Efficacy of Voice Treatment for Parkinson's Disease

This is a research project designed to look at various areas of function, such as speech,
voice, swallowing, related communication behaviors and body movement of individuals with
idiopathic Parkinson disease (PD) and to investigate how two different forms of speech
therapy affect these areas.

We are asking up to 620 individuals to participate in this study in several different ways.
Specifically, there is an experimental group (ExpG), questionnaire group (QG) and
communication partner group (CPG). The ExpG will be composed of individuals with PD and the
healthy age and gender matched controls (HC)(Up to 140 total will be asked, 80 expected to
complete the study). The QG will include the significant others, family members, and friends
of the ExpG (Up to 140 will be asked, 80 expected to complete the study). The CPG will be
made up of friends of the ExpG (Up to 340 will be asked, 240 expected to complete the
study).Some individuals in the ExpG may not pass the initial screenings. As a result, their
QG and CPG will no longer need to participate. Therefore, the actual number of individuals
who will complete the study is expected to be much less.

There are 10 PHASES of this study. The initial PHASES (1,2,3) are screening PHASES to
determine if the individual is a good candidate for this study. PHASES 4, 6 and 10 are PHASES
of recording data and PHASE 5 is treatment. PHASES 7, 8 and 9 are additional assessments. The
total duration of the Subjects (Ss) participation from the time Ss sign the consent to the
completion of the last phase (PHASE 10) is approximately10 months.

PHASE 1: ENT/CLINICAL VOICE AND SPEECH SCREEN PHASE 2: SWALLOW SCREEN AND ASSESSMENT PHASE 3:
THINKING SKILLS SCREEN AND ASSESSMENT After the completion of PHASES 1-3, the research team
will look at the data collected and determine if the Ss meet the criteria to participate in
this study. If asked to participate, Ss will be assigned to one of four groups and then
continue with PHASE 4.

PHASE 4: INITIAL DATA RECORDINGS All of the procedures in PHASE 4 will be done two times
before the treatment PHASE 5. Each recording will take approximately 2-2.5 hours.

PHASE 5: TREATMENT PHASE 6: POST TREATMENT PHASE DATA RECORDINGS PHASE 7: FOLLOW-UP ENT
EVALUATION PHASE 8: FOLLOW-UP SWALLOW EVALUATION PHASE 9: FOLLOW-UP THINKING SKILLS
EVALUATION PHASE 10: 6-MONTH POST TREATMENT PHASE DATA RECORDINGS

Inclusion Criteria:

- Idiopathic Parkinson's Disease (IPD)

- None or mild dementia

- None, mild or moderate depression

- Mild, moderate or severe speech, voice, and swallowing disorder

Exclusion Criteria:

- Severe depression

- Moderate or severe dementia

- Symptoms of another neurological condition other than or in addition to IPD or drug
abuse

- Head or neck cancer

- Significant history of gastrointestinal disease or surgery

- Speech or voice disorders unrelated to IPD

- Neurosurgery, not for management of PD symptoms

- Laryngeal pathology/surgery

- Full-course Lee Silverman Voice Treatment (LSVT®)

- Smoked in last four years

- Absence of speech, voice or swallowing disorder

- Severe temporomandibular joint disorder

- Pregnancy (or the possibility of pregnancy)

- Hearing loss unexpected for his/her chronological age