‘CRUSH USH’ The Central Committee on Research Involving Human Subjects (CCMO) has given the Usher Syndrome expertise centre in Radboud UMC permission to actually start the CRUSH study. The CCMO assesses whether medical scientific research complies with the legal stipulations. With this the CCMO guarantees the protection of participants of the study.
The Usher Syndrome Foundation announced that it will finance this five-year study with over €257,000,= already before last summer. This financing of the study was also made possible by the donations of benefactors and co-financing from the Dutch Dr. Vaillantfonds and the Oogfonds.
See the press release ‘Patient and physician jointly take the first step towards treatment of deafblindness’
Study of the natural development for future trials
Research into the natural development of Usher Syndrome is essential in the phase of therapeutic scientific developments. Many and detailed eyesight and hearing measurements are to be recorded in order to be able to measure the effectiveness of a future therapy. Only after studies have demonstrated the effectiveness of a therapy, this will be made available to patients on a large scale.
The international RUSH2a study already received permission from the CCMO and was started after the summer. The 20 patients for this study have already been selected and called up. Now that the CRUSH study has been approved as well by the CCMO, this can be started as well. The first patients will be called in the coming weeks.
Do you want to know more about the substantive differences between the RUSH2a and the CRUSH studies?
Read ‘The RUSH2a and the CRUSH studies’
Below you will find the call by the Radboud UMC.
Call for CRUSH study
Usher Syndrome is a rare, progressive disorder, which apart from congenital loss of hearing also causes eyesight problems in the course of life. At this moment, there is no treatment for Usher Syndrome, but there are promising developments worldwide. An increasing number of centres is developing treatments for the various types of Usher Syndrome aimed at inhibiting or stopping the deterioration of vision and hearing. In order to be able to test the effectiveness of these new medicines in clinical trials, it is important to have a clear picture of the natural development of the disease. The Radboud UMC will soon start the CRUSH study, a study into the natural development of Usher Syndrome type 2. Similar studies will be started for the other types of Usher Syndrome, types 1 and 3, at a later stage.
The CRUSH study and the CRUSH database
The CRUSH study is a four-year study into the increasing loss of eyesight and hearing including 50 patients suffering from Usher Syndrome type 2. The protocol of the CRUSH study is in line with the first international natural development study, the RUSH2A study of Prof. Duncan from California (United States of America), making sure that any exchange of data will be possible. Apart from the CRUSH study, an (international) accessible (anonymous) CRUSH database will be set up in the Radboud UMC for correctly recording and collecting results of tests conducted with patients for future scientific research.
Apply for and participate in the CRUSH study
You can apply for the CRUSH study if you are between 18 and 55 years of age en have a genetically confirmed diagnosis for van Usher Syndrome type 2. Before applying, please take the following into consideration:
– Are you sure you have a genetically confirmed diagnosis for Usher Syndrome type 2 (USH2A, USH2C of USH2D)? If you suffer from another type of Usher Syndrome, you may possibly participate in a later phase, when we start studying Usher types 1 and 3;
– Applying does not guarantee actual participation. We will have a look at your data and decide whether you are suitable for participation. It may happen that, despite the fact that you do suffer from Usher type 2, you cannot participate in the study. One of the most important reasons for this may be that the disease has already advanced so far, that it will be difficult to study the natural development;
– Participation in the study will require quite an investment of time. We will ask you to come to the Radboud UMC for several days during five test series spread over four years. You will also have to complete a number of questionnaires;
– You will not be paid for participation in the study. Of course, your travelling and other expenses will be compensated;
– Participation in the CRUSH study does not guarantee participation in any future study into a medicine.
– Date of birth and age;
– Address and place of residence;
– Telephone numbers, if necessary that of your partner or carer;
– Treating ENT specialist, audiologist and audiologists and the hospitals they work at
We will contact you and schedule a first (telephone) appointment. If applicable, you will then also receive an extensive letter about the content of the study.
With kind regards, on behalf of the Radboudumc expertise centre for Usher Syndrome
Ronald Pennings, Carel Hoyng & Erwin van Wyk
Lieke Knorth-Lintsen, study coordinator CRUSH study firstname.lastname@example.org