Parkinson DiseaseNCT03540134
Convection Enhanced Delivery of CSF in DBS for Parkinson's
A study testing Intracerebral Infusion of Autologous Cerebral Spinal Fluid in people with Parkinson Disease, run by Jeff Elias, MD at 1 site in United States.
Trial summary
This study will evaluate safety foremost but also the distribution and initial effectiveness of infusion-enhanced, MRI-guided DBS for patients with medication-refractory, Parkinson's disease Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Intracerebral Infusion of Autologous Cerebral Spinal Fluid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2018to 18 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, age 30 years and older
- Subjects with advanced PD who are scheduled for MRI-guided DBS surgery under general anesthesia
- Subjects who are able and willing to give informed consent and able to attend clinic visits through 6 months
- The target nucleus, GPi or STN, is visible on MRI so that it can be targeted for the study infusion and then for MRI-guided DBS
Who cannot join
- DBS surgery planned in the awake condition with microelectrode recordings and clinical testing
- Spinal pathology not amenable to lumbar puncture
- Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
- Legal incapacity or limited legal capacity as determined by the neuropsychologist
- Are participating or have participated in another clinical trial in the last 30 days
- Any illness that in the investigator's opinion preclude participation in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Convection Enhanced Delivery of Autologous Cerebral Spinal Fluid Improves MRI Visualizations of Basal Ganglion Nuclei During Deep Brain Stimulation Surgery
This study will evaluate safety foremost but also the distribution and initial effectiveness of infusion-enhanced, MRI-guided DBS for patients with medication-refractory, Parkinson's disease
Read the detailed description
This is an open-label, single-arm, pilot study investigating the safety and feasibility of infusion-enhanced, MRI-guided DBS electrode placement. The investigators intend to enroll patients with Parkinson's disease and medically-refractory motor symptoms, who are already planned for MRI-guided DBS electrodes under general anesthesia. The hypothesis of the study is that a convective micro-infusion of autologous CSF will enhance the T2-weighted MRI visualization of the targeted nucleus during image-guided DBS surgery for Parkinson's disease. The investigators will record standard clinical measures of PD at baseline and 6 months following DBS surgery. The study will recruit patients at a rate of approximately one a month and will take less than two years to complete.
- Conditions
- Parkinson Disease
- Being tested
- Intracerebral Infusion of Autologous Cerebral Spinal Fluid
- Keywords
- DBS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracerebral Infusion of Autologous Cerebral Spinal FluidDevice
Unilateral infusion of 0.5 ml autologous CSF before DBS electrode insertion with MRI monitoring
| Study group | Role | What they receive |
|---|---|---|
| Intracerebral Infusion of Autologous CSF | Experimental | All subjects will receive the intracerebral infusion of autologous cerebral spinal fluid (CSF) during their deep brain stimulation (DBS) surgery. The DBS surgery will be performed on the targeted nucleus either bilaterally or unilaterally, as previously determined by a multidisciplinary team of neurology, neurosurgery, and neuropsychology. During unilateral DBS surgery, the targeted nucleus will be infused using convection enhanced delivery (CED). The nondominant side will be infused during a bilateral DBS procedure. Receives: Device: Intracerebral Infusion of Autologous Cerebral Spinal Fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events That Are Related to Treatment
Safety will be determined by an evaluation of the incidence and severity of infusion-related side effects and complications from the first treatment day visit through the 6-month post-treatment time point. All AEs will be reported and categorized by investigators as definitely, probably, possibly, unlikely, or unrelated to the CSF infusion, and/or Parkinson's disease progression. Safety will be assessed by incidence and severity of AEs, including changes in physical examinations and neurological examinations, and the number of discontinuations due to AEs.
Measured: 6 months postoperatively
Secondary outcomes (4)
% Change in Un-medicated UPDRS, Motor Subsection (Part III) From Baseline to 6 Months
The efficacy endpoint will be focused on determining the degree of change in motor symptoms as measured from the in-medicated UPDRS, motor subsection (Part III).
Measured: 6 months postoperatively in comparison to baseline
Vd/Vi Ratio
The ratio of the volume of distribution (Vd) immediately following the infusion (Vi) with intraoperative 1.5T MRI, T2-weighted sequences to the volume of the infusion (Vi) will be calculated. Each volume is measured in microliters (uL). The distribution of the infusion by convective properties in a deep brain human nucleus (GPi or STN) will be determined by calculating the Vd/Vi ratio.
Measured: Day of Surgery
Baseline Levodopa Medication Equivalents (Milligrams)
Measured: Baseline
Change in Quality of Life Assessment With PDQ-39 Questionnaire
The PDQ-39 questionnaire includes 39 quality of life questions rated on a scale of 0-4. 0 indicating least frequent (never) and 4 indicating most frequent (always). The mean change in the sum of the PDQ-39 questionnaire is being reported with a overall score of 0 being the best quality of life and a maximum score of 156 being the worst possible quality of life.
