DexmedetomidinePhase 4NCT02982512
Dexmedetomidine on Basal Ganglia Neuronal Activity in Parkinson's Disease
A Phase 4 study testing Dexmedetomidine in people with Dexmedetomidine and Deep Brain Stimulation, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
The implantation of a deep brain stimulator (DBS) is an established option to improve the symptoms of Parkinson's disease (PD) in patients that do not respond adequately to medical therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dexmedetomidine, Deep Brain Stimulation, Parkinson Disease
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2017to Dec 2018
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing placement of DBS for PD in two phases.
- The patient must be of legal age (> 17 years old).
- The patient or his representative has consented to participate in the study.
- The patient should, in the investigator's opinion, be able to cooperate during the procedure.
Who cannot join
- Known liver disease.
- Pregnant or nursing women.
- History of hypersensitivity to dexmedetomidine.
- Heart block (2nd or 3rd degree), without pacemaker.
- Symptomatic hypotension.
- Severe stroke or other neurological deficits that may impair adequate cooperation or observation of the study endpoints.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Clínica Universidad de Navarra
Pamplona, Navarre, 31008
Fernandez J Javier, 948255400 ext. 4717, jjfernanderz@unav.es
Martinez-Simon Antonio, MD, PhD, 948255400 ext. 4813, amartinezs@unav.es
About this study
Official title: Effects of Different Concentrations of Dexmedetomidine on Basal Ganglia Neuronal Activity (Local Field Potentials) in Parkinson's Disease
The implantation of a deep brain stimulator (DBS) is an established option to improve the symptoms of Parkinson's disease (PD) in patients that do not respond adequately to medical therapy. Most centers perform this surgery using a technique that involves microelectrode recording (MER) of neuronal activity for localization of the target nucleus, microstimulation of identified targets, and neurological intraoperative testing in a cooperative patient.
Dexmedetomidine, a α2-adrenergic receptors agonist, is a potent anxiolytic that acts at subcortical areas of the brain without involving GABA receptors. It provides excellent sedation without respiratory depression; also, it has an analgesic component and a predictable hemodynamic response. Low maintenance doses do not appear to interfere with MER. The possible effect of dexmedetomidine in the PD symptoms is still unclear.
Read the detailed description
The implantation of a deep brain stimulator (DBS) is an established option to improve the symptoms of Parkinson's disease (PD) in patients that do not respond adequately to medical therapy. Most centers perform this surgery using a technique that involves microelectrode recording (MER) of neuronal activity for localization of the target nucleus, microstimulation of identified targets, and neurological intraoperative testing in a cooperative patient. This surgery is usually performed in two stages. In the first stage, and under conscious sedation (CS), the target nucleus is localized and the DBS is implanted. About 5 days later, and under general anaesthesia, a programmable pulse generator is implanted and connected to the DBS.
The anesthetic approach varies depending on the institution, ranging from local anesthesia only with monitored care, conscious sedation, and the "asleep-awake" or "asleep-awake-asleep" technique. But sedative drugs can affect the quality of MER by suppressing the firing rate of basal ganglia structures, and alter PD symptoms. Propofol is the drug most commonly used. Its real influence on the quality of MER and PD symptoms is still today controversial. In recent years, some studies have suggested using dexmedetomidine as the main sedative agent for this intervention. Dexmedetomidine, a α2-adrenergic receptors agonist, is a potent anxiolytic that acts at subcortical areas of the brain without involving GABA receptors. It provides excellent sedation without respiratory depression; also, it has an analgesic component and a predictable hemodynamic response. Low maintenance doses do not appear to interfere with MER. The possible effect of dexmedetomidine in the PD symptoms is still unclear. All these characteristics make it a good choice for sedation of PD patients undergoing DBS surgery.
Studying the influence of anesthetic drugs on basal ganglia activity and PD motor symptoms in humans and in a clinical setting is complicated. First, it is difficult to establish a control group to compare effects in different nuclei. There is some data concerning clinical outcomes (clinical symptoms or long term stimulation parameters) but without electrophysiological data. MERs data has been compared between different patients or in the same patient but between contralateral targets. Few studies analyze electrophysiological data with or without one sedative drug in the same target.
- Conditions
- Dexmedetomidine, Deep Brain Stimulation, Parkinson Disease
- Being tested
- Dexmedetomidine
- Keywords
- Potential local fields, Subthalamic neuronal activity
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexdor
Administration of dexmedetomidine a different concetrations
| Study group | Role | What they receive |
|---|---|---|
| Control recording | No intervention | Recording of local field potentials without drugs from the deep brain stimulator |
| Dexmedetomodine recording | Experimental | Recording of local field potentials at different dexmedetomidine concentrations from the deep brain stimulator Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta activity (15-35 Hz)
Global power in the beta band (15-35 Hz) of the electrical oscillatory activity from deep brain structures.
