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

Parkinson's Disease Clinical Trial

— ACUplus  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236260
• Other study ID #: RC14_0060
• Status: Completed
• Phase: N/A
• First received: August 29, 2014
• Last updated: September 4, 2017
• Start date: September 3, 2014
• Est. completion date: June 14, 2017

Study information

• Verified date: September 2017
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 14, 2017
• Est. primary completion date: June 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Procedure:
• Electroacupuncture
Acupuncture will be performed using an electrical stimulator (generating electrical stimulation) for 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.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient comfort, judged by "Edmonton Symptom Assessment System" scale (ESAS)		The day of the DBS procedure
Secondary	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
Secondary	Drug consumption		The day of the DBS procedure, 2 days after the DBS procedure
Secondary	Anesthesia monitoring parameters: heart rate, blood pressure, pulse oximetry	Composite measure	The day of the DBS procedure, 2 days after the DBS procedure
Secondary	Adverse effects		The day before the DBS procedure,the day of the DBS procedure, 2 days after the DBS procedure