with VRRS.
The effects of the intervention on outcome variables will be assessed using a randomized controlled trial design with five groups. The investigators will assess the effects of VRRS system and of the implementation of the at-home treatment on the quality of life, cognitive and functional abilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Face to Face VRRS and telerehabilitation | Experimental | Behavioral: Face to Face VRRS and telerehabilitationParticipants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week. |
| Usual rehabilitation program | Active comparator | Behavioral: Usual rehabilitation programThe usual rehabilitation group will receive 12 sessions of face-to-face usual cognitive training program. |
| FTF VRRS plus unstructured CS | Active comparator | Behavioral: FTF VRRS plus unstructured CSParticipants will receive 12 sessions of an individualized Face to Face (FTF) cognitive training using VRRS over 4 weeks followed by 36 sessions of home-based unstructured cognitive stimulation (CS), three sessions for week. |
| Face to Face VRRS plus active tDCS and telerehabilitation | Experimental | Behavioral: Face to Face VRRS plus active tDCS and telerehabilitationParticipants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week. |
| Face to Face VRRS plus placebo tDCS and telerehabilitation | Active comparator | Behavioral: Face to Face VRRS plus placebo tDCS and telerehabilitationParticipants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS combined with placebo tDCS applied to the dorsolateral prefrontal cortex of the left hemisphere over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face to Face VRRS and telerehabilitationFace to Face cognitive training using VRRS plus telerehabilitation. Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week. Cognitive training will initially be tailored to the patient's baseline characteristics. The exercise program will be charged by therapist on the patient's computer before the beginning of the at-home treatment. Each patient's performed session will be reviewed by the therapist. The group will receive a kit home-based (a tablet home, access to a daily individualized cognitive training program). | Behavioural | Face to Face VRRS and telerehabilitation |
| Usual rehabilitation programThe usual rehabilitation group will receive 12 sessions of face-to-face usual cognitive training program. | Behavioural | Usual rehabilitation program |
| FTF VRRS plus unstructured CSFace to Face cognitive training using VRRS plus at-home unstructured cognitive stimulation. Participants will receive 12 sessions of an individualized Face to Face (FTF) cognitive training using VRRS over 4 weeks followed by 36 sessions of home-based unstructured cognitive stimulation (CS), three sessions for week. | Behavioural | FTF VRRS plus unstructured CS |
| Face to Face VRRS plus active tDCS and telerehabilitationParticipants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week. Face to Face VRRS cognitive training will initially be tailored to the patient's baseline characteristics. The exercise program will be charged by therapist on the patient's computer before the beginning of the at-home treatment. Each patient's performed session will be reviewed by the therapist.The group will receive a kit home-based (a tablet home, access to a daily individualized cognitive training program). | Behavioural | Face to Face VRRS plus active tDCS and telerehabilitation |
| Face to Face VRRS plus placebo tDCS and telerehabilitationParticipants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS combined with placebo tDCS applied to the dorsolateral prefrontal cortex of the left hemisphere over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week. Face to Face VRRS cognitive training will initially be tailored to the patient's baseline characteristics. The exercise program will be charged by therapist on the patient's computer before the beginning of the at-home treatment. Each patient's performed session will be reviewed by the therapist.The group will receive a kit home-based (a tablet home, access to a daily individualized cognitive training program). | Behavioural | Face to Face VRRS plus placebo tDCS and telerehabilitation |
Primary outcome
Change in long term episodic verbal memory
Time frame: Baseline up to 12 weeks and 4 and 7 months
Free and Cued Selective Reminding Test (FCSRT)
Change in long term episodic verbal memory
Time frame: Baseline up to 12 weeks and 4 and 7 months
Auditory Verbal Learning Test, immediate and delayed recall
10 secondary outcomes
Change in measure of quality of life
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 global cognition
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 visual constructional abilities
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 visual attention and task switching
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 non-verbal abstract reasoning
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Derived from this study: PubMed 38966802Manenti R, Baglio F, Pagnoni I, Gobbi E, Campana E, Alaimo C, Rossetto F, Di Tella S, Pagliari C, Geviti A, Bonfiglio NS, Calabro RS, Cimino V, Binetti G, Quartarone A, Bramanti P, Cappa SF, Rossini PM, Cotelli M. Long-lasting improvements in episodic memory among subjects with mild cognitive impairment who received transcranial direct current stimulation combined with cognitive treatment and telerehabilitation: a multicentre, randomized, active-controlled study. Front Aging Neurosci. 2024 Jun 18;16:1414593. doi: 10.3389/fnagi.2024.1414593. eCollection 2024.
- Derived from this study: PubMed 33304267Manenti R, Gobbi E, Baglio F, Macis A, Ferrari C, Pagnoni I, Rossetto F, Di Tella S, Alemanno F, Cimino V, Binetti G, Iannaccone S, Bramanti P, Cappa SF, Cotelli M. Effectiveness of an Innovative Cognitive Treatment and Telerehabilitation on Subjects With Mild Cognitive Impairment: A Multicenter, Randomized, Active-Controlled Study. Front Aging Neurosci. 2020 Nov 16;12:585988. doi: 10.3389/fnagi.2020.585988. eCollection 2020.
- Individual participant dataSharing planned: No
Related trials for Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face to Face VRRS and telerehabilitation, Usual rehabilitation program and FTF VRRS plus unstructured CS in people with Mild Cognitive Impairment, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in long term episodic verbal memory (time frame: Baseline up to 12 weeks and 4 and 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03486704, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.