Bürgel U, Mädler B, Honey CR, Thron A, Gilsbach J, Coenen VA Fiber tracking with distinct software tools results in a clear diversity in anatomical fiber tract portrayal. Cent Eur Neurosurg. 2009 Feb;70(1):27-35. doi: 10.1055/s-0028-1087212. Epub 2009 Feb 3.
Coenen VA, Jenkner C, Honey CR, Mädler B Electrophysiologic Validation of Diffusion Tensor Imaging Tractography during Deep Brain Stimulation Surgery. AJNR Am J Neuroradiol. 2016 Aug;37(8):1470-8. doi: 10.3174/ajnr.A4753. Epub 2016 Mar 31.
Patel RR, Liu L, Galatsanos N, Bless DM Differential vibratory characteristics of adductor spasmodic dysphonia and muscle tension dysphonia on high-speed digital imaging. Ann Otol Rhinol Laryngol. 2011 Jan;120(1):21-32.
Poburka BJ, Patel RR, Bless DM Voice-Vibratory Assessment With Laryngeal Imaging (VALI) Form: Reliability of Rating Stroboscopy and High-speed Videoendoscopy. J Voice. 2017 Jul;31(4):513.e1-513.e14. doi: 10.1016/j.jvoice.2016.12.003. Epub 2016 Dec 28.
Zwirner P, Murry T, Swenson M, Woodson GE Effects of botulinum toxin therapy in patients with adductor spasmodic dysphonia: acoustic, aerodynamic, and videoendoscopic findings. Laryngoscope. 1992 Apr;102(4):400-6.
A Phase 2 Trial of Deep Brain Stimulation for Spasmodic Dysphonia
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
