Boosting Reward-based Attention Through VEstibular STimulation (BRAVEST)

Civil Hospices of Lyon

Status: Suspended

Conditions: Unilateral Spatial Neglect for Half of Them; Brain Lesion of the Right Hemisphere

Treatments: Procedure: Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.

Study type: Interventional

Funder types: Other

Identifiers

NCT03213119

69HCL17_0263

2017-A01784-49 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Caloric Vestibular Stimulation, Left-Warm

Experimental group

Description:

Caloric Vestibular Stimulation (CVS) stimulates the vestibular system through thermic currents applied through small quantity of water injected in the external ear. The Left-Warm condition uses water with a temperature of 44°. It induces a nystagmus with its slow phase towards the right.

Treatment:

Procedure: Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.

Procedure: Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.

Procedure: Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.

Caloric Vestibular Stimulation, Left-Cold

Experimental group

Description:

Caloric Vestibular Stimulation (CVS) stimulates the vestibular system through thermic currents applied through small quantity of water injected in the external ear. The Left-Cold condition uses water with a temperature of 30°. It induces a nystagmus with its slow phase towards the left.

Treatment:

Procedure: Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.

Procedure: Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.

Procedure: Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.

Caloric Vestibular Stimulation, SHAM

Sham Comparator group

Description:

The SHAM condition uses water with a temperature of 37°. It does not induce nystagmus

Treatment:

Procedure: Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.

Procedure: Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.

Procedure: Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.