Neurophysiological and Behavioral Study of the Cognitive Deficits Associated With Cerebral Small Vessel Disease in the SHIVA Cohort. SHIVA-CogNeurophys

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Home-based cognitive training

    Device

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Personalized cognitive training using an AI algorithmwith a non-linear learning path adapted to eachExperimental treatment 1 intervention
Group B: Traditional cognitive trainingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Day 0, Day 26, Day 33

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.