The medical device Mindlenses for cognitive rehabilitation in stroke
| ISRCTN | ISRCTN12243194 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12243194 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Fondazione Istituto G. Giglio di Cefalù |
| Funders | Restorative Neurotechnologies srl, EIT Health |
- Submission date
- 02/02/2024
- Registration date
- 07/02/2024
- Last edited
- 20/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Prism adaptation is a technique that involves wearing prismatic glasses to shift how a person sees the world. Studies have suggested that prism adaptation can change the activity of the brain hemisphere on the same side as the visual field change caused by the prisms. Stroke patients often experience changes in the activity of their brains on both the affected and unaffected sides. A necessary quality for a rehabilitation method is the ability to encourage changes in the activity of both sides of the brain in stroke patients with damage on one side. The aim of this study is to test the effectiveness of the medical device Mindlenses. Mindlenses combine prism adaptation with digital cognitive training through serious games to rehabilitate various cognitive functions in individuals who have had their first stroke.
Who can participate?
Patients aged 30-90 years with first-ever stroke
What does the study involve?
Patients are randomly assigned to an experimental group treated with Mindlenses or to a control group treated with standard rehabilitation. Patients wearing prismatic goggles are asked to make pointing movements towards visual stimuli presented on a tablet until adaptation to the visual distortion is reached. Immediately following this phase, the goggles are removed and the patients of the experimental group perform seven games on a tablet targeting attention, decision-making, planning and other cognitive functions.
What are the possible benefits and risks of participating?
There are no risks for participants. The expected benefits are an acceleration of improvement of cognitive abilities.
Where is the study run from?
Fondazione Istituto G. Giglio di Cefalù (Italy)
When is the study starting and how long is it expected to run for?
March 2019 to June 2022
Who is funding the study?
Restorative Neurotechnologies srl (Italy)
Who is the main contact?
Prof. Massimiliano Oliveri, massimiliano.oliveri@restorativeneurotechnologies.com
Contact information
Scientific
Via Trinacria 23
Palermo
90144
Italy
| Phone | +39 (0)3398857299 |
|---|---|
| massimiliano.oliveri@restorativeneurotechnologies.com |
Public, Principal investigator
Ospedale G Giglio
Cefalu
90015
Italy
| Phone | +39 (0)921 920111 |
|---|---|
| sergiobagnato@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional double-arm randomized non-inferiority study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Comparison of the efficacy of the combination of digital prism adaptation and serious games with standard rehabilitation for cognitive deficits in stroke patients |
| Study acronym | StrokeMind |
| Study objectives | The medical device Mindlenses is at least comparable to standard cognitive training for the rehabilitation of cognitive deficits in stroke patients. |
| Ethics approval(s) |
Approved 17/06/2019, Comitato Etico Palermo 1 (Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Via del Vespro, 129, Palermo, 90127, Italy; +39 (0)91 6551111; urp@policlinico.pa.it), ref: 06/2019 |
| Health condition(s) or problem(s) studied | Cognitive deficits in stroke |
| Intervention | Experimental treatment with the medical device Mindlenses, combining prism adaptation with serious games in 10 days. Control treatment with standard cognitive training Patients are randomly assigned by a simple randomization method to an experimental group treated with Mindlenses or to a control group treated with standard rehabilitation. Patients wearing prismatic goggles are asked to make pointing movements towards visual stimuli presented on a tablet until adaptation to the visual distortion is reached. Immediately following this phase, the goggles are removed and the patients of the experimental group perform seven games on a tablet targeting attention, decision-making, planning and other cognitive functions. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Mindlenses |
| Primary outcome measure(s) | All measured at baseline and immediately after the end of treatment: 1. General cognitive functioning will be measured using the Oxford Cognitive Screen 2. General intelligence and abstract thinking will be measured using the Ravens’ Progressive Matrices 3. Verbal short-term and working memory will be assessed using Digit Span Forward and Backward Tests 4. Spatial short-term and working memory will be assessed using Spatial Span Forward and Backward Tests 5. Verbal long-term memory will be assessed using the Rey Auditory Verbal Learning Test, Immediate and Delayed Recall 6. Constructional apraxia will be measured using the Rey Complex Figure Copy, the Freehand Copy of Drawings and The Copy of Drawings with Landmarks Tests 7. Attention will be measured using the Attentive Matrices and The Line Bisection Tests 8. Inhibition abilities will be measured using the Stroop Test 9. Language production abilities will be measured using the Name and Verb Naming Tests 10. Lexical semantic abilities will be measured using the Semantic Fluency Test 11. Visuospatial perception abilities will be measured using the Visual Object and Space Perception Battery (VOSP) 12. Buccofacial apraxia will be measured using the Buccofacial Apraxia Test Removed 13/06/2024: 13. Functional activities of daily living will be measured using the Barthel Index |
| Key secondary outcome measure(s) | All measured at baseline and immediately after the end of treatment: 1. Anxiety will be measured using the Beck Anxiety Inventory 2. Depression will be measured using the Hamilton Depression Scale Added 13/06/2024: 13. Functional activities of daily living will be measured using the Barthel Index |
| Completion date | 30/06/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 30 Years |
| Upper age limit | 90 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. First ever unilateral stroke 2. Aged 30-90 years |
| Key exclusion criteria | 1. Bilateral stroke 2. Other neurological disease |
| Date of first enrolment | 05/12/2019 |
| Date of final enrolment | 30/03/2022 |
Locations
Countries of recruitment
- Italy
Study participating centre
90015
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request. Not sensitive data concerning the clinical characteristics of the recruited patients could be available. Type of data: Excel files summarizing clinical and neuropsychological data of all tests at baseline and post-therapy sessions. Consent forms are required and obtained by the hospital that conducted the trial. The data sets could be requested from Prof. Massimiliano Oliveri (massimiliano.oliveri@restorativeneurotechnologies.com) or to Dr Agnese Di Garbo (agnese.digarborestorativeneurotechnologies.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 20/06/2024 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
Editorial Notes
20/06/2024: The basic results have been uploaded as an additional file.
13/06/2024: The following changes were made to the study record:
1. The study design was changed from 'Interventional double-arm randomized study' to 'Interventional double-arm randomized non-inferiority study'.
2.
02/02/2024: Study's existence confirmed by the Comitato Etico Palermo 1.
