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

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ClinicalTrials.gov Identifier: NCT02236260
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : September 7, 2017
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date  ICMJE August 29, 2014
First Posted Date  ICMJE September 10, 2014
Last Update Posted Date September 7, 2017
Actual Study Start Date  ICMJE September 3, 2014
Actual Primary Completion Date June 12, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2014)		 Patient comfort, judged by "Edmonton Symptom Assessment System" scale (ESAS) [ Time Frame: The day of the DBS procedure ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2014)
  • 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 ]
  • Drug consumption [ Time Frame: The day of the DBS procedure, 2 days after the DBS procedure ]
  • Anesthesia monitoring parameters: heart rate, blood pressure, pulse oximetry [ Time Frame: The day of the DBS procedure, 2 days after the DBS procedure ]
    Composite measure
  • Adverse effects [ Time Frame: The day before the DBS procedure,the day of the DBS procedure, 2 days after the DBS procedure ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Local anesthesia alone
    Intervention: Drug: Local Anesthesia (lidocaine hydrochloride)
  • Experimental: Local Anesthesia + Electroacupuncture
    Interventions:
    • Procedure: Electroacupuncture
    • Drug: Local Anesthesia (lidocaine hydrochloride)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2014)		 20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 14, 2017
Actual Primary Completion Date June 12, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02236260
Other Study ID Numbers  ICMJE RC14_0060
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Nantes University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Nantes University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sylvie RAOUL, MD Nantes University Hospital
PRS Account Nantes University Hospital
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP