Brain Lesion of the Right Hemisphere Clinical Trial
— BRAVESTOfficial title:
Boosting Reward-based Attention Through VEstibular STimulation
| Verified date | February 2023 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The exploration of space is more effective when intrinsically rewarding elements are located in the visual scene. Thus, rewards could be exploited as a novel rehabilitation approach to various attentional disorders. The first part of the project aims to characterize these effects at the behavioural level. The interventional part consists then in the administration of Caloric Vestibular Stimulation (CVS), which by means of injection of a small quantity of water in the external ear activates the vestibular organs and subsequently vestibular-related brain areas. Among the observed brain activations, the possibility to reach cingulate areas appears particularly interesting because it foreshadows the possibility to further enhance attentional capture by rewards. CVS will be delivered to patients with brain lesion of the right hemisphere, engaged in cancellation tasks requiring the processing of targets of different nature (e.g. monetary or neutral). The main prediction is that CVS administration would enhance spatial exploration in terms of center of gravity of the cancellation and improved accuracy as a function of the type of target processed (e.g. its value).
| Status | Suspended |
| Enrollment | 60 |
| Est. completion date | February 13, 2023 |
| Est. primary completion date | May 8, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility | Inclusion Criteria: - More than 18 years of age, less than 85 - right handed - Benefit of social health security - Normal or corrected-to-normal vision - Brain lesion localised in the right hemisphere, confirmed by CT or MRI Exclusion Criteria: - Anamnesis of neurological of psychiatric illness - Pregnancy or breastfeeding - Administrative measures restricting legal rights - Recent participation to other brain stimulation studies (< 1 week) - Perforation of the tympanic membrane - Anamnesis of recurrent otitis media |
| Country | Name | City | State |
|---|---|---|---|
| France | CRNL, équipe IMPACT (CNRS UMR5292, INSERM U1028) | Bron | |
| France | Service de médecine et réadaptation neurologique, Hôpital Henry Gabrielle | Saint-Genis-Laval |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Center of Gravity (pixels). | For line bisection defined as the difference between participants' mark and the objective center of the line. For cancellation tasks it is calculated as the grand average of horizontal and vertical coordinates of all the marks. In both cases smaller indices indicate a leftward exploration bias, whereas larger indices indicate rightward bias. | Days 1, 2, and 3 | |
| Secondary | Reaction times (ms). | The speed of response is a traditional indicator of the amount of cognitive processing underneath provided responses. It is measured by professional programs (e.g. Presentation) running on standard PCs | Days 1, 2, and 3. | |
| Secondary | Response accuracy (%) | The proportion of correct responses provided, automatically computed by professional programs (e.g. Presentation) running on standard PCs. | Days 1, 2, and 3. |