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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-03

Study Completion Date

2017-06-14

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.

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Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Local anesthesia alone

Group Type ACTIVE_COMPARATOR

Local Anesthesia (lidocaine hydrochloride)

Intervention Type DRUG

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.

Local Anesthesia + Electroacupuncture

Group Type EXPERIMENTAL

Electroacupuncture

Intervention Type PROCEDURE

Acupuncture will be performed using an electrical stimulator (generating electrical stimulation) for electroacupuncture.

Local Anesthesia (lidocaine hydrochloride)

Intervention Type DRUG

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.

Interventions

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Electroacupuncture

Acupuncture will be performed using an electrical stimulator (generating electrical stimulation) for electroacupuncture.

Intervention Type PROCEDURE

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.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No