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Neuroma, Acoustic clinical trials

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NCT ID: NCT03958006 Completed - Clinical trials for Vestibular Schwannoma

Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

Start date: December 5, 2018
Phase: N/A
Study type: Interventional

This study will address the feasibility of simultaneous cochlear implantation during resection of a vestibular schwannoma.

NCT ID: NCT03795675 Recruiting - Clinical trials for Vestibular Schwannoma

CI Following VS Removal or Labyrinthectomy

Start date: January 14, 2019
Phase: N/A
Study type: Interventional

This study is a prospective, clinical study to determine if it is safe and effective to use a cochlear implant over time in individuals undergoing removal of a vestibular schwannoma (VS), benign tumor of the hearing and balance nerve or undergoing a labyrinthectomy for treatment of Meniere's disease. Individuals undergoing these surgeries will be deaf on the surgical side after the procedure. Currently, cochlear implants are approved for use and not considered investigational in individuals with hearing loss on both sides. However, use of a cochlear implant for these patient populations (single-sided hearing loss) will be considered a new use of an approved device. Participants undergoing surgery to remove a VS or having a labyrinthectomy will have a cochlear implant inserted after the surgical procedure for clinical care. Approximately 4 weeks after surgery, participants will be fitted with an external speech processor on the surgical side that will stimulate the internal cochlear implant. Participants will return at the following intervals after the initial processor fitting: 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months. At each interval, participants will complete questionnaires on how they are hearing with the implant and their quality of life with the implant and be tested on their ability to hear sounds and understand speech. Potential risks are those associated with all cochlear implant surgeries, and include device failure resulting in removal of device, irritation or redness in surgical area and/or area where processor is attached, increased ringing in the ear, facial nerve stimulation and a change in the way speech and other sounds sound through the implant. Potential benefits to individual participants in this study include improvement in detection and speech understanding of the surgical ear. Participants may also experience improved abilities to locate sound and understand speech in noise as the result of having hearing on both sides.

NCT ID: NCT03745560 Recruiting - Hearing Loss Clinical Trials

Intraoperative EABR for Decision Making

Start date: May 23, 2017
Phase:
Study type: Observational

In this study patients undergoing simultaneous translabyrinthine vestibular schwannoma resection and cochlear implantation are included. The goal of the study is to correlate the eABR results with postoperative hearing results.

NCT ID: NCT03745534 Recruiting - Hearing Loss Clinical Trials

Cochlear Implantation After Gamma Knife Radiosurgery With eABR and Correlation to Postoperative Hearing Results - a Pilot Study

Start date: August 1, 2018
Phase:
Study type: Observational

Patients undergoing cochlear implantation after radio surgery for vestibular schwannoma will be included in the study. Patients will undergo preoperative and intraoperative eABR measurement. Correlations to postoperative hearing results will be drawn.

NCT ID: NCT03670589 Completed - Dizziness Clinical Trials

Vestibular Evaluation After Vestibular Schwannoma Treatment

EVTSVCGEC
Start date: June 28, 2018
Phase:
Study type: Observational

Vestibular schwannoma is a benign tumor located on the vestibular nerve. Patient could present dizziness symptoms cause to the tumor, and at least after the treatment by gamaknife radiosurgery or microsurgery resection. Only few studies keep the interest about dizziness symptoms and treatment modality in vestibular schwannoma. In the study dizziness symptoms were compared before and after the treatment of vestibular schwannoma by radiosurgery gammaknife or microsurgery resection. 2 scales were used : dizziness handicap inventory (DHI) and dizziness functionnal scale (AAO).

NCT ID: NCT03666507 Completed - Clinical trials for Vestibular Schwannoma

Vegetative Monitoring During Brainstem-associated Surgery

Start date: August 28, 2018
Phase:
Study type: Observational

Intraoperative Monitoring of Heart rate variability, Blood pressure variability, Baroreceptorsensivity etc.

NCT ID: NCT03638310 Completed - Clinical trials for Vestibular Schwannoma

Role of Psychiatric Profile in Prehabituated Patients After Vestibular Schwannoma Surgery

Start date: January 1, 2016
Phase: N/A
Study type: Interventional

The aim of this study is to assess effect of psychiatric profile on visual sensitivity and overall health status in patients who underwent surgery for vestibular schwannoma and were prehabituated by chemical vestibular ablation.

