Parkinson Disease, IdiopathicNCT06872203
LFP Sensing From Directional Leads in the Acute Clinical Setting
An observational study of Parkinson Disease, Idiopathic and Parkinson Disease, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more about the optimal way to program the Medtronic Deep Brain Stimulation system in patients with Parkinson's Disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease, Idiopathic, Parkinson Disease
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PD patients undergoing implantation of Medtronic DBS system; Sensight(TM) lead and Percept (TM) battery
Inclusion Criteria: Parkinson's Disease, scheduled to undergo bilateral subthalamic nucleus (STN) Deep Brain Stimulation (DBS) surgery at the University of Colorado Hospital, chosen to have a Medtronic Deep Brain Stimulation system implanted (Percept™ battery \& SenSight™ electrode). Parkinson's Disease causes upper extremity bradykinesia (slowness of movement) with a MDS-UPDRS1score of 2 or higher when you are off your PD medications.
-
Exclusion Criteria: Dementia or other psychological disorders that precludes consent to participate. Inability to follow testing procedures as determined by the study doctor. Inability to be OFF medication for study visits. Existing implanted Deep Brain Stimulation system or implanted cardiac device. Unilateral Medtronic DBS system, or programming not occurring at the University of Colorado Hospital.
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: LFP Sensing From Directional Leads and Associated Clinical Outcomes in the Acute Clinical Setting
This study plans to learn more about the optimal way to program the Medtronic Deep Brain Stimulation system in patients with Parkinson's Disease.
Read the detailed description
The investigators will conduct a prospective study in patients with Parkinson's disease (PD) implanted with standard of care, subthalamic nucleus (STN) deep brain stimulation (DBS) electrodes, to test whether monopolar sensing of the maximal power in the beta frequency range (in STN) predicts the optimal therapeutic stimulation setting for alleviation of PD motor symptoms. Participants in this study will have been implanted with a Medtronic DBS system consisting of a PerceptTM PC neurostimulator (battery) and SenSight™ DBS leads (implanted electrodes) with BrainSenseTM technology. The DBS surgery is a standard of care procedure, and no alteration of the surgical plan will occur for research purposes . The ranked response between the clinical profile (therapeutic benefit and adverse effects) and beta power will be compared for all electrical contacts on the implanted electrode. Additional analysis of monopolar sensing compared to differential bipolar sensing, location/distance and volume of neural activation (VNA) of optimal contacts identified by beta power or therapeutic window will be estimated with respect to the STN.
Aim 1- Determine whether monopolar sensing of beta power, in the outpatient clinic setting, will predict the optimal therapeutic contact for electrical stimulation of the STN.
Aim 2 - Long Term Follow Up (>12 months) of the same consented study participants to determine the stability of the beta power to determine the optimal contact for therapeutic stimulation.
- Conditions
- Parkinson Disease, Idiopathic, Parkinson Disease
- Being tested
- Deep brain stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationDevice
Deep Brain Stimulation programming
| Study group | Role | What they receive |
|---|---|---|
| PD patient | PD patient after receiving a Medtronic DBS implant. Receives: Device: Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare beta frequency power to the TW of each contact.
Contacts will be ranked from highest to lowest in beta frequency power and compared to the rankings of the TW from largest to least. It is hypothesized that there will NOT be a statistically significant difference between the ranks for beta power and TW. This would indicate that the contact with the highest beta frequency power also had the largest TW and the converse also being evident.
Measured: 2 study visits of 4 hours each, one week apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start1 Jun 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease, IdiopathicStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John A Thompson, PhD, Study director, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872203
- Sponsor's protocol ID
- 21-4938
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LFP Sensing From Directional Leads and Associated Clinical Outcomes in the Acute Clinical Setting
- ClinicalTrials.gov ID
- NCT06872203
- Acronym / sponsor ID
- 21-4938
- Conditions
- Parkinson Disease, Idiopathic, Parkinson Disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Mar 2025 (actual)
- 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.
This study plans to learn more about the optimal way to program the Medtronic Deep Brain Stimulation system in patients with Parkinson's Disease.
Detailed description
The investigators will conduct a prospective study in patients with Parkinson's disease (PD) implanted with standard of care, subthalamic nucleus (STN) deep brain stimulation (DBS) electrodes, to test whether monopolar sensing of the maximal power in the beta frequency range (in STN) predicts the optimal therapeutic stimulation setting for alleviation of PD motor symptoms. Participants in this study will have been implanted with a Medtronic DBS system consisting of a PerceptTM PC neurostimulator (battery) and SenSight™ DBS leads (implanted electrodes) with BrainSenseTM technology. The DBS surgery is a standard of care procedure, and no alteration of the surgical plan will occur for research purposes . The ranked response between the clinical profile (therapeutic benefit and adverse effects) and beta power will be compared for all electrical contacts on the implanted electrode. Additional analysis of monopolar sensing compared to differential bipolar sensing, location/distance and volume of neural activation (VNA) of optimal contacts identified by beta power or therapeutic window will be estimated with respect to the STN.
Aim 1- Determine whether monopolar sensing of beta power, in the outpatient clinic setting, will predict the optimal therapeutic contact for electrical stimulation of the STN.
Aim 2 - Long Term Follow Up (>12 months) of the same consented study participants to determine the stability of the beta power to determine the optimal contact for therapeutic stimulation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD patient | – | Device: Deep brain stimulationPD patient after receiving a Medtronic DBS implant. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PD patients undergoing implantation of Medtronic DBS system; Sensight(TM) lead and Percept (TM) battery
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 |
|---|---|---|
| Deep brain stimulationDeep Brain Stimulation programming | Device | PD patient |
Primary outcome
To compare beta frequency power to the TW of each contact.
Time frame: 2 study visits of 4 hours each, one week apart.
Contacts will be ranked from highest to lowest in beta frequency power and compared to the rankings of the TW from largest to least. It is hypothesized that there will NOT be a statistically significant difference between the ranks for beta power and TW. This would indicate that the contact with the highest beta frequency power also had the largest TW and the converse also being evident.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease, Idiopathic
Not yet recruitingObservational study
Longitudinal Observation of Neurodegeneration in Parkinson's Disease Using Molecular Imaging and Blood Biomarkers
Idiopathic Parkinson Disease
Not yet recruiting
Non-invasive Vagus Nerve Stimulation for Parkinson's Disease
Idiopathic Parkinson Disease
RecruitingPhase 2
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Parkinson Disease, Parkinson
Recruiting
MediPD: An Online Mediterranean Diet Program for People Living With Parkinson's Disease
Parkinson Disease, Idiopathic
Recruiting
Ginger-PD: Ginger as a Modifier of Ghrelin Levels and Gut Function in Parkinson's Disease
REM Sleep Behavior Disorder, Parkinson s Disease
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.
John A Thompson, PhD study director
University of Colorado, Denver
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 Parkinson Disease, Idiopathic and Parkinson Disease, run by University of Colorado, Denver 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?
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: enrolling by invitation, as of the sponsor's last update on 17 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
To compare beta frequency power to the TW of each contact. (time frame: 2 study visits of 4 hours each, one week apart.). 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 17 Mar 2025.