Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation (ACUplus)
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electroacupuncture
Local Anesthesia (lidocaine hydrochloride)
Sponsored by
About this trial
This is an interventional supportive care trial for Parkinson's Disease
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
Sites / Locations
- Centre Hospitalier Universitaire de Nantes
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Local anesthesia alone
Local Anesthesia + Electroacupuncture
Arm Description
Outcomes
Primary Outcome Measures
Patient comfort, judged by "Edmonton Symptom Assessment System" scale (ESAS)
Secondary Outcome Measures
Patient anxiety, judged by Hamilton anxiety scale (HAMA)
Drug consumption
Anesthesia monitoring parameters: heart rate, blood pressure, pulse oximetry
Composite measure
Adverse effects
Full Information
NCT ID
NCT02236260
First Posted
August 29, 2014
Last Updated
September 4, 2017
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02236260
Brief Title
Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 3, 2014 (Actual)
Primary Completion Date
June 12, 2017 (Actual)
Study Completion Date
June 14, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Local anesthesia alone
Arm Type
Active Comparator
Arm Title
Local Anesthesia + Electroacupuncture
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Electroacupuncture
Intervention Description
Acupuncture will be performed using an electrical stimulator (generating electrical stimulation) for electroacupuncture.
Intervention Type
Drug
Intervention Name(s)
Local Anesthesia (lidocaine hydrochloride)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient comfort, judged by "Edmonton Symptom Assessment System" scale (ESAS)
Time Frame
The day of the DBS procedure
Secondary Outcome Measure Information:
Title
Patient anxiety, judged by Hamilton anxiety scale (HAMA)
Time Frame
The day before the DBS procedure, the day of the DBS procedure, 2 days after the DBS procedure
Title
Drug consumption
Time Frame
The day of the DBS procedure, 2 days after the DBS procedure
Title
Anesthesia monitoring parameters: heart rate, blood pressure, pulse oximetry
Description
Composite measure
Time Frame
The day of the DBS procedure, 2 days after the DBS procedure
Title
Adverse effects
Time Frame
The day before the DBS procedure,the day of the DBS procedure, 2 days after the DBS procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie RAOUL, MD
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
12. IPD Sharing Statement
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Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation
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