Cerebral Small Vessel DiseaseSHIVA-CogNeuroNCT07068620
Neurophysiological and Behavioral Study of the Cognitive Deficits Associated With Cerebral Small Vessel Disease in the SHIVA Cohort. SHIVA-CogNeurophys
A study testing Home-based cognitive training in people with Cerebral Small Vessel Disease and Stroke, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Cerebral small vessel disease (cSVD) is characterized by an alteration of the structure and function of small penetrating brain arteries. Highly prevalent in older individuals from the general population, it represents a leading cause of stroke and a major contributor to cognitive decline and risk of dementia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Small Vessel Disease, Stroke, Cognitive Complaint
- What is being tested?
- Home-based cognitive training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 7 Aug 2025to 7 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients included or previously included in the SHIVA cohort
- Basic computer skills (ability to open a browser, use a mouse and keyboard)
- Access to a personal computer with an internet connection
- Independent in Activities of Daily Living (ADL) with a score ≥ 5/6, and in Instrumental Activities of Daily Living (IADL) with a score ≥ 4/8
- Informed and written consent signed by the participant and the investigating physician for this study
Who cannot join
- Motor impairments preventing the use of a keyboard and mouse (e.g., motor issues related to severe hand osteoarthritis)
- Depressive symptoms indicated by a score of 2 to 4 on the mini Geriatric Depression Scale (mini GDS), which includes 4 items
- Age-related macular degeneration (AMD)
- Untreated glaucoma
- Untreated psychiatric conditions that interfere with cognitive assessments
- Diagnosed attention deficit disorder with or without hyperactivity or patients who could not complete all cognitive tests required in the SHIVA cohort
Show all 21Show fewer
- Systemic diseases that cause cognitive changes, such as obesity and metabolic disorders
- History of epilepsy or seizures
- Scalp sensitivity or skin lesions (dermatitis, wounds, etc.)
- Contraindications for the use of electrical stimulation:
- Surgical clips, metal sutures, staples, stents
- Osteosynthesis material in the head or neck
- Pacemaker
- Implanted hearing aid
- Ocular foreign bodies, shrapnel, bullets
- Metalworker
- Pacemaker or neurostimulator
- Heart valve or endovascular material
- Ventricular shunt valve
- Recent exposure (< 6 months) to brain stimulation (tDCS, TMS, etc.)
- Ongoing participation in a clinical trial or cognitive training program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux, Hôpital Pellegrin, Unité Neurovasculaire
Bordeaux, 33000
IGOR SIBON, MD, PhD, 0556795313 ext. +33, igor.sibon@chu-bordeaux.fr
Jean-Sébastien LIEGEY, MD, 0557656325 ext. +33, jean-sebastien.liegey@chu-bordeaux.fr
About this study
Official title: Neurophysiological and Behavioral Study of the Cognitive Deficits Associated With Cerebral Small Vessel Disease in the SHIVA Cohort - SHIVA-CogNeurophys
Cerebral small vessel disease (cSVD) is characterized by an alteration of the structure and function of small penetrating brain arteries. Highly prevalent in older individuals from the general population, it represents a leading cause of stroke and a major contributor to cognitive decline and risk of dementia.
Better detection and management of covert cSVD would have a major impact on preventing disability and costs related to stroke, cognitive impairment and dementia. The aim of the present study is to identify novel electroencephalographic (EEG) biomarkers of the cognitive deficits associated with cSVD, and how these biomarkers and cognitive performance are affected by personalized cognitive training or transcranial alternating current stimulation (tACS), a non-invasvie brain stimulation technique.
Read the detailed description
cSVD is by far the most prevalent vascular contributor to cognitive impairment in the population. However, accurate quantitative estimates of the predictive ability of cSVD for risk of dementia are lacking. Moreover, stratification of cognitive decline and risk of dementia in cSVD patients according to imaging characteristics as well as evidence of coexisting neurodegenerative disease and vascular comorbidity are lacking. Moreover, there is currently no specific mechanism-based treatment, leading to empirical and heterogeneous clinical practice, which in most instances consists of ignoring these lesions. This clinical blind spot represents a major "missed opportunity" for the prevention of cognitive decline and dementia.
