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

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.

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 Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: Local Anesthesia (lidocaine hydrochloride); Procedure: Electroacupuncture

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44000
    • Centre Hospitalier Universitaire de Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Local anesthesia alone	Drug: Local Anesthesia (lidocaine hydrochloride); 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.
Experimental: Local Anesthesia + Electroacupuncture	Drug: Local Anesthesia (lidocaine hydrochloride); 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.; Procedure: Electroacupuncture; Acupuncture will be performed using an electrical stimulator (generating electrical stimulation) for electroacupuncture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Sylvie RAOUL, MD, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2014
• Primary Completion (Actual): June 12, 2017
• Study Completion (Actual): June 14, 2017

Study Registration Dates

• First Submitted: August 29, 2014
• First Submitted That Met QC Criteria: September 8, 2014
• First Posted (Estimate): September 10, 2014

Study Record Updates

• Last Update Posted (Actual): September 7, 2017
• Last Update Submitted That Met QC Criteria: September 4, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: RC14_0060