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What is the purpose of this study? The study collects and analyzes ongoing data about how the diagnosis and treatment of an acoustic neuroma affect quality of life and what symptoms or problems most impact quality of life. The goal is to develop recommendations to improve quality of life in people with acoustic neuromas or determine what treatment strategies least negatively impact quality of life.
How is the study being done? The study is being done via an electronic REDCap survey. The questionnaire includes 104 questions relevant to your symptoms and quality of life. Most of the questions require checking a box or rating a symptom on a scale of 1 to 10. Completion of the questionnaire is estimated to take approximately 20 minutes. The first year you will be asked to complete the survey twice (six months apart), and then once a year (annually) for approximately 10 years if you choose to continue in the study.
What are my obligations if I agree to participate? Participants need only to complete the questionnaire to the best of their ability, honestly answering each of the questions as they pertain to how they are feeling at the time of completing the survey. There is no cost to you, and you can withdraw or decline to participate at any time. Your decision to participate does not in any way affect your relationship with the Acoustic Neuroma Association (ANA), and no funding from the ANA is being used to complete this study. Your personal information is never shared.
What if I haven't yet had treatment for my acoustic neuroma or had treatment many years ago? It doesn't matter whether you had treatment a long time ago or which treatment strategy you have had (observation or "wait and scan," radiation, or surgery); we want to know how you are doing, what symptoms you are having and how they are affecting your quality of life. Even if you haven't yet had any treatment, knowing how the diagnosis has affected you is helpful to the study.
What if I am doing fine and don't have any symptoms or problems related to my acoustic neuroma or its treatment? Even if you are not currently having symptoms or quality-of-life concerns related to acoustic neuroma, your answers and input may still help determine how more people can live symptom-free and enjoy a high quality of life. In this way, your input may help other people.
What if I have other questions? If you questions about the study, email RSTacousticneuromastudy@mayo.edu.
More information about Mayo Clinic research
How do I get started? Simply email RSTacousticneuromastudy@mayo.edu. Include your name and mailing address. Your first survey link will be emailed shortly after you electronically sign a HIPAA Authorization.
Thank you for your interest in our study,
Michael J. Link, M.D.,Professor of Neurosurgery, Mayo Clinic
Matthew L. Carlson, M.D.,Professor of Otolaryngology and Neurosurgery, Mayo Clinic
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What is the purpose of this study? The study is designed to investigate treatment outcomes in patients with large acoustic neuromas. Large acoustic neuromas tend to compress the brainstem and the facial nerve and in most cases the tumor is tightly adherent to these structures. In such circumstances it is not possible to remove the entire tumor during surgery as it may cause facial paralysis or brainstem complications. It has become a standard of practice for surgeons to remove all (called total resection), about 99% by volume (called near-total resection), or between 80-99% by volume (called subtotal resection) of these tumors depending on tumor characteristics encountered in the operating room. After surgery patients are monitored using MRI scans to make sure the residual tumor does not grow. If the residual tumor shows signs of growth patients receive stereotactic radiation therapy such as Cyberknife or Gammaknife. The potential advantage of leaving small residual tumor would be less chance of facial paralysis and other complications. However, this may come at the expense of residual tumor growth in future. It is our goal to investigate if one can optimize removal of the tumor and preserve excellent facial nerve function without increasing possibility of tumor growth and need for further treatment in future.
Who qualifies to participate? Patients with large acoustic neuromas (measuring 2.5 cm in the widest diameter in cerebellopontine angle) who have never received prior treatment.
What Centers are participating in the study?
- Stanford University, Palo Alto California (Robert Jackler, MD; Nikolas Blevins, MD; John Oghalai, MD)
- George Washington University, Washington DC (Ashkan Monfared, MD)
- Weill Cornell University, New York (Samuel Selesnick, MD)
- University of Iowa, Iowa city (Bruce Gantz, MD; Marlan Hansen, MD)
- University of Texas Southwestern, Dallas (Walter Kutz, MD; Brandon Isaacson, MD)
- Louisiana State University, Baton Rouge and New Orleans (Moises Arriaga, MD)
- Indiana University, Indianapolis (Rick Nelson, MD)
- University of Cincinnati in Ohio and Baylor College of Medicine in Houston are no longer accepting new patients.
