Lab Projects

Efficay of Voice Treatment for Parkinson's Disease

Generation of the first voice treatment efficacy data has provided important information about the mechanisms underlying the voice disorder in idiopathic Parkinson's Disease IPD, and has identified fundamental elements of treatment-related change. The work proposed here builds upon this well-established foundation of data to evaluate the system-wide generalized impact of voice and articulation treatments on swallowing in patients with IPD. One hundred patients with IPD who have been scheduled for a voice and articulation therapy program will be enrolled. There will be four subject groups: two forms of treatment ((1)LSVT, 20 subjects with Ideopathic Parkinson’s Disease [IPD] and (2) Articulation (ARTIC), 20 subjects with IDP) and a (3) control group of 20 untreated individuals with IPD and (4) 20 untreated healthy aging adults. 40 Ss with IPD will receive one of two forms of high effort, intensive treatment (voice treatment: LSVT, or articulation treatment: ARTIC). Subjects will receive a modified barium swallow study prior to the initiation of their voice and articulation therapy in order to assess their level of swallowing function. After completion of their 6 week course of voice and articulation therapy, they will receive a second modified barium swallow test to determine whether the voice and articulation therapy program had any impact on their swallowing function. This study is funded by NIH/NIDCD R01DC01150 in collaboration with Lorraine Ramig, Ph.D., at the University of Colorado Boulder.

Oropharyngeal Function After Radiotherapy with IMRT

This goal of this project is to define the effects on swallowing of intensity modulation during radiotherapy in an organ preservation treatment protocol involving chemoradiation for 125 oral, laryngeal, and pharyngeal cancer patients with previously untreated Stage III or IV disease and to identify optimum treatment strategies. The specific aims are: 1) define the physiologic effects of chemoradiotherapy with IMRT to various sites in the upper aerodigestive/vocal tract icluding the cervical esophagus and the rate at which patients return to oral intake; 2) document the acute toxicities, late complications, locoregional failure and survival, and the relationship between fibrosis rating and the measure of laryngeal elevation; 3) determine whether the patient’s swallowing mechanism can compensate for physiologic deficits in swallowing by introduction of interventions (postural changes, voluntary swallow maneuvers, several bolus volumes); 4) determine whether time to return to oral intake, effects of swallow maneuvers and/or volume, presence of an esophageal stricture and the duration of success of dilatation depends on radiation dose volume to specific structures in the head and neck; 5) define the relationship of tongue base pressure to development of esophageal stricture. Effects are defined in terms of swallowing function, morbidity, toxicity and survival. Other outcome measures are the maintenance of voluntary control (flexibility) of the oropharyngeal region as indicated by the ability to correctly produce swallow maneuvers; and positive changes in cricopharyngeal opening duration with normal bolus volume shifts. Patients are studied pretreatment, and at 1 month, 3 months, 6 months, 12 months, and 24 months post completion of chemoradiation. At each assessment, patients receive a videofluoroscopic assessment of swallowing utilizing a standard protocol, assessment of xerostomia, mucositis, and fibrosis as well as assessment of disease status. Head and neck cancer is a severe problem that affects public health. Most current treatments are a combination of radiotherapy with chemotherapy, which can result in severe swallowing problems which may make patients unwilling to accept this type of treatment. This project attempts to quantify the swallow problems associated with this specific treatment and the effects of interventions for these swallow problems. This project is funded by NIH/NCI R01 DC007659.

Pilot Study of the Effect of Botulinum Toxin Type A Treatment on Swallowing in Patients with Cervical Dystonia (MedAff-BTX-0716)

Spasmodic torticollis is a form of focal dystonia involving the muscles of the neck and is thus more commonly referred to as cervical dystonia. As a result of the abnormal involuntary contractions of the neck muscles, the head may be rotated, tilted, flexed, extended, or any combination of these postures. The movements may be quick, sustained, or patterned and may be associated with tremor. Most cases of cervical dystonia are idiopathic and it is generally a life-long disorder. Treatment with injections of botulinum toxin type A has become the standard of care to provide relief from the motor symptoms and accompanying pain and discomfort. Patients with cervical dystonia have been reported to experience difficulties with swallowing due to the dystonic contractures of the muscles of the neck and muscles of swallowing, due to the altered position of their head and neck and due to the effects of therapy with botulinum toxin. Little is known about the actual details of the swallowing problems experienced by patients with cervical dystonia, particularly with regards to the actual muscles involved and the steps of the swallowing process that might be affected, both before and after botulinum toxin type A therapy.The objectives of this study are to evaluate and quantitate oropharyngeal swallowing efficiency using videofluoroscopy in patients with cervical dystonia before and after treatment with 750 U of Dysport®. Patients with successfully treated cervical dystonia that have completed Study MedAff BTX-0616 will be studied. The primary outcome variable will be the oropharyngeal swallow efficiency (OPSE) as described in Rademaker, A. W., B. R. Pauloski, et al. (1994). J Speech Hear Res 37(2): 314-25. Secondary outcomes will consist of the components of swallowing measured by videofluoroscopy as determined using multiple consistencies of barium containing liquids, pastes and solids. This is a single-center, open label pilot study in 30 patients. Study duration is approximately 5 weeks and consists of up to 4 study visits. Subjects will receive one cycle of Dysport® injections at Visit 1 (Baseline Injection Visit) and will be followed for 4 weeks post injection, with evaluations at baseline, week 2 and week 4 after treatment. Swallowing videofluoroscopy will be performed at baseline and week 2. This study is funded by Allergan Sales, LLC.

Efficacy of Electrical Stimulation for Dysphagia in Head and Neck Cancer Patients

Head and neck cancer patients have a better chance of survival in the 21st century because radiation therapy (RT), either alone or in combination with surgery and/or chemotherapy (CRT) diminishes local recurrence, improves the chances of cure, and in some cases extends duration of life. Unfortunately the elimination of the cancer can leave devastating side effects, including the inability to eat and swallow normally. Organ preservation, originally assumed to be the preferred treatment, has now been shown to magnify a dysphagia. Conventional therapy for dysphagia yields only minor benefit and its persistence has a major impact on the quality of life of these cancer survivors. Recently, a new therapy approach has been introduced for dysphagia, called e-stim or Neuromuscular Electrical Stimulation (NMES). Through low voltage current delivered through the skin, motor nerves are excited, causing muscle contraction. There are no efficacy studies demonstrating its true benefit, and no studies targeting head and neck cancer patients with dysphagia. In this randomized clinical trial, we propose to compare NMES therapy to sham NMES therapy on post-radiated H&N cancer patients with severe dysphagia. Both arms of the study will also include traditional therapy, consisting of exercises for the tongue, pharynx, and larynx. Patients will undergo therapy for 12 weeks with an aggressive, daily home program. Objective indicators of a change in swallow function will the quantified by measures taken from fluoroscopy studies. Subjective measures of change will be taken from patient self-reported quality of life which will indicate whether they perceived a benefit from the therapy. Following a 6-week rest period after the completion of therapy, measures will be taken once again to determine the permanence of the effect. This new treatment may represent the first real hope for this growing cancer patient population but it is unsubstantiated. If successful, this study will stimulate a multitude of translational research studies to elucidate the mechanisms underlying this new treatment. This study is funded by NIH/NCI R01CA120950 in collaboration with Susan Langmore, Ph.D., at Boston University Medical School.