Parkinson's DiseaseNCT02731365
Concurrent DBS Local Field Potential Analysis and Stimulation in a Closed-Loop Neuromodulation Device
A study testing Activa PC+S in people with Parkinson's Disease, run by Vibhor Krishna at 1 site in United States.
Trial summary
The purpose of this clinical study is to allow the investigation of local field potential (LFP) signals in patients treated with DBS of the STN. This study will identify common LFP biomarkers observed as a function of disease symptoms, medication effect, fluctuations in disease, and changes resulting from adjustments… Read more about this study
- Who is it for?
- Ages 22 to 90 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Activa PC+S
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Nov 2016
- Phase
- Interventional
- 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 22 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who are candidates for DBS surgery.
- Age 22-90 years of age
- Participant is willing to comply with all follow-up evaluations at the specified study time points.
- Participant is able to provide informed consent prior to enrollment in the study.
- The participant is fluent in English.
Who cannot join
- Significant cognitive impairment or dementia.
- Uncontrolled depression, anxiety or other mood disorder.
- Medical contraindications for general anesthesia, craniotomy, or DBS surgery.
- Diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months.
- Condition requiring diathermy after DBS implantation.
- Subjects with any type of destruction and/or damage to the STN as determined by brain imaging.
Show all 18Show fewer
- Co-morbid conditions that would interfere with study activities or response to treatment, which may include:
- Life expectancy < 3 years
- Severe Chronic pulmonary disease
- Intractable seizure disorders
- Local, systemic acute or chronic infectious illness
- Life threatening cardiac arrhythmias
- Severe collagen vascular disorder
- Kidney failure or other major organ systems failures
- History of a neurological ablation procedