Parkinson's DiseaseACUplusNCT02236260
Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation
A study testing Electroacupuncture and Local Anesthesia (lidocaine hydrochloride) in people with Parkinson's Disease, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Electroacupuncture and Local Anesthesia (lidocaine hydrochloride)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2014to 14 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- History of motion sickness
- Unstabilized psychiatric disorders
- Impaired cognitive functions
- Pregnancy
- Breastfeeding
- Minors
- Major under a legal protection regime
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- Electroacupuncture, Local Anesthesia (lidocaine hydrochloride)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Local anesthesia alone | Active comparator | Not described Receives: Drug: Local Anesthesia (lidocaine hydrochloride) |
| Local Anesthesia + Electroacupuncture | Experimental | Not described Receives: Procedure: Electroacupuncture; Drug: Local Anesthesia (lidocaine hydrochloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient comfort, judged by "Edmonton Symptom Assessment System" scale (ESAS)
Measured: The day of the DBS procedure
Secondary outcomes (4)
Patient anxiety, judged by Hamilton anxiety scale (HAMA)
Measured: The day before the DBS procedure, the day of the DBS procedure, 2 days after the DBS procedure
Drug consumption
Measured: The day of the DBS procedure, 2 days after the DBS procedure
Anesthesia monitoring parameters: heart rate, blood pressure, pulse oximetry
Composite measure
Measured: The day of the DBS procedure, 2 days after the DBS procedure
Adverse effects
Measured: The day before the DBS procedure,the day of the DBS procedure, 2 days after the DBS procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study start3 Sep 2014
- Primary completion12 Jun 2017
- Study completion14 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie RAOUL, MD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236260
- Sponsor's protocol ID
- RC14_0060
- Acronym
- ACUplus
- Status last verified
- Sep 2017
- First submitted
- 29 Aug 2014
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02236260
- Acronym / sponsor ID
- ACUplus / RC14_0060
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 3 Sep 2014 (actual)
- Primary completion
- 12 Jun 2017 (actual)
- Study completion
- 14 Jun 2017 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local anesthesia alone | Active comparator | Drug: Local Anesthesia (lidocaine hydrochloride) |
| Local Anesthesia + Electroacupuncture | Experimental | Procedure: Electroacupuncture, Drug: Local Anesthesia (lidocaine hydrochloride) |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- Patients who are >= 75 years
- History of intolerance to acupuncture
- Contraindications to local anesthesia
- Respiratory problems (asthma, COPD, ...)
- Holder of an implanted pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureAcupuncture will be performed using an electrical stimulator (generating electrical stimulation) for electroacupuncture. | Procedure or surgery | Local Anesthesia + Electroacupuncture |
| 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. | Drug | Local Anesthesia + Electroacupuncture, Local anesthesia alone |
Primary outcome
Patient comfort, judged by "Edmonton Symptom Assessment System" scale (ESAS)
Time frame: The day of the DBS procedure
4 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie RAOUL, MD principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture and Local Anesthesia (lidocaine hydrochloride) in people with Parkinson's Disease, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient comfort, judged by "Edmonton Symptom Assessment System" scale (ESAS) (time frame: The day of the DBS procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2017.