An interventional study of Electroacupuncture and Local Anesthesia (lidocaine hydrochloride) in Parkinson's Disease, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2017-09-07.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Supportive care
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
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Drug: Local Anesthesia (lidocaine hydrochloride)
Procedure: Electroacupuncture · Drug: Local Anesthesia (lidocaine hydrochloride)
Acupuncture will be performed using an electrical stimulator (generating electrical stimulation) for electroacupuncture.
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.
Patient comfort, judged by "Edmonton Symptom Assessment System" scale (ESAS)
Time frame: The day of the DBS procedure
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
Drug consumption
Time frame: The day of the DBS procedure, 2 days after the DBS procedure
Anesthesia monitoring parameters: heart rate, blood pressure, pulse oximetry
Composite measure
Time frame: The day of the DBS procedure, 2 days after the DBS procedure
Adverse effects
Time frame: The day before the DBS procedure,the day of the DBS procedure, 2 days after the DBS procedure
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Nantes University Hospital