This study aims to explore the electroencephalographic (EEG) characteristics of patients with either extensive or minimal neurovascular lesions due to cSVD in 80 patients above 60 years old. The main goal is to identify EEG biomarkers that characterize these lesions and the associated cognitive deficits. Secondary objectives aim to assess the potential impact of cognitive training paradigms and non-invasive brain stimulation (namely transcranial alternating current stimulation - tACS) on these biomarkers and on cognitive performance.
Participants will be divided into two groups. The first group will consist of patients with no or minor white matter hyperintensities on brain MRI (i.e. features of minor cSVD) , while the second group will include patients with moderate to severe white matter hyperintensities (i.e., features of extensive cSVD).
This exploratory study leverages the uniqueness of the SHIVA cohort, a deeply characterized resource for investigation of cSVD. To our knowledge, the combination of EEG recordings, cognitive training, and noninvasive brain stimulation in cSVD patients is entirely novel
- Conditions
- Cerebral Small Vessel Disease, Stroke, Cognitive Complaint
- Being tested
- Home-based cognitive training
- Keywords
- Cognitive decline, dementia, stroke, small vessel disease, healthy brain aging, electroencephalography, neuromodulation, transcranial alternating current stimulation, cognitive training, cognitive rehabilitation
- Medical subject headings
- Cerebral Small Vessel Diseases, Stroke, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based cognitive trainingDevice
All interventions will be carried out for both groups of participants, with either minimal or extensive cSVD.
Upon enrollment, each participant will undergo two hospital visits (visit 1 at day 0, visit 2 at day 7), followed by a home-based cognitive training across 10 days (days 15-24), two more hospital visits (visit 3 at day 26, visit 4 at day 33), and finally a follow-up cognitive testing at home after 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Personalized cognitive training using an AI algorithmwith a non-linear learning path adapted to each | Experimental | Personalized cognitive training using an AI algorithm (zone of proximal development and empirical success - ZPDES - multi-arm algorithm), with a non-linear learning path adapted to each participant. Receives: Device: Home-based cognitive training |
| Traditional cognitive training | Active comparator | Traditional cognitive training using a "staircase" method, featuring a linear progression. Receives: Device: Home-based cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG signal power
The primary outcome measure is the average EEG signal power (across different frequency bands and for various electrodes) between the two participant groups with either minor or extensive cSVD
Measured: Day 0, Day 26, Day 33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start7 Aug 2025
- Primary completion7 Mar 2028 (estimated)
- Study completion7 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Small Vessel DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068620
- Sponsor's protocol ID
- CHUBX 2024-81
- Acronym
- SHIVA-CogNeuro
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological and Behavioral Study of the Cognitive Deficits Associated With Cerebral Small Vessel Disease in the SHIVA Cohort - SHIVA-CogNeurophys
- ClinicalTrials.gov ID
- NCT07068620
- Acronym / sponsor ID
- SHIVA-CogNeuro / CHUBX 2024-81
- Conditions
- Cerebral Small Vessel Disease, Stroke, Cognitive Complaint
- Keywords
- Cognitive decline, dementia, stroke, small vessel disease, healthy brain aging, electroencephalography, neuromodulation, transcranial alternating current stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 7 Mar 2028 (estimated)
- Study completion
- 7 Mar 2028 (estimated)
- First posted
- 16 Jul 2025 (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.
Cerebral small vessel disease (cSVD) is characterized by an alteration of the structure and function of small penetrating brain arteries. Highly prevalent in older individuals from the general population, it represents a leading cause of stroke and a major contributor to cognitive decline and risk of dementia.
Better detection and management of covert cSVD would have a major impact on preventing disability and costs related to stroke, cognitive impairment and dementia. The aim of the present study is to identify novel electroencephalographic (EEG) biomarkers of the cognitive deficits associated with cSVD, and how these biomarkers and cognitive performance are affected by personalized cognitive training or transcranial alternating current stimulation (tACS), a non-invasvie brain stimulation technique.
