Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Procedure: Electroacupuncture; Drug: Local Anesthesia (lidocaine hydrochloride)

• Registration Number: NCT02236260
• Lead Sponsor: Nantes University Hospital

Brief Summary

The effectiveness of Deep Brain Stimulation (DBS) in certain movement disorders is widely demonstrated. The success of this procedure requires that the patient is awake and cooperative. The conditions of this intervention can be difficult to tolerate by the patient for several reasons: long procedure (from 3 to 8 hours), body immobilisation (particularly the head in the stereotactic frame), stress related to the localization of the DBS. It is therefore important to improve the comfort as well as the cooperation of the patient, during implantation of the DBS electrodes, in order to optimize the conditions of the intervention. In addition to analgesia, acupuncture should allow sedation without affecting alertness and should contribute to the regulation of any vegetative reactions during the procedure. Therefore, we hypothesize that acupuncture could improve the quality of care of the patient during a DBS procedure. In practice, this is electroacupuncture that will be used in this research to maintain the stimulation of acupuncture points to an optimal level during the time of the intervention.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-29
• Study Start: 2014-09-03
• Study First Submitted QC: 2014-09-08
• Study First Posted: 2014-09-10
• Primary Completion: 2017-06-12
• Study Completion: 2017-06-14
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-04
• Last Update Posted: 2017-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients from both sexes aged who are >= 18 years
• Disabling movement disorders, resistant to medical treatment, in Parkinson's patients who should benefit from a Deep Brain Stimulation in the subthalamic nucleus
• Scheduled intervention of a Deep Brain Stimulation
• Understanding of acupunctural analgesia with electrostimulation
• Signed informed consent
• Membership to a social security insurance scheme

Exclusion Criteria

• Patients who are >= 75 years
• History of intolerance to acupuncture
• Contraindications to local anesthesia
• Respiratory problems (asthma, COPD, ...)
• Holder of an implanted pacemaker
• Obesity with BMI > 30
• History of motion sickness
• Unstabilized psychiatric disorders
• Impaired cognitive functions
• Pregnancy
• Breastfeeding
• Minors
• Major under a legal protection regime

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local Anesthesia + Electroacupuncture	Electroacupuncture	-
Local Anesthesia + Electroacupuncture	Local Anesthesia (lidocaine hydrochloride)	-
Local anesthesia alone	Local Anesthesia (lidocaine hydrochloride)	-

Primary Outcome Measures

Name	Time	Method
Patient comfort, judged by "Edmonton Symptom Assessment System" scale (ESAS)	The day of the DBS procedure

Secondary Outcome Measures

Name	Time	Method
Patient anxiety, judged by Hamilton anxiety scale (HAMA)	The day before the DBS procedure, the day of the DBS procedure, 2 days after the DBS procedure
Adverse effects	The day before the DBS procedure,the day of the DBS procedure, 2 days after the DBS procedure
Drug consumption	The day of the DBS procedure, 2 days after the DBS procedure
Anesthesia monitoring parameters: heart rate, blood pressure, pulse oximetry	The day of the DBS procedure, 2 days after the DBS procedure	Composite measure

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Nantes; 🇫🇷 Nantes, France