Clinical trial NCT02236260: Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient comfort, judged by "Edmonton Symptom Assessment System" scale (ESAS)
timeFrame: The day of the DBS procedure
Secondary outcomes:
measure: Patient anxiety, judged by Hamilton anxiety scale (HAMA)
timeFrame: The day before the DBS procedure, the day of the DBS procedure, 2 days after the DBS procedure
measure: Drug consumption
timeFrame: The day of the DBS procedure, 2 days after the DBS procedure
measure: Anesthesia monitoring parameters: heart rate, blood pressure, pulse oximetry
timeFrame: The day of the DBS procedure, 2 days after the DBS procedure
measure: Adverse effects
timeFrame: The day before the DBS procedure,the day of the DBS procedure, 2 days after the DBS procedure
Other outcomes:
Locations:
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Sylvie RAOUL, MD
role: PRINCIPAL_INVESTIGATOR
References: