Deep Brain Stimulation and Digestive Symptomatology

Effects of Subthalamic Nucleus Deep Brain Stimulation on Gastrointestinal Symptoms and Motility in Parkinson's Disease.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00639275

Acronym

SCPDig

Enrollment

Registered

2008-03-20

Start date

2008-06-30

Completion date

2012-06-30

Last updated

2013-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Brief summary

Patients with Parkinson's disease (PD) frequently experience upper gastrointestinal disorders. During the disease, weight loss is often noticed. Recently, many studies have demonstrated that STN-DBS improved extrapyramidal symptoms. Interestingly, PD patients gain weight after STN-DBS, at least in part due to a decrease in resting energy expenditure. Purpose: To evaluate benefits of STN-DBS on upper gastrointestinal symptoms and motility. Patients et method: PD patients waiting for STN-DBS, will be assessed in a preoperative time (2 times at, at least, 3 month intervals, to evaluate the natural history of the disease on upper gastrointestinal symptoms and motility) and in a postoperative time, after 6 months of chronic STN-DBS. Each assessment will include : 1/ questionnaires about frequency and severity of upper gastrointestinal symptoms; 2/ a nutritional assessment (body mass index, dietary assessment); 3/ the gastric emptying measurement with the 13C-octanoic acid breath test; 4/ the colorectal transit time measurement with radio-opaque markers 5/ an indirect calorimetry to estimate resting energy expenditure; 6/ and plasmatic leptin and ghrelin concentrations, hormones involved in the homeostatic regulation of appetite. Perspectives: This physiopathological study should allow us to understand the mechanisms of the effects of STN-DBS on upper gastrointestinal symptoms and weight regulation in PD patients.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Parkinson's disease * Electrode implantation for deep brain stimulation in progress * Age \<70 yr * Motor fluctuations and dyskinesias * Motor symptoms improvement with L-dopa \> 50% * No dementia * No depression * No major psychiatric symptom * Normal brain MRI

Exclusion criteria

* Contra-indication of neurosurgery * Pregnancy * Diabetes * Obesity * Compulsive eating disorders * Organic digestive disease * Gastrointestinal resection * Prokinetic treatment * Coagulopathy

Design outcomes

Primary

Measure	Time frame
the gastric emptying measurement with the 13C-octanoic acid breath test	M0 and M6

Countries

France

Outcome results