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

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

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.

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

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

More Information

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT02236260
• Other Study ID Numbers: RC14_0060
• First Posted: September 10, 2014
• 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; Synucleinopathies; Neurodegenerative Diseases; Lidocaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; 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