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Study on Nimodipine for Hearing Preservation in Patients Undergoing Acoustic Schwannoma Surgery

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What is this study about?

This clinical trial is focused on studying the effects of a medication called nimodipine on preserving hearing after surgery for a condition known as vestibular schwannoma, which is also commonly referred to as an acoustic neuroma. This condition involves a non-cancerous growth on the nerve that connects the ear to the brain, which can affect hearing and balance. The treatment being tested is a solution for infusion, meaning it is administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how effective and safe nimodipine is in maintaining hearing ability after surgery compared to the standard care that patients usually receive. Participants in the study will be randomly assigned to receive either the nimodipine treatment or standard care, which may include a placebo. The study will monitor participants’ hearing function before and after surgery, as well as several months later, to assess any changes or improvements.

Throughout the study, researchers will collect data on the participants’ hearing levels, any changes in their ability to hear, and their overall quality of life. The study will also track any side effects or safety concerns related to the medication, with particular attention to any changes in blood pressure. The trial is expected to continue until March 2026, with participants being followed up for several months after their surgery to gather comprehensive results.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical condition, and hearing function. Written informed consent is required.

2 pre-surgery assessment

Before surgery, a hearing test and MRI scan are conducted to assess the current condition. These tests should be recent, with the hearing test not older than three months and the MRI not older than six months.

3 surgery and initial treatment

Surgery is performed to address the vestibular schwannoma. During this period, the medication nimodipine is administered as a solution for infusion. This is done to help preserve hearing function.

4 post-surgery evaluation

After surgery, hearing function is evaluated before discharge using the Gardner-Robertson scale. This helps determine the immediate effects of the treatment.

5 follow-up assessments

Three to six months after surgery, follow-up assessments are conducted. These include hearing tests and evaluations of cochlear nerve function. The results are compared to pre-surgery levels to assess any changes.

6 quality of life and safety monitoring

Throughout the study, quality of life is assessed using questionnaires. Safety and side effects of the medication are monitored, with particular attention to any changes in blood pressure.

7 end of study

The study concludes with a final evaluation of hearing function and overall health. The results contribute to understanding the effectiveness and safety of the treatment.

Who Can Join the Study?

  • Adults who are 18 years or older can participate.
  • Participants must have a condition called vestibular schwannomas, which is a type of growth in the ear area, and need surgery for it.
  • Participants need to have a hearing test called pure tone audiometry done within 3 months before the surgery. Their hearing should be within a certain range according to a scale called the Gardner-Robertson scale.
  • Participants should have had an MRI scan within 6 months before the surgery. An MRI is a type of scan that helps doctors see inside the body.
  • Participants must provide written informed consent, which means they agree to join the study after understanding what it involves.
  • Participants need to be able to understand and give informed consent, meaning they should understand the study details and agree to participate.
  • Participants must use safe contraception measures if they are of childbearing potential. This means using reliable methods to prevent pregnancy.

Who Cannot Join the Study?

  • Patients who are not diagnosed with acoustic schwannoma cannot participate. Acoustic schwannoma is a type of non-cancerous tumor that affects the nerve responsible for hearing and balance.
  • Patients who are not within the specified age range cannot participate. The age range for this study is from 18 to 64 years old.
  • Patients who are not able to undergo surgery for their condition cannot participate.
  • Patients who have any medical condition that makes it unsafe for them to take the study medication, nimodipine, cannot participate. Nimodipine is a medication used to help protect the brain and nerves.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are unable to give informed consent, meaning they cannot understand the study and agree to participate, cannot participate.
  • Patients who are participating in another clinical trial at the same time cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaetsmedizin Goettingen Goettingen Germany

Other Sites

Site Name City Country Status
HELIOS Klinikum Erfurt GmbH Erfurt Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Mykonwdqjtdxhpdbetmjchspvk Hujbflwbmgwhpfwr Halle (Saale) Germany
Usrhzvdaaajszaioonadc Miipuqez Aro Munster Germany
Unvzyozlljfqcqzxedtsc Wkycacrab Aov Wuerzburg Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
13.01.2021

Trial locations

Investigated drugs:

Nimodipine is a medication being studied for its potential to help preserve hearing after surgery for vestibular schwannoma, a type of non-cancerous brain tumor. The trial is investigating whether taking nimodipine before surgery can protect hearing better than the standard care alone.

Acoustic Schwannoma – Acoustic schwannoma, also known as vestibular schwannoma, is a non-cancerous tumor that develops on the eighth cranial nerve, which is responsible for balance and hearing. This tumor typically grows slowly and can lead to hearing loss, tinnitus (ringing in the ear), and balance issues as it enlarges. As the tumor progresses, it may exert pressure on nearby nerves and structures, potentially causing additional symptoms such as facial numbness or weakness. The growth of the tumor can vary, with some remaining small and others growing large enough to cause significant symptoms. The condition is often diagnosed in middle-aged adults and is not considered a rare disease.

Trial ID:
2024-518182-10-00
Protocol code:
KKSH155
Trial Phase:
Therapeutic confirmatory (Phase III)

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