Detailed description
cSVD is by far the most prevalent vascular contributor to cognitive impairment in the population. However, accurate quantitative estimates of the predictive ability of cSVD for risk of dementia are lacking. Moreover, stratification of cognitive decline and risk of dementia in cSVD patients according to imaging characteristics as well as evidence of coexisting neurodegenerative disease and vascular comorbidity are lacking. Moreover, there is currently no specific mechanism-based treatment, leading to empirical and heterogeneous clinical practice, which in most instances consists of ignoring these lesions. This clinical blind spot represents a major "missed opportunity" for the prevention of cognitive decline and dementia.
This study aims to explore the electroencephalographic (EEG) characteristics of patients with either extensive or minimal neurovascular lesions due to cSVD in 80 patients above 60 years old. The main goal is to identify EEG biomarkers that characterize these lesions and the associated cognitive deficits. Secondary objectives aim to assess the potential impact of cognitive training paradigms and non-invasive brain stimulation (namely transcranial alternating current stimulation - tACS) on these biomarkers and on cognitive performance.
Participants will be divided into two groups. The first group will consist of patients with no or minor white matter hyperintensities on brain MRI (i.e. features of minor cSVD) , while the second group will include patients with moderate to severe white matter hyperintensities (i.e., features of extensive cSVD).
This exploratory study leverages the uniqueness of the SHIVA cohort, a deeply characterized resource for investigation of cSVD. To our knowledge, the combination of EEG recordings, cognitive training, and noninvasive brain stimulation in cSVD patients is entirely novel
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized cognitive training using an AI algorithmwith a non-linear learning path adapted to each | Experimental | Device: Home-based cognitive trainingPersonalized cognitive training using an AI algorithm (zone of proximal development and empirical success - ZPDES - multi-arm algorithm), with a non-linear learning path adapted to each participant. |
| Traditional cognitive training | Active comparator | Device: Home-based cognitive trainingTraditional cognitive training using a "staircase" method, featuring a linear progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients included or previously included in the SHIVA cohort
- Basic computer skills (ability to open a browser, use a mouse and keyboard)
- Access to a personal computer with an internet connection
- Independent in Activities of Daily Living (ADL) with a score ≥ 5/6, and in Instrumental Activities of Daily Living (IADL) with a score ≥ 4/8
- Informed and written consent signed by the participant and the investigating physician for this study
Key exclusion criteria (21 listed)
- Motor impairments preventing the use of a keyboard and mouse (e.g., motor issues related to severe hand osteoarthritis)
- Depressive symptoms indicated by a score of 2 to 4 on the mini Geriatric Depression Scale (mini GDS), which includes 4 items
- Age-related macular degeneration (AMD)
- Untreated glaucoma
- Untreated psychiatric conditions that interfere with cognitive assessments
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 |
|---|---|---|
| Home-based cognitive trainingAll interventions will be carried out for both groups of participants, with either minimal or extensive cSVD. Upon enrollment, each participant will undergo two hospital visits (visit 1 at day 0, visit 2 at day 7), followed by a home-based cognitive training across 10 days (days 15-24), two more hospital visits (visit 3 at day 26, visit 4 at day 33), and finally a follow-up cognitive testing at home after 6 months. | Device | Personalized cognitive training using an AI algorithmwith a non-linear learning path adapted to each, Traditional cognitive training |
Primary outcome
EEG signal power
Time frame: Day 0, Day 26, Day 33
The primary outcome measure is the average EEG signal power (across different frequency bands and for various electrodes) between the two participant groups with either minor or extensive cSVD
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based cognitive training in people with Cerebral Small Vessel Disease and Stroke, run by University Hospital, Bordeaux at 1 site in France.
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 21 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: looking for participants now, as of the sponsor's last update on 2 Feb 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IGOR SIBON, MD, PhD (0556795313 ext. +33, igor.sibon@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG signal power (time frame: Day 0, Day 26, Day 33). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2026.