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

Nantes University Hospital (NUH)

Status: Completed

Conditions: Parkinson's Disease

Treatments: Drug: Local Anesthesia (lidocaine hydrochloride); Procedure: Electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02236260

RC14_0060

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Local anesthesia alone

Active Comparator group

Treatment:

Drug: Local Anesthesia (lidocaine hydrochloride)

Local Anesthesia + Electroacupuncture

Experimental group

Treatment:

Procedure: Electroacupuncture

Drug: Local Anesthesia (lidocaine hydrochloride)