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Neuroma, Acoustic clinical trials

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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: 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: NCT03520829 Recruiting - Brain Metastases Clinical Trials

Protocol for Evaluating a Planning Algorithm for Gamma Knife Radiosurgery

SPEED
Start date: January 10, 2018
Phase:
Study type: Observational

The process of developing Gamma Knife radiosurgery treatment plans is today very dependent on the level of human expertise resulting in a great heterogeneity of the intrinsic qualities of the treatment planning and the quality of care delivered in radiosurgery. The existing reverse planning systems, although they have progressed considerably in recent years, produce results that are still lower than those achieved by an expert. Conventionally, an experienced dosimetric planner will act mainly on the coordinates of the position of the isocenters, on the size of the collimators, sector by sector, and on the irradiation time of each isocenters. In theory, the combination of these variables provides access to billions of combinatorics whose diversity far exceeds the computational capabilities of the human mind. The dosimetric planner therefore uses a very small part of the spectrum of possible patterns by always reproducing a limited number of empirical solutions. The company Intuitive Therapeutics has developed a new mathematical algorithm which can automatically test in a very short time all the combinatorial possibilities and converge very quickly to the solution that best meets the clinical, anatomical and dosimetric objectives defined by the neurosurgeon. The quick processing of the system also allows the operator to modify the constraints to refine the proposed result in real time. The demonstration of the reality of the performances of this algorithm would give the ability to even inexperienced users to develop high performance planning for the benefit of the patient in terms of optimizing the efficacy / toxicity ratio of the radiosurgery treatment results The primary objective is to evaluate comparatively the quality of the schedules produced by the algorithm developed by the company Innovative Therapeutics to those produced by an expert who carried out more than 15000 dosimetric plannings and radiosurgical interventions. The main criterion of comparison is the Paddick index. The secondary criteria for comparison are: - Compliance index - selectivity index - Gradient index - Maximum, minimum, average dose at risk structures - Dose distribution in the target volume - Treatment time (at equal source activity) - Time of realization of the planning It was chosen to treat patients with vestibular Schwannoma OR multiple brain metastases (> 5) treated in single session by Gamma Knife OR para-optic meningioma in hypo-fractionated treatment on Gamma Knife with restraint mask with inclusion of visual paths in the target volume planning. The aim of the study is to show at least the non-inferiority of this new method compared to the expert user based on the Paddick Index. This index has continuous values between 0 and 1, 0 being the worst case and 1 being the ideal solution. In order to define the sample size needed for each pathology, a pilot phase is required. This phase can be performed retrospectively using treatments already defined by the expert user. This pilot phase will allow us to identify the difference that can be expected between the index values and the variability of this difference. Based on these values we will be able to determine the size of the sample allowing us to statistically test the non-inferiority, or even the superiority of this new device. The number of cases to be included during the pilot phase should be at least ten cases and a maximum of thirty cases. The choice of the number of cases to be integrated during this pilot phase will depend on the homogeneity of the differences obtained on the first cases. These values will allow us to calculate the size of the samples necessary for the study of non-inferiority as well as for the study of superiority. Depending on the calculated sizes samples we will make a choice to ensure that this study takes place in the expected duration.

NCT ID: NCT03393689 Recruiting - Acoustic Neuroma Clinical Trials

RGD PET/MRI in Sporadic Vestibular Schwannoma

Start date: January 2, 2018
Phase: Phase 2
Study type: Interventional

The aim of this non-randomised, prospective study is to investigate the applicability and prognostic value of angiogenesis PET/MR with the radioligand 68Ga-NODAGA- E[c(RGDyK)]2 in patients with sporadic Vestibuarl Schwannomas.

NCT ID: NCT03079999 Recruiting - Clinical trials for Vestibular Schwannoma

Study of Aspirin in Patients With Vestibular Schwannoma

Start date: June 11, 2018
Phase: Phase 2
Study type: Interventional

This is a phase II prospective, randomized, double-blind, longitudinal study evaluating whether the administration of aspirin can delay or slow tumor growth and maintain or improve hearing in VS patients.

NCT ID: NCT02275325 Recruiting - Clinical trials for Vestibular Schwannoma

Preoperative Vestibular Rehabilitation Effectiveness After Vestibular Schwannoma Surgery

ReveSTAN
Start date: January 2015
Phase: N/A
Study type: Interventional

Vestibular schwannoma (VS) is a benign tumour from Schwann cells surrounding the vestibular nerve, which slowly grows within the internal auditory canal and then into the cerebellopontine angle, leading to a gradual vestibular dysfunction. The slowly progressive alteration of vestibular function allows the gradual implementation of central adaptive mechanisms called vestibular compensation. The total unilateral vestibular deafferentation induced by the surgical tumour removal suddenly leads to a decompensation of this previously compensated situation, which explains why most patients report severe vertigo immediately after surgery and which is responsible for perturbations of the postural control (Parietti-Winkler et al., 2006, 2008, 2010, 2011). Recently, Gauchard et al. (2013) suggested that preoperative and regular physical activity would limit the adverse effects of surgical removal on balance control. Also, patients benefited faster and better from the postoperative vestibular rehabilitation. Thus, preoperative vestibular rehabilitation, including physical and balance exercises, could help to limit postoperative balance disorders and promote postoperative balance compensation. This could lead to a decrease in the duration and cost of the postoperative management and faster improvement of quality of life.

NCT ID: NCT01743248 Recruiting - Clinical trials for Vestibular Schwannoma

Vestibular Schwannoma and Psychological Factors

Start date: August 2012
Phase: N/A
Study type: Observational

The surgery of a vestibular schwannoma induces balance disorders which have a an impact on the patient's daily life and disrupt their quality of life. But the balance disorders don't seem to be the only ones factors that impaired the patient's quality of life. It has been alrealdy shown that emotional and psychological factors are also related to patient's quality of life. This study evaluates the relationship between the balance control compensation and these factors (i.e. emotional and psychological) in the vestibular schwannoma resection process.