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Official Study Title: Treating Speech Disorders in Patients With Parkinson's Disease  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. Using Altered Auditory Feedback
Sponsor: Rush University Medical Center
Clinicaltrials.gov ID: NCT00488657
Study ID: RushUMC

Summary

Speech problems are common in people with Parkinson's disease (PD). At an early stage, people with PD may find it hard to project their voice. As the disease progresses, a person may start to have difficulty starting their speech even though they know the words they want to say. They experience 'freezing' of the jaw, tongue and lips. When they eventually get their speech started, they have a hard time moving it forward. They keep on saying the same words or phrases over and over again while their voice gets softer and softer. Many words also run together or are slurred. These symptoms make the person's speech very hard to understand and directly affect their care and quality of life. Unfortunately, these symptoms have not responded to medication or surgery like other non-speech motor symptoms  Motor SymptomsThe physical symptoms of PD, such as balance, rigidity, tremor, freeze attacks, involuntary movements (dyskinesia), slowness of movement (bradykinesia), walking/gait, postural difficulties*, writing difficulty, swallowing difficulty* (dysphagia), muscle pain*, masked face*, speech problems* and general loss of motor skills. do. In fact, some surgical treatment could even make speech worse while other motor function such as walking improves. Traditional behavior therapy  TherapyAnother word for “treatment”. for these speech symptoms has not been successful either because these symptoms cannot be controlled voluntarily. Recently, we have tested an in-the-ear therapeutic device that provides altered auditory feedback in eight people with PD and moderate to severe speech impairment. The device is housed in a hearing aid shell, and it is programmable. Participants wore the device in one ear and heard their own speech through it after a short time delay and with a shift in pitch while they spoke. For each person, a specific combination of the time-delay and pitch-shift was found. Our preliminary results were encouraging. Seven of the eight people made significant improvements in their speech, and they were much easier to understand when they used the device. This project will systematically examine the therapeutic effect of altered auditory feedback provided by the in-the-ear device on the speech impairments in PD. We will recruit 100 participants with PD and moderate to severe speech impairment for Phase A and 20 for Phase B of the study. The Phase A study will be a single visit while the Phase B study will be over a one-year period while the participants use the device to provide the altered auditory feedback as they speak. Both short-term and long-term benefits of altered auditory feedback on speech will be monitored. Based on the results of our preliminary study, we expect the participants' speech will improve. We hypothesize that the use of altered auditory feedback provides salient sensory information that triggers ancillary loops to allow people with PD to initiate their speech more easily and to maintain a constant speaking rate, thus making their speech more intelligible. This project has the potential to significantly impact the quality of life for people with PD. When they can express their wants and needs and can communicate effectively with their families, caretakers and physicians, their quality of life improves.

Study Phase

Phase 1
What is a study phase?

Symptoms Addressed: Non-movement Symptoms

Speech problems (hypophonic)  HypophonicRelating to hypophonia, or the reduction in the volume and clarity of one's voice.

Time Commitment

• More than six months
• For Phase A: One visit for about three hours. For Phase B: Total of seven visits over one year. Only participants who respond to the device well will be asked to participate in Phase B. The device will be custom-made for Phase B participants.

Eligibility

• Minimum Age: 25
• Maximum Age: 90
• Gender(s) Accepted: Either

Inclusion Criteria

• Parkinson's disease
• Presence of speech problems
• Native English speaker

Exclusion Criteria

• Previous brain surgery
• Presence of dementia  DementiaA decline in higher-level brain functions, such as memory, reasoning and personality. or depression
• Profound hearing loss
• Previous strokes or neurological disorders/conditions other than Parkinson's disease

Enrollment

Expected Enrollment: 100 (US)
Date Enrollment Began: Jun 01 2006
Last Updated Date: Jul 11 2007
Trial Post Date: Jul 11 2007
Website: http://clinicaltrials.gov/ct/show/NCT00488657?order=1

Primary Contacts and Locations

Illinois

• Emily Wang, PhD — Principal Investigator
  Rush University Medical Center
  emily_wang@rush.edu
  Phone: 312-942-5743
  Chicago, IL 60612
  USA