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

Nantes University Hospital20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Parkinson's Disease

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Patient comfort, judged by "Edmonton Symptom Assessment System" scale (ESAS)

Time frame: The day of the DBS procedure

Secondary Outcomes

Patient anxiety, judged by Hamilton anxiety scale (HAMA)

Time frame: The day before the DBS procedure, the day of the DBS procedure, 2 days after the DBS procedure

Drug consumption

Time frame: The day of the DBS procedure, 2 days after the DBS procedure

Anesthesia monitoring parameters: heart rate, blood pressure, pulse oximetry

Composite measure