Boosting Reward-based Attention Through VEstibular STimulation

NCT ID: NCT03213119

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-23
• Study Completion Date: 2023-02-13

Brief Summary

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).

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Caloric Vestibular Stimulation, Left-Warm

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.

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

Caloric vestibular stimulation (CVS) involves the irrigation of cold or warm water into the external ear canal, and induces a temperature gradient across the semicircular canals stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function.

Caloric Vestibular Stimulation, Left-Cold

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.

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

Caloric vestibular stimulation (CVS) involves the irrigation of cold or warm water into the external ear canal, and induces a temperature gradient across the semicircular canals stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function.

Caloric Vestibular Stimulation, SHAM

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

Group Type: SHAM_COMPARATOR

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

Intervention Type: PROCEDURE

Caloric vestibular stimulation (CVS) involves the irrigation of cold or warm water into the external ear canal, and induces a temperature gradient across the semicircular canals stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function. The SHAM condition uses body-temperature water, and thus does not result into vestibular unbalance.

Interventions

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

Caloric vestibular stimulation (CVS) involves the irrigation of cold or warm water into the external ear canal, and induces a temperature gradient across the semicircular canals stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function.

Intervention Type: PROCEDURE

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

Caloric vestibular stimulation (CVS) involves the irrigation of cold or warm water into the external ear canal, and induces a temperature gradient across the semicircular canals stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function.

Intervention Type: PROCEDURE

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

Caloric vestibular stimulation (CVS) involves the irrigation of cold or warm water into the external ear canal, and induces a temperature gradient across the semicircular canals stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function. The SHAM condition uses body-temperature water, and thus does not result into vestibular unbalance.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CRNL, équipe IMPACT (CNRS UMR5292, INSERM U1028)

Bron, , France

Service de médecine et réadaptation neurologique, Hôpital Henry Gabrielle

Saint-Genis-Laval, , France

Countries

France

Other Identifiers

2017-A01784-49

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL17_0263

Identifier Type: -

Identifier Source: org_study_id