Does participating in the study affect what type of treatment options I may have? No, this study is purely a data-collection study and does not, in any way, affect your treatment.
Would the study cover the cost of treatment? No, participants are responsible for the cost of their own treatment which is usually covered by their insurance provider.
Are there any additional costs or financial benefits to participate in the study? No, there will be no additional cost to you or your insurance companies nor any financial rewards because of participating in the study.
Are there any additional risks associated with participating in the study? Participating in the study simply allows the investigators at each institution to follow your progress over the years. There are obviously risks associated with treatment of large acoustic neuromas irrespective of participation in the current study. The data collected at each institution is forwarded to the coordinating Center in an anonymous fashion without containing any names or other personal information. Each participating institution will provide you with a consent form which delineates the details of the study.
What are my obligations if I agree to participate? There are no additional obligations to participate in the study besides what is required for treatment and follow-up of these tumors. You may be asked to fill out a short questionnaire during your visits. There is no cost to you, and you can withdraw or decline to participate at any time. Your decision to participate does not in any way affect your relationship with the Acoustic Neuroma Association®(ANA), and no funding from the ANA is being used to complete this study. Your personal information is never shared.
What if I have other questions? More detail about the study is listed on US National Institute of Health Clinical Trial website. You may also email Dr. Monfared at amonfared@mfa.gwu.edu.
How do I participate? If you are able to receive your treatment at any of the participating Centers, please contact Dr. Monfared to put you in touch with that Center’s coordinator.
Thank you for helping future generations of acoustic neuroma patients by participating in our study,
Ashkan Monfared, MD
Associate Professor of Surgery and Neurosurgery
George Washington University Medical Faculty Associates
Logos for the participating centers:
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Trial for Treatment Refractory Trigeminal Neuralgia
Johns Hopkins Clinical Research Study
Study Description:
What is the purpose of this study?
The purpose of this research study is to determine the effectiveness of the drug Rimegepant in the treatment of people with Trigeminal Neuralgia.
Who can participate?
People with trigeminal neuralgia who have had an inadequate response to other treatments may join.
What will happen if you join this study?
Total study duration is about 9 weeks. Participants will undergo a 2-week screening that includes a clinic visit, blood draw, ECG, physical and neurological exams, survey about your thoughts about suicide, medication and medical history review, and tests for pregnancy, drugs of abuse, HIV and Hepatitis.
During your participation, you may be asked to stop certain medications you currently take for trigeminal neuralgia.
Once screening is complete, participants will start the study drug administration phase that can last up to five weeks. All participants will receive the drug Rimegepant and placebo. At some point during the 5-week treatment period there is a 100% chance you will be assigned “Rimegepant” and a 100% chance that you will be assigned matching placebo. When you receive “Rimegepant” or matching placebo during that time period will be decided by chance (like flipping a coin). During study drug administration you will return for a clinic visit similar to the screening visit four times in those five weeks. Participants will also be asked to complete a daily pain and drug diary. Participants will return for their last visit two weeks after study drug administration ends.
There will be about six visits over the course of the 9-week study duration. There are risks to this study drug that the study team will describe to you.
The study is being conducted for Biohaven Pharmaceuticals, Inc. (BHV). Your study doctor is being paid by BHV to conduct this study.
