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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

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Procedure: Electroacupuncture Drug: Local Anesthesia (lidocaine hydrochloride) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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.
Actual Study Start Date : September 3, 2014
Actual Primary Completion Date : June 12, 2017
Actual Study Completion Date : June 14, 2017

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Arm Intervention/treatment
Active Comparator: Local anesthesia alone 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.

Experimental: Local Anesthesia + Electroacupuncture 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.




Primary Outcome Measures :
  1. Patient comfort, judged by "Edmonton Symptom Assessment System" scale (ESAS) [ Time Frame: The day of the DBS procedure ]

Secondary Outcome Measures :
  1. 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 ]
  2. Drug consumption [ Time Frame: The day of the DBS procedure, 2 days after the DBS procedure ]
  3. 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

  4. Adverse effects [ Time Frame: The day before the DBS procedure,the day of the DBS procedure, 2 days after the DBS procedure ]


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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236260


Locations
France
Centre Hospitalier Universitaire de Nantes
Nantes, France, 44000
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Sylvie RAOUL, MD Nantes University Hospital

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02236260     History of Changes
Other Study ID Numbers: RC14_0060
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Anesthetics
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action