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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Benefit Provided by the Addition of Acupunctural Analgesia With Electrostimulation to Conventional Local Anesthesia Compared to Conventional Local Anesthesia Alone in Surgery of Deep Brain Stimulation for Movement Disorders.

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Procedure: Electroacupuncture
* Drug: Local Anesthesia (lidocaine hydrochloride)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Local anesthesia alone<br> | Drug: Local Anesthesia (lidocaine hydrochloride)<br>* All patients will receive injectable paracetamol for pain relief, a mix of nitrous oxide 50% and oxygen 50% for analgesia and lidocaine hydrochloride for local anesthesia.<br>|
| Experimental: Local Anesthesia + Electroacupuncture<br> | Procedure: Electroacupuncture<br>* Acupuncture will be performed using an electrical stimulator (generating electrical stimulation) for electroacupuncture.<br>Drug: Local Anesthesia (lidocaine hydrochloride)<br>* All patients will receive injectable paracetamol for pain relief, a mix of nitrous oxide 50% and oxygen 50% for analgesia and lidocaine hydrochloride for local anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient comfort, judged by Edmonton Symptom Assessment System scale (ESAS) |  | The day of the DBS procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Drug consumption |  | The day of the DBS procedure, 2 days after the DBS procedure | 
| Anesthesia monitoring parameters: heart rate, blood pressure, pulse oximetry | Composite measure | 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 |