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

NCT02236260 | Completed

• 1 other identifier: RC14_0060
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

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

  The day of the DBS procedure

Secondary Outcomes (4)

• Patient anxiety, judged by Hamilton anxiety scale (HAMA)

  The day before the DBS procedure, the day of the DBS procedure, 2 days after the DBS procedure

• Drug consumption

  The day of the DBS procedure, 2 days after the DBS procedure

• Anesthesia monitoring parameters: heart rate, blood pressure, pulse oximetry

  The day of the DBS procedure, 2 days after the DBS procedure

• Adverse effects

  The day before the DBS procedure,the day of the DBS procedure, 2 days after the DBS procedure

Study Arms (2)

Local anesthesia alone

ACTIVE COMPARATOR

Drug: Local Anesthesia (lidocaine hydrochloride)

Local Anesthesia + Electroacupuncture

EXPERIMENTAL

Procedure: Electroacupuncture; Drug: Local Anesthesia (lidocaine hydrochloride)

Interventions

Electroacupuncture PROCEDURE

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

Local Anesthesia + 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.

Local Anesthesia + Electroacupuncture; Local anesthesia alone

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Centre Hospitalier Universitaire de Nantes

Nantes, 44000, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Electroacupuncture; Anesthesia, Local; Lidocaine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia; Anesthesia, Conduction; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sylvie RAOUL, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 10, 2014
• Study Start: September 3, 2014
• Primary Completion: June 12, 2017
• Study Completion: June 14, 2017
• Last Updated: September 7, 2017

Record last verified: 2017-09

Locations

FR (1)