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Completed

NCT Number: NCT02236260

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Nantes

Nantes, 44000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electroacupuncture

Procedure

Acupuncture will be performed using an electrical stimulator (generating electrical stimulation) for electroacupuncture.

Local Anesthesia (lidocaine hydrochloride)

Drug

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 outcomes

  1. Patient comfort, judged by "Edmonton Symptom Assessment System" scale (ESAS)

    Time frame: The day of the DBS procedure

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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.

Acronym: ACUplus

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 10, 2014
Registry last updated
Sep 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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