Measured: Control and dexmedetomidine exposure (around 300 min of continuous recording)
Secondary outcomes (1)
Bispectral index scales (a single dimensionless number ranges from 0 - 100)
Weighted sum of several electroencephalographic subparameters, including a time domain, frequency domain, and high order spectral subparameters
Measured: Control and dexmedetomidine exposure (around 300 min of continuous recording)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start1 May 2017
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martinez-Simon Antonio, MD, PhD, Principal investigator, Staff of Anesthesiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982512
- Sponsor's protocol ID
- DEXPAR
- Status last verified
- May 2018
- First submitted
- 28 Nov 2016
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Concentrations of Dexmedetomidine on Basal Ganglia Neuronal Activity (Local Field Potentials) in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02982512
- Acronym / sponsor ID
- DEXPAR
- Conditions
- Dexmedetomidine, Deep Brain Stimulation, Parkinson Disease
- Keywords
- Potential local fields, Subthalamic neuronal activity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 Dec 2016 (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 implantation of a deep brain stimulator (DBS) is an established option to improve the symptoms of Parkinson's disease (PD) in patients that do not respond adequately to medical therapy. Most centers perform this surgery using a technique that involves microelectrode recording (MER) of neuronal activity for localization of the target nucleus, microstimulation of identified targets, and neurological intraoperative testing in a cooperative patient.
Dexmedetomidine, a α2-adrenergic receptors agonist, is a potent anxiolytic that acts at subcortical areas of the brain without involving GABA receptors. It provides excellent sedation without respiratory depression; also, it has an analgesic component and a predictable hemodynamic response. Low maintenance doses do not appear to interfere with MER. The possible effect of dexmedetomidine in the PD symptoms is still unclear.
Detailed description
The implantation of a deep brain stimulator (DBS) is an established option to improve the symptoms of Parkinson's disease (PD) in patients that do not respond adequately to medical therapy. Most centers perform this surgery using a technique that involves microelectrode recording (MER) of neuronal activity for localization of the target nucleus, microstimulation of identified targets, and neurological intraoperative testing in a cooperative patient. This surgery is usually performed in two stages. In the first stage, and under conscious sedation (CS), the target nucleus is localized and the DBS is implanted. About 5 days later, and under general anaesthesia, a programmable pulse generator is implanted and connected to the DBS.
The anesthetic approach varies depending on the institution, ranging from local anesthesia only with monitored care, conscious sedation, and the "asleep-awake" or "asleep-awake-asleep" technique. But sedative drugs can affect the quality of MER by suppressing the firing rate of basal ganglia structures, and alter PD symptoms. Propofol is the drug most commonly used. Its real influence on the quality of MER and PD symptoms is still today controversial. In recent years, some studies have suggested using dexmedetomidine as the main sedative agent for this intervention. Dexmedetomidine, a α2-adrenergic receptors agonist, is a potent anxiolytic that acts at subcortical areas of the brain without involving GABA receptors. It provides excellent sedation without respiratory depression; also, it has an analgesic component and a predictable hemodynamic response. Low maintenance doses do not appear to interfere with MER. The possible effect of dexmedetomidine in the PD symptoms is still unclear. All these characteristics make it a good choice for sedation of PD patients undergoing DBS surgery.
Studying the influence of anesthetic drugs on basal ganglia activity and PD motor symptoms in humans and in a clinical setting is complicated. First, it is difficult to establish a control group to compare effects in different nuclei. There is some data concerning clinical outcomes (clinical symptoms or long term stimulation parameters) but without electrophysiological data. MERs data has been compared between different patients or in the same patient but between contralateral targets. Few studies analyze electrophysiological data with or without one sedative drug in the same target.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control recording | No intervention | –Recording of local field potentials without drugs from the deep brain stimulator |
| Dexmedetomodine recording | Experimental | Drug: DexmedetomidineRecording of local field potentials at different dexmedetomidine concentrations from the deep brain stimulator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing placement of DBS for PD in two phases.
- The patient must be of legal age (> 17 years old).
- The patient or his representative has consented to participate in the study.
- The patient should, in the investigator's opinion, be able to cooperate during the procedure.
Key exclusion criteria (6 listed)
- Known liver disease.
- Pregnant or nursing women.
- History of hypersensitivity to dexmedetomidine.
- Heart block (2nd or 3rd degree), without pacemaker.
- Symptomatic hypotension.
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 |
|---|---|---|
| DexmedetomidineAlso: DexdorAdministration of dexmedetomidine a different concetrations | Drug | Dexmedetomodine recording |
Primary outcome
Beta activity (15-35 Hz)
Time frame: Control and dexmedetomidine exposure (around 300 min of continuous recording)
Global power in the beta band (15-35 Hz) of the electrical oscillatory activity from deep brain structures.
1 secondary outcome
Bispectral index scales (a single dimensionless number ranges from 0 - 100)
Time frame: Control and dexmedetomidine exposure (around 300 min of continuous recording)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
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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.
Martinez-Simon Antonio, MD, PhD principal investigator
Staff of Anesthesiology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine in people with Dexmedetomidine and Deep Brain Stimulation, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 May 2018. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martinez-Simon Antonio, MD, PhD (+34 948255400 ext. 4813, amartinezs@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beta activity (15-35 Hz) (time frame: Control and dexmedetomidine exposure (around 300 min of continuous recording)). 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 11 May 2018.