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Official Study Title: Sensory Dysfunction in Early Parkinson’s Disease
Sponsor: Department of Defense
Clinicaltrials.gov ID:
Study ID: USAMRAA W81XWH-09-1-0467

Summary

Parkinson’s disease (PD) has been associated with altered sensory function, including changes in vision, hearing, smell, touch, taste and balance.  This study aims to definitively establish the sensory anomalies that occur in early stage PD, determine their associations with one another, compare their relative sensitivity in discriminating between patients with early PD and people without PD, establish whether they rival or exceed the sensitivity of in vivo (whole-body) SPECT dopamine  DopamineA "chemical messenger" that regulates movement by assisting in the effective communication (transmission) of electrochemical signals in the brain from one nerve cell (neuron) to another. As dopamine producing cells degenerate with advancing PD, they no longer produce enough to regulate neurons elsewhere in the brain, resulting in a loss of control of movements, leading to symptoms such as slowed movements, tremor, and rigidity. transporter imaging in detecting early PD, and determine to what degree the sensory changes are influenced by dopamine therapy.  TherapyAnother word for “treatment”.  

Sensory tests are administered twice, once while on dopamine therapy (for a minimum of six weeks) and once while off of dopamine therapy (for a minimum of 10 days).  Included in the assessment battery are tests of olfaction (odor identification, detection and memory, taste (chemical and electrical), touch (touch sensitivity and gap discrimination), vision (acuity or sharpness, contrast sensitivity, color discrimination, pattern electroretinography, which measures the electrical responses of various cell types in the retina), hearing (pure-tone thresholds to determine hearing loss, filtered words, auditory figure-ground to check how participants can pick out certain sounds, competing words and sentences, staggered spondaic words, pitch-pattern sequences and evoked potentials, which are measured from the nervous system), and balance (function of the vestibular system, which provides a sense of balance, and posturography to determine posture control).

Study Phase

Not Applicable
What is a study phase?

Symptoms Addressed: Non-movement Symptoms

Walking/Gait,  GaitWay of walking, which is diminished in people with Parkinson’s who tend to shuffle their feet, take too short steps, and not swing one or both arms. Vision Changes, Rigidity,  RigidityA symptom in which muscles feel stiff and display resistance to movement even when another person tries to move the affected part of the body. Retinal deterioration, Postural difficulties, Loss of Motor Skills, General PD symptoms, Diminished sense of smell, Balance

Time Commitment

• Less than one month
• Two four-day periods separated from one another by a minimum of two weeks

Eligibility

• Minimum Age: 45
• Maximum Age: 65
• Gender(s) Accepted: Either
• Maximum Years Since Diagnosis: 3
• Study is enrolling non-PD participants

Exclusion Criteria

• History of repeated strokes
• History of significant head trauma
• History of drug abuse
• History of definite encephalitis
• History of oculogyric crises (reactions to certain drugs)
• Supranuclear gaze palsy other than restricted upgaze
• Cerebellar signs (disorder of the cerebellum in the brain)
• Early severe autonomic involvement
  Severe dementia
• Intracranial abnormalities that may complicate interpretation of the brain scans (e.g., stroke, tumor, vascular abnormality affecting the target area)
• Pregnancy
• History of chronic nasal sinus disease
• Allergies to odorants
• Presence of an upper respiratory infection or any other potentially confounding non-PD-related condition that is known or likely to interfere with sensory function

Enrollment

Expected Enrollment: 80 (US)
Date Enrollment Began: Jul 2009
Date Enrollment Ends: Dec 2013
Last Updated Date: Nov 11 2011
Trial Post Date: Nov 11 2011
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