NCT ID: NCT03593577 Recruiting - Clinical trials for Vestibular Schwannoma

Secondary Endolymphatic Hydrops and Vestibular Schwannomas on 3 Tesla MRI

Start date: June 1, 2018
Phase:
Study type: Observational

Endolymphatic hydrops is well known of the lay public in its primary form that is Ménière disease. Nowadays, the best w ay to approach it in vivo, is to use magnetic resonance imaging (MRI). However, endolymphatic hydrops don't limit itself to its primary form but cover a whole range of pathologies. The hypothesis is that patients with vestibular schwannomas are more likely to develop secondary saccular hydrops. The aim is to compare high-resolution T2-weighted images of the saccule in patients followed up for vestibular schwannomas with healthy volunteers and histological sections from cadavers in order to identify its changes. The secondary purpose of The protocol is to determine if vestibular and audiometric abnormalities could be related to this secondary hydrops more specifically than to the tumor size and localisation.

NCT ID: NCT03581331 Completed - Visual Impairment Clinical Trials

Consequence of Unilateral Vestibular Loss on Visual Abilities

SVorthoptie
Start date: February 26, 2018
Phase: N/A
Study type: Interventional

Unilateral vestibular lesions are frequent and disabling pathologies causing a set of oculomotor, postural and perceptual symptoms. These symptoms reduce over time according to a vestibular compensation. However, vestibular compensation should be considered as a set of sub-processes whose duration and recovery level differ. Indeed, after a unilateral vestibular loss, some functions remain asymmetrical as a long-term effect, and these disorders may be observed among patients with no functional complaints. Balance disorders may persist in some patients. The equilibration consists in handling real-time a considerable amount of information coming from the environment and the subject himself, allowing an adaptation of the position and movements of his body to satisfy the needs of posture, balance and orientation. This information comes mainly from the vision, the vestibule and the somesthesic system. It is pre-treated and harmonized in the brainstem, before being transmitted to the higher brain centres. Brain centers thus learn about peripheral conditions. According to these and the project of the movement, brain centers address in response orders to ophtalmological and motor effectors ensuring look, posture and balance to be provided. The eye is a cornerstone of the balancing system through the retina, an environmental sensor, and its extraocular muscles, effectors of the system. The aim of this study is to assess the effects of acute unilateral vestibular loss on visual abilities evaluated by orthoptic balance in patients who presented acute unilateral vestibular loss by surgical deafferentation (removal of vestibular schwannoma, vestibular neurotomy or surgical labyrinthectomy for Meniere's disease), during the early phase and decline of vestibular compensation. Our secondary objective is to evaluate the effect of a pre-existing anomaly of the visual abilities evaluated by orthoptic assessment on the vestibular compensation capacities. All in all, this study seems crucial to improve the management of patients with unilateral vestibular dysfunction and contribute to improving their clinical management. As a standardized management of these patients, an audio-vestibular evaluation will be performed before surgery (-1D), after acute unilateral vestibular loss at the early stage (+7D), and then after vestibular compensation (+2M) as well as an orthoptic evaluation. A good tolerance of the orthoptic evaluation is expected in this surgical context.

NCT ID: NCT03569943 Withdrawn - Clinical trials for Patient Operated on From a Vestibular Schwannoma With a Middle Ear Exclusion

Robot Based Tympanic Tube Placement

ROBOTOL
Start date: January 3, 2019
Phase: N/A
Study type: Interventional

Middle ear surgery is performed in a deep workspace through a narrow approach to the tympanic cavity, either by the external auditory canal, or by drilling the temporal bone. It uses thin and long instruments as a delicate and precise gesture on the ossicular chain or manipulation of very light prostheses is necessary. The results of middle ear procedures relies upon the surgeon experience and his gesture accuracy. For this reason, a robot-based device designed to assist the surgeon during middle ear procedure has been build. The goal of the present protocol is to evaluate the robot in a simple procedure to ensure its safety before using the device in more complex cases. The precision of the robot during transtympanic tube placement will be evaluated. The following benefits are expected: - Significantly reduced risk of transtympanic tube on the other side of the eardrum. - Positioning of the transtympanic tube in the desired tympanic quadrant - Reduces the size of the entry point to prevent tearing - Reduced risk of injury to the external auditory canal Once the safety of use of the robot is demonstrated in this protocol, the goal will be to evaluate it later in more complex surgical gestures in other protocols. The future application of the robot will be the placement of middle ear implant prosthesis in the context of the surgery for cholesteatoma, otosclerosis or insertion of cochlear implants.