Effect of Deep Brain Stimulation on Gastrointestinal (GI) Motility (SCP-Comodig)

University Hospital, Rouen

Status: Completed

Conditions: Parkinson's Disease

Treatments: Device: Deep brain stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01081457

2008/163/HP

Details and patient eligibility

About

Parkinson's disease is characterized by extra-pyramidal symptoms as well as digestive involvement with gastrointestinal motility (GI) impairment. Deep brain stimulation has been recently developed as a successful treatment for extrapyramidal symptoms. In addition, preliminary reports suggest that this therapy might be successful to relieve GI symptoms as well. The aim of this study is therefore to assess the effect of deep brain stimulation on GI voluntary as well as involuntary motility.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient over 18 yo
• patient with Parkinson's disease implanted for deep brain stimulation
• patient responders to deep brain stimulation (UPDRS improved by at least 40%)
• patient covered by the french health care system
• patient not taking anti-parkinsonian medication the day before evaluation
• French speaking

Exclusion criteria

• patient below 18 yo
• pregnancy
• Severe psychiatric or cognitive disorders
• diabetes mellitus
• morbid obesity
• compulsive eating disorders
• diffuse GI motility impairment (except Parkinson's disease)
• other evolutive neurologic disorders
• previous history of significant GI resection
• inability to swallow or defecate when asked

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

16 participants in 2 patient groups

ON

Active Comparator group

Description:

Stimulator switched ON

Treatment:

Device: Deep brain stimulation

OFF

Sham Comparator group

Description:

Stimulator switched OFF

Treatment:

Device: Deep brain stimulation