Eligibility Criteria:
Key Inclusion Criteria
- diagnosis of trigeminal neuralgia with symptoms lasting at least 3 months
- inadequate response to current treatment
- no other cause found on imaging
- normal neurological exam
- on stable doses of all medications for at least 3 months
- 3 months since any prior procedures to treat trigeminal neuralgia
- Age >= 18
- women must not be pregnant, planning to become pregnant during the study period, or breastfeeding
- no other uncontrolled medical conditions
- cannot have a history of gallstones or gallbladder removal
There are other inclusion and exclusion criteria that will be reviewed by the study team before enrollment.
Recruitment Contact Name: Whitney Isennock
Contact Phone: 410-955-7008
Contact E-mail: wwebb10@jhmi.edu
Location of Study Visits
Arizona
Gilbert Neurology Partners/CCT Research
Gilbert, Arizona, United States, 85297
Contact: Jessica Padilla 602-761-9631 jessicapadilla@cctresearch.com
California
Center for Neurohealth: Kaizen Brain Center
La Jolla, California, United States, 92037
Contact: Nancy Tomka 858-294-0161 research@kaizenbraincenter.com
Stanford University
Stanford, California, United States, 94305
Contact: Anthony Bet 650-683-5823 abet0915@stanford.edu
Florida
SouthCoast Research Center
Miami, Florida, United States, 33136
Contact: Lourdes Martinez 786-343-6937 sc2@southresearch.org
Louisiana
Ochsner Baptist Medical Center
New Orleans, Louisiana, United States, 70115
Contact: Colleen Dionne 504-894-2864 colleen.dionne@ochsner.org
Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Contact: Whitney Isennock 410-955-7008 wwebb10@jhmi.edu
Missouri
Clinical Research Professionals
Chesterfield, Missouri, United States, 63005
Contact: Malana Kanallakan 636-220-1200 recruitment@clinicalresearchprofessionals.net
New York
Dent Neurological Institute
Amherst, New York, United States, 14226
Contact: Rebecca Hogan 716-558-5670 rhogan@dentinstitute.com
Neurological Surgery, PC
Lake Success, New York, United States, 11042
Contact: Stephanie Ramjattan 516-478-0008 sramjattan@nspc.com
North Suffolk Neurology
Port Jefferson Station, New York, United States, 11776
Contact: Matthew Kluko 631-629-8810 mkluko@nsneuro.net
Ohio
Neurology Diagnostics Inc.
Dayton, Ohio, United States, 45459
Contact: Taylor Rhodes 937-224-8200 taylor.rhodes@neurologydiagnostics.com
Study will provide compensation: No
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- We are asking you to take part in a study conducted by researchers at the University of California, Irvine. It is our goal to better understand the decision-making process for patients with an acoustic neuroma. We intend to use this data to assess challenges and important factors used to decide on which treatment course to undertake. Identification of these issues can better inform physicians on treatment care.
- You are eligible to participate in this study if you have had a diagnosis of acoustic neuroma.
- Participating in this study is optional. If you choose to participate, please complete this survey, which will take approximately 15 minutes.
- This survey is completely anonymous; no identifying factors will be recorded. No information that you provide will be able to be traced back to you.
- There are no direct benefits from participation in the study, but you will be providing physicians with valuable insight into the decision-making process for those diagnosed with an acoustic neuroma.
- The principal investigators are Dr. Harrison W. Lin and Dr. Hamid R. Djalilian, of the University of California, Irvine. Please email the research team at UCIAcousticNeuroma@gmail.com if you have any questions or concerns.
- To participate in the survey, click on the following link:
https://ci-redcap.hs.uci.edu/surveys/?s=C8F749XXXD
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Speech and Communication in Patients with Facial Paralysis
The goal of this research study is to describe the impact of facial paralysis on oral communication. Surprisingly, there has been little research to date that has measured the effect of facial paralysis or facial weakness on how people verbally communicate. This ten-minute, anonymous online survey will help doctors and researchers understand more about the connection between facial paralysis and communication. This study is led by Dr. Jon-Paul Pepper, a facial nerve surgeon at the University of Southern California.
For more information and to complete the online survey, please click or copy the following link into your web browser:
