Deep Brain StimulationNCT06191874
Evaluation of Advanced Imaging and Visualization for Clinical Deep Brain Stimulation
An observational study of Deep Brain Stimulation, run by Duke University at 1 site in United States.
Trial summary
The objective of this project is to evaluate next generation visualization tools and surgical targeting models for clinical deep brain stimulation (DBS). This study will evaluate the performance of HoloDBS software in comparison to the current standard (SOC) clinical planning tools to prepare for DBS surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Brain Stimulation
- What is being tested?
- Standard-of-care (SOC) surgery plan and HoloDBS hypothetical surgery plan
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 29 May 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Parkinson's disease scheduled for Deep Brain Stimulation Surgery
Who may be able to join
- age 18 years and over
- meeting qualification for deep brain stimulation for Parkinson's disease with one or more of medication refractory tremor, motor fluctuations despite medication optimization, or levodopa responsiveness but limited by medication induced adverse effects (nausea, dystonia, dyskinesia for example).
Who cannot join
- consideration of alternate diagnosis to Parkinson disease
- high risk medical comorbidities which would make the patient not a candidate for surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Advanced Imaging and Visualization to Clinical Deep Brain Stimulation
The objective of this project is to evaluate next generation visualization tools and surgical targeting models for clinical deep brain stimulation (DBS).
This study will evaluate the performance of HoloDBS software in comparison to the current standard (SOC) clinical planning tools to prepare for DBS surgery. The investigators hypothesize that HoloDBS will provide more detailed and anatomically useful information to the neurosurgeon and neurologist than the current clinical standard.
The study team reviews electronic medical records (EMR) from patients who are undergoing DBS surgery. There are no study visits involved in this study as only data from standard clinical care will be used. All study activities are executed by the study team and there are no interventions.
- Conditions
- Deep Brain Stimulation
- Being tested
- Standard-of-care (SOC) surgery plan, HoloDBS hypothetical surgery plan
- Keywords
- DBS, Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard-of-care (SOC) surgery planOther
Use of SOC clinical planning tools to prepare for DBS (deep brain stimulation) surgery
HoloDBS hypothetical surgery planOther
Use of next generation visualization tools and surgical targeting models to hypothetically prepare for DBS (deep brain stimulation) surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgery planning by SOC methods, then by HoloDBS | Standard-of-care (SOC) surgery plan is built before the HoloDBS hypothetical surgery plan Receives: Other: Standard-of-care (SOC) surgery plan; Other: HoloDBS hypothetical surgery plan | |
| Surgery planning by HoloDBS, then by SOC methods | HoloDBS hypothetical surgery plan is built before the standard-of-care (SOC) surgery plan Receives: Other: Standard-of-care (SOC) surgery plan; Other: HoloDBS hypothetical surgery plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Between the Actual Post-operative Location of the DBS Electrode and the Planned Location
Comparison of the post-operative position of the DBS electrode to the location that was defined in the standard-of-care plan and the HoloDBS plan. The distance was calculated for each hemisphere for each participant as the distance between the actual post-operative electrode location and the location defined in the SOC plan (indicated as SOC) and the distance between the actual post-operative electrode location and the location defined in the HoloDBS plan (indicated as HoloDBS).
Measured: 1 month after surgery
Secondary outcomes (1)
Percentage of Physicians Who Reply 'Yes' to the Question, 'Was the Additional Data Available in the HoloDBS Application Valuable in Defining Your Theoretical Optimal Electrode Position?'
Open-ended discussion with neurosurgery-neurology team. Physicians were not considered enrolled.
Measured: 6 months and 1 year after study starts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Mar 2024
- Primary completion29 May 2025
- Study completion29 May 2025
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.
- Other trials for Deep Brain StimulationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191874
- Sponsor's protocol ID
- Pro00113490
- Other IDs
- R37NS116079
- Status last verified
- Jun 2026
- First submitted
- 6 Dec 2023
- Last updated
- 24 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Advanced Imaging and Visualization to Clinical Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT06191874
- Acronym / sponsor ID
- Pro00113490
- Conditions
- Deep Brain Stimulation
- Keywords
- DBS, Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Posted 24 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this project is to evaluate next generation visualization tools and surgical targeting models for clinical deep brain stimulation (DBS).
This study will evaluate the performance of HoloDBS software in comparison to the current standard (SOC) clinical planning tools to prepare for DBS surgery. The investigators hypothesize that HoloDBS will provide more detailed and anatomically useful information to the neurosurgeon and neurologist than the current clinical standard.
The study team reviews electronic medical records (EMR) from patients who are undergoing DBS surgery. There are no study visits involved in this study as only data from standard clinical care will be used. All study activities are executed by the study team and there are no interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery planning by SOC methods, then by HoloDBS | – | Other: Standard-of-care (SOC) surgery plan, Other: HoloDBS hypothetical surgery planStandard-of-care (SOC) surgery plan is built before the HoloDBS hypothetical surgery plan |
| Surgery planning by HoloDBS, then by SOC methods | – | Other: Standard-of-care (SOC) surgery plan, Other: HoloDBS hypothetical surgery planHoloDBS hypothetical surgery plan is built before the standard-of-care (SOC) surgery plan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease scheduled for Deep Brain Stimulation Surgery
Key inclusion criteria (2 listed)
- age 18 years and over
- meeting qualification for deep brain stimulation for Parkinson's disease with one or more of medication refractory tremor, motor fluctuations despite medication optimization, or levodopa responsiveness but limited by medication induced adverse effects (nausea, dystonia, dyskinesia for example).
Key exclusion criteria (2 listed)
- consideration of alternate diagnosis to Parkinson disease
- high risk medical comorbidities which would make the patient not a candidate for surgery.
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 |
|---|---|---|
| Standard-of-care (SOC) surgery planUse of SOC clinical planning tools to prepare for DBS (deep brain stimulation) surgery | Other | Surgery planning by HoloDBS, then by SOC methods, Surgery planning by SOC methods, then by HoloDBS |
| HoloDBS hypothetical surgery planUse of next generation visualization tools and surgical targeting models to hypothetically prepare for DBS (deep brain stimulation) surgery | Other | Surgery planning by HoloDBS, then by SOC methods, Surgery planning by SOC methods, then by HoloDBS |
Primary outcome
Distance Between the Actual Post-operative Location of the DBS Electrode and the Planned Location
Time frame: 1 month after surgery
Comparison of the post-operative position of the DBS electrode to the location that was defined in the standard-of-care plan and the HoloDBS plan. The distance was calculated for each hemisphere for each participant as the distance between the actual post-operative electrode location and the location defined in the SOC plan (indicated as SOC) and the distance between the actual post-operative electrode location and the location defined in the HoloDBS plan (indicated as HoloDBS).
1 secondary outcome
Percentage of Physicians Who Reply 'Yes' to the Question, 'Was the Additional Data Available in the HoloDBS Application Valuable in Defining Your Theoretical Optimal Electrode Position?'
Time frame: 6 months and 1 year after study starts
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Deep Brain Stimulation
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Cerebellar DBS in SCA1 and SCA3 Study
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Brain Stimulation, run by Duke 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 2 inclusion and 2 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 24 Jul 2026. 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 24 Jul 2026). 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?
Distance Between the Actual Post-operative Location of the DBS Electrode and the Planned Location (time frame: 1 month after surgery). 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 24 Jul 2026.