Measured: 6 months postoperatively in comparison to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start13 Feb 2018
- Primary completion18 Dec 2018
- Study completion18 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeff Elias, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeff Elias, MD, University of Virginia
- Investigators
- William J Elias, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540134
- Sponsor's protocol ID
- IRB-HSR #20457
- Status last verified
- Mar 2021
- First submitted
- 11 Apr 2018
- Last updated
- 8 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Moosa S, Bond AE, Wang TR, Farzad F, Asthagiri AR, Elias WJ. Stereotactic and Functional Neurosurgery Convection-Enhanced Delivery of Autologous Cerebrospinal Fluid Enhances Basal Ganglia Visualization during MRI-Guided Deep Brain Stimulation Surgery. Stereotact Funct Neurosurg. 2023;101(2):93-100. doi: 10.1159/000528738. Epub 2023 Feb 1.
PubMed 36724759
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Convection Enhanced Delivery of Autologous Cerebral Spinal Fluid Improves MRI Visualizations of Basal Ganglion Nuclei During Deep Brain Stimulation Surgery
- ClinicalTrials.gov ID
- NCT03540134
- Acronym / sponsor ID
- IRB-HSR #20457
- Conditions
- Parkinson Disease
- Keywords
- DBS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Jeff Elias, MDUniversity, hospital or other
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 30 May 2018 (actual)
- Results
- Posted 8 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate safety foremost but also the distribution and initial effectiveness of infusion-enhanced, MRI-guided DBS for patients with medication-refractory, Parkinson's disease
Detailed description
This is an open-label, single-arm, pilot study investigating the safety and feasibility of infusion-enhanced, MRI-guided DBS electrode placement. The investigators intend to enroll patients with Parkinson's disease and medically-refractory motor symptoms, who are already planned for MRI-guided DBS electrodes under general anesthesia. The hypothesis of the study is that a convective micro-infusion of autologous CSF will enhance the T2-weighted MRI visualization of the targeted nucleus during image-guided DBS surgery for Parkinson's disease. The investigators will record standard clinical measures of PD at baseline and 6 months following DBS surgery. The study will recruit patients at a rate of approximately one a month and will take less than two years to complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracerebral Infusion of Autologous CSF | Experimental | Device: Intracerebral Infusion of Autologous Cerebral Spinal FluidAll subjects will receive the intracerebral infusion of autologous cerebral spinal fluid (CSF) during their deep brain stimulation (DBS) surgery. The DBS surgery will be performed on the targeted nucleus either bilaterally or unilaterally, as previously determined by a multidisciplinary team of neurology, neurosurgery, and neuropsychology. During unilateral DBS surgery, the targeted nucleus will be infused using convection enhanced delivery (CED). The nondominant side will be infused during a bilateral DBS procedure. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women, age 30 years and older
- Subjects with advanced PD who are scheduled for MRI-guided DBS surgery under general anesthesia
- Subjects who are able and willing to give informed consent and able to attend clinic visits through 6 months
- The target nucleus, GPi or STN, is visible on MRI so that it can be targeted for the study infusion and then for MRI-guided DBS
Key exclusion criteria (6 listed)
- DBS surgery planned in the awake condition with microelectrode recordings and clinical testing
- Spinal pathology not amenable to lumbar puncture
- Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
- Legal incapacity or limited legal capacity as determined by the neuropsychologist
- Are participating or have participated in another clinical trial in the last 30 days
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 |
|---|---|---|
| Intracerebral Infusion of Autologous Cerebral Spinal FluidUnilateral infusion of 0.5 ml autologous CSF before DBS electrode insertion with MRI monitoring | Device | Intracerebral Infusion of Autologous CSF |
Primary outcome
Number of Participants With Adverse Events That Are Related to Treatment
Time frame: 6 months postoperatively
Safety will be determined by an evaluation of the incidence and severity of infusion-related side effects and complications from the first treatment day visit through the 6-month post-treatment time point. All AEs will be reported and categorized by investigators as definitely, probably, possibly, unlikely, or unrelated to the CSF infusion, and/or Parkinson's disease progression. Safety will be assessed by incidence and severity of AEs, including changes in physical examinations and neurological examinations, and the number of discontinuations due to AEs.
4 secondary outcomes
% Change in Un-medicated UPDRS, Motor Subsection (Part III) From Baseline to 6 Months
Time frame: 6 months postoperatively in comparison to baseline
Vd/Vi Ratio
Time frame: Day of Surgery
Baseline Levodopa Medication Equivalents (Milligrams)
Time frame: Baseline
Change in Quality of Life Assessment With PDQ-39 Questionnaire
Time frame: 6 months postoperatively in comparison to baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36724759Moosa S, Bond AE, Wang TR, Farzad F, Asthagiri AR, Elias WJ. Stereotactic and Functional Neurosurgery Convection-Enhanced Delivery of Autologous Cerebrospinal Fluid Enhances Basal Ganglia Visualization during MRI-Guided Deep Brain Stimulation Surgery. Stereotact Funct Neurosurg. 2023;101(2):93-100. doi: 10.1159/000528738. Epub 2023 Feb 1.
- Individual participant dataSharing planned: No
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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.
William J Elias, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracerebral Infusion of Autologous Cerebral Spinal Fluid in people with Parkinson Disease, run by Jeff Elias, MD 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 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: finished, as of the sponsor's last update on 8 Apr 2021. 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. 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?
Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Adverse Events That Are Related to Treatment (time frame: 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03540134, which also lists 1 linked publication.
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 8 Apr 2021.