Parkinson's DiseasePhase 2/3NCT00608231
Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation
A Phase 2/3 study testing Dexmedetomidine Hydrochloride Infusion and Normal Saline in people with Parkinson's Disease and Essential Tremor, run by Vanderbilt University at 1 site in United States.
Trial summary
To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery has no significant effect on electrophysiological parameters of DBS micro-electrode recordings Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease, Essential Tremor, Dystonia
- What is being tested?
- Dexmedetomidine Hydrochloride Infusion and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jan 2012
- Phase
- Phase 2/3
- 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
- Any patient who has agreed to undergo DBS implantation.
Who cannot join
- Patients who fail recommendation for DBS surgery discussed in Vanderbilt University Movement Disorder Clinical Conference.
- Patients not consented for DBS surgery.
- Patients or legal guardians not able to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery has no significant effect on electrophysiological parameters of DBS micro-electrode recordings
Read the detailed description
Deep brain stimulator (DBS) implants are used in the treatment of medically refractory movement disorders such as Parkinson's disease, essential tremor and dystonia. Because of the uniqueness of each individual brain, the surgery to implant a DBS electrode requires detailed anatomic and physiological information for each patient. The anatomic data is obtained before surgery via a Magnetic Resonance Imaging (MRI) scan of the patient's brain. Physiological data is obtained during the operation via micro-electrode recording of the patient's brain and neurological examination of the patient. Therefore, DBS surgery can be uncomfortable to patients, as it can be very time consuming and requires the patient to be awake and attentive.
The specific aims of this project are:
- To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery has no significant effect on electrophysiological parameters of DBS micro-electrode recordings.
- To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery have no significant effects on neurological findings and/or patient cooperation during neurological examination.
- Conditions
- Parkinson's Disease, Essential Tremor, Dystonia
- Being tested
- Dexmedetomidine Hydrochloride Infusion, Normal Saline
- Medical subject headings
- Parkinson Disease, Essential Tremor, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Hydrochloride InfusionDrug
Also called Precedex
Dexmedetomidine Hydrochloride Infusion(0.5-1.0 mg/kg)intravenous over 10 minutes with dose adjustment for goal Richmond Agitation and Sedation Scale of -1 During deep brain stimulator implantation surgery
Normal SalineDrug
Also called Placebo control
Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery
| Study group | Role | What they receive |
|---|---|---|
| PD-STN | Experimental | Parkinson's Disease -- STN target Receives: Drug: Dexmedetomidine Hydrochloride Infusion |
| PD - GPi | Experimental | Parkinson's Disease -- GPi target Receives: Drug: Dexmedetomidine Hydrochloride Infusion |
| ET - VIM | Experimental | Essential Tremor -- VIM target Receives: Drug: Dexmedetomidine Hydrochloride Infusion |
| Dystonia - GPi | Experimental | Dystonia -- GPi target Receives: Drug: Dexmedetomidine Hydrochloride Infusion |
| PD - STN Control | Placebo comparator | Parkinson's Disease -- STN target Receives: Drug: Normal Saline |
| PD - GPi Control | Placebo comparator | Parkinson's Disease -- GPi target Receives: Drug: Normal Saline |
| ET - VIM Control | Placebo comparator | Essential Tremor -- VIM target Receives: Drug: Normal Saline |
| Dystonia - GPi Control | Placebo comparator | Dystonia -- GPi target Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Micro-electrode Recordings
Measured: Intra-operative
Secondary outcomes (1)
Neurological Exam Findings
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Intraoperative recording could not be maintained for required period
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Neimat, Vanderbilt University
- Investigators
- Joseph Neimat, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608231
- Sponsor's protocol ID
- 070666
- Status last verified
- Jun 2014
- First submitted
- 7 Jan 2008
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT00608231
- Acronym / sponsor ID
- 070666
- Conditions
- Parkinson's Disease, Essential Tremor, Dystonia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Intraoperative recording could not be maintained for required period
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 6 Feb 2008 (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.
To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery has no significant effect on electrophysiological parameters of DBS micro-electrode recordings
Detailed description
Deep brain stimulator (DBS) implants are used in the treatment of medically refractory movement disorders such as Parkinson's disease, essential tremor and dystonia. Because of the uniqueness of each individual brain, the surgery to implant a DBS electrode requires detailed anatomic and physiological information for each patient. The anatomic data is obtained before surgery via a Magnetic Resonance Imaging (MRI) scan of the patient's brain. Physiological data is obtained during the operation via micro-electrode recording of the patient's brain and neurological examination of the patient. Therefore, DBS surgery can be uncomfortable to patients, as it can be very time consuming and requires the patient to be awake and attentive.
The specific aims of this project are:
- To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery has no significant effect on electrophysiological parameters of DBS micro-electrode recordings.
- To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery have no significant effects on neurological findings and/or patient cooperation during neurological examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| PD-STN | Experimental | Drug: Dexmedetomidine Hydrochloride InfusionParkinson's Disease -- STN target |
| PD - GPi | Experimental | Drug: Dexmedetomidine Hydrochloride InfusionParkinson's Disease -- GPi target |
| ET - VIM | Experimental | Drug: Dexmedetomidine Hydrochloride InfusionEssential Tremor -- VIM target |
| Dystonia - GPi | Experimental | Drug: Dexmedetomidine Hydrochloride InfusionDystonia -- GPi target |
| PD - STN Control | Placebo comparator | Drug: Normal SalineParkinson's Disease -- STN target |
| PD - GPi Control | Placebo comparator | Drug: Normal SalineParkinson's Disease -- GPi target |
| ET - VIM Control | Placebo comparator | Drug: Normal SalineEssential Tremor -- VIM target |
| Dystonia - GPi Control | Placebo comparator | Drug: Normal SalineDystonia -- GPi target |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient who has agreed to undergo DBS implantation.
Key exclusion criteria (3 listed)
- Patients who fail recommendation for DBS surgery discussed in Vanderbilt University Movement Disorder Clinical Conference.
- Patients not consented for DBS surgery.
- Patients or legal guardians not able to provide informed consent.
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 |
|---|---|---|
| Dexmedetomidine Hydrochloride InfusionAlso: PrecedexDexmedetomidine Hydrochloride Infusion(0.5-1.0 mg/kg)intravenous over 10 minutes with dose adjustment for goal Richmond Agitation and Sedation Scale of -1 During deep brain stimulator implantation surgery | Drug | Dystonia - GPi, ET - VIM, PD - GPi, PD-STN |
| Normal SalineAlso: Placebo controlNormal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery | Drug | Dystonia - GPi Control, ET - VIM Control, PD - GPi Control, PD - STN Control |
Primary outcome
Micro-electrode Recordings
Time frame: Intra-operative
1 secondary outcome
Neurological Exam Findings
Time frame: Intra-operative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
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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.
Joseph Neimat, M.D. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine Hydrochloride Infusion and Normal Saline in people with Parkinson's Disease and Essential Tremor, run by Vanderbilt University at 1 site in United States.
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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 1 Jul 2014. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Micro-electrode Recordings (time frame: Intra-operative). 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 1 Jul 2014.