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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02236260 |
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Date of registration:
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29/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation
ACUplus |
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Scientific title:
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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. |
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Date of first enrolment:
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September 3, 2014 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02236260 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Sylvie RAOUL, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nantes University Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
74 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Local Anesthesia (lidocaine hydrochloride)
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Procedure: Electroacupuncture
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Primary Outcome(s)
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Patient comfort, judged by "Edmonton Symptom Assessment System" scale (ESAS)
[Time Frame: The day of the DBS procedure]
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Secondary Outcome(s)
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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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Drug consumption
[Time Frame: The day of the DBS procedure, 2 days after the DBS procedure]
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Anesthesia monitoring parameters: heart rate, blood pressure, pulse oximetry
[Time Frame: The day of the DBS procedure, 2 days after the DBS procedure]
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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]
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Secondary ID(s)
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RC14_0060
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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