A Study of the Effect of Deep Brain Stimulation on Constipation and Anosmia in Parkinson Disease
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Sponsor Protocol Number: 15-005903
About this study
The purpose of this study is to investigate the effects of subthalamic nucleus and globus pallidus interna deep brain stimulation on bowel symptoms and the ability to smell things in patients with Parkinson disease and constipation.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Have Parkinson's Disease, and recruited from Deep Brain Stimulating Clinic during work-up for deep brain stimulation
- UK Parkinson’s Disease Society Brain Bank Clinical diagnostic criteria for PD with medication-resistant motor fluctuations, dyskinesia or tremor
- A history of symptoms of chronic constipation for 12 months
- Symptoms of chronic constipation as defined by Rome criteria
- Stable medication history defined as no changes in regimen for at least 3 weeks prior to the baseline period
- Significant cognitive impairment, as defined by Litvan consensus criteria for PD with impairment ≥ 2 SD below the mean on two or more tests within a comprehensive neuropsychological evaluation
- Another likely cause for constipation (e.g. colon cancer, untreated hypothyroidism, opioids)
- Anticholinergic medications used to treat PD will not be considered as exclusion criteria
- Another cause for impaired olfaction (e.g. head injury, active sinusitis, active smoker)
Publications are currently not available