Clinical Trials

Clinical trial and research studies are a crucial part to better understand spasmodic dysphonia. The NSDA provides information on this research study in order to further the scientific understanding of spasmodic dysphonia, but the NSDA does not endorse or recommend participation in this or any other medical research studies.

Research Trial - San Francisco, CA

A new study is enrolling in San Francisco: Timing of Neural Activity in Spasmodic Dysphonia - Researchers John Houde, PhD, Srikantan S. Nagarajan, PhD, Katherine Yung, MD, and colleagues are seeking volunteers to participate in spasmodic dysphonia research study. The main objective of this research is to determine how spasmodic dysphonia of the voice affects brain activity during speaking using state-of-the-art noninvasive neuroimaging techniques.

In this study, we seek to determine how spasmodic dysphonia (SD) of the voice affects brain activity during speaking. The study is open to patients who have been diagnosed with the adductor SD and have a history of a positive response to at least three injections of botulinum toxin (botox). Patients must also have had their last botox treatment no sooner than

three months prior to participation. The study has three sessions. First, in a 60 minute session, we measure the patient's voice characteristics at the UCSF Voice and Swallowing Center. Second, in a two-hour session, brain activity is measured using magnetoencephalography (MEG), which is completely non-invasive and silent. This is completed at the UCSF Biomagnetic Imaging Laboratory. In this portion, patients first have electrodes placed on their neck to monitor muscle activity in their larynx. Then the patient will lie on their back with their head in the MEG scanner, and speak vowels while the scanner records their brain activity. As the patient speaks, their voice is picked up by a microphone and played back to

them via earphones. Third, after the MEG experiment, in a 30-minute session, magnetic resonance imaging (MRI) of the brain is completed at UCSF Mission Bay. We prefer to run the three sessions of the study on the same day, but if necessary, they can be completed on separate days. Please contact Sarah Schneider at 415.885.3780 if you are interested in participating.

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Research Trial - Minneapolis, MN

The Program of Physical Therapy and Rehabilitation Science at the University of Minnesota is conducting a research study titled: Pathophysiology of Laryngeal dystonia: a combined TMS and fMRI study. The purpose of the study is to use magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS) to determine the structure and excitability of the brain between healthy subjects and those diagnosed with laryngeal dystonia or spasmodic dysphonia to gain a better understanding of the cause of the disorder. TMS is a safe, non-invasive, painless procedure which allows researchers to measure the excitability of portions of the brain. A physician will place fine wire electrodes into the vocal cord muscle to monitor activity.

Requirements

Greater than 18 years of age, but we are especially in need of people 55-70 years of age.

Symptoms of laryngeal dystonia, spasmodic dysphonia or healthy person without dystonia

No history of seizure within the last two years

Participation includes two sessions lasting 2-3 hrs. At the completion of the study you will be paid $100

For more information, please contact Rebekah at (952) 626-0637 or schm2203@ umn.edu

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Patient Database - Epilespy and Spasmodic Dysphonia

Do you have SD and a vagal stimulator for the treatment of epilepsy? If so we need your help.

At the Voice and Swallowing Institute at New York Eye and Ear Infirmary of Mount Sinai, Dr. Michael Pitman and his team have been studying low level electrical stimulation as an alternative treatment for spasmodic dysphonia. The hope is to one day implant an electrical stimulator for the treatment of spasmodic dysphonia, as an alternative of botulinum toxin injections. The background to this research and the pilot data of the first study were recently published in the medical journal Laryngoscope. As a follow up, they are considering further investigation in patients who have had a vagal stimulator placed for the treatment of epilepsy but also happen to have spasmodic dysphonia. They are creating a databank of such patients in order to evaluate the utility of pursuing future research. If you are such a patient, for further information, please contact Nina Suslina, Research Coordinator, at New York Eye and Ear Infirmary of Mount Sinai at 212-979-4071 or nsuslina@nyee.edu. 

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Research Trial - New York, NY

Imaging Genetics of Spasmodic Dysphonia
Kristina Simonyan, MD, PhD, Principal Investigator
Grant award: NIH/NIDCD R01DC011805

Funded by the National Institute on Deafness and other Communication Disorders (NIDCD/NIH), we are conducting a 5-year investigation to determine the extent of relationship between genetic risk factors and brain changes in patients with spasmodic dysphonia (SD). Eligible patients will have adductor and abductor SD with or without family history of dystonia. The study will include an assessment of SD symptoms through detailed examination of clinical features of disorder, functional and structural brain imaging with MRI for identification of brain abnormalities associated with a genetic predisposition, and a blood donation (about 2 tablespoons) for identification of possible genetic risk factors of SD.

We hope that determination of brain mechanisms that are affected by SD risk gene(s) would ultimately lead to establishment of enhanced criteria for better clinical management of SD, including its improved detection, accurate diagnosis, and new treatment alternatives

All studies will be conducted at the Mount Sinai School of Medicine in New York City, NY. The team of investigators includes Kristina Simonyan, M.D., Ph.D. (Principal Investigator), Laurie Ozelius, Ph.D. (Geneticist), Andrew Blitzer, M.D. (Otolaryngologist), Steven Frucht, M.D. (Neurologist), Miodrag Velickovic, M.D. (Neurologist), and Inga Peter, Ph.D. (Statistician).

Study Details

Purpose of this research study: Investigate changes in the brain of patients with spasmodic dysphonia.

You may qualify if:
• You have spasmodic dysphonia, you are unaffected family member of a patient with spasmodic dysphonia, or you are a healthy volunteer
• You wish to participate in the brain magnetic resonance imaging (MRI) study
• You wish to provide small amount of blood (about 2 tablespoons) for genetic testing
• You are18 through 80 years of age

You may not qualify if:
• You have a history of other neurological, psychiatric or voice problems

Place and Time
The outpatient research study will be conducted at the Mount Sinai Hospital in New York and may last up to three hours. Cost There is no cost in participation in the study or any test associated with the research. You will be reimbursed for your time in the amount of $50, which you will receive in form of a check. If you are an out-of-town patient, your travel costs to the Mount Sinai Hospital for this study may be reimbursed.

Please contact our research team at (212) 241-8729 or via e-mail at dystonia.research@gmail.com to receive more information about the study and your eligibility.

This study was approved by the Institutional Review Board of the Mount Sinai School of Medicine on 01/03/2012.

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Clinical Trial - New York, NY

Researchers at the Mount Sinai School of Medicine Columbia University are studying spasmodic dysphonia and essential tremor of voice. Purpose of this research study is to investigate effect of a novel drug, sodium oxybate, on symptoms and brain changes in patients with spasmodic dysphonia and essential tremor of voice.

You may qualify if:
- You have spasmodic dysphonia and/or essential tremor of voice or you are a healthy volunteer;
- Your symptoms are relieved with alcohol;
- You wish to participate in the brain functional magnetic resonance imaging (fMRI) study;
- You are 18 through 75 years of age.

You may not qualify if you have a history of other neurological, psychiatric or voice problems.

Place and Time: The outpatient research study conducted at the Mount Sinai Hospital will include fMRI, which may require up to 2 separate visits, each lasting up to 1 hour.

Cost: There is no cost in participation in the study or any tests associated with the research. If you are a healthy volunteer, you will have only fMRI performed and you will be reimbursed for your time in amount of $50.

This study was approved by the by the Institutional Review Boards of the Mount Sinai School of Medicine on 07/28/2010.

For more information, please call 212- 241-0656. Ask to speak to Dr. Kristina Simonyan, M.D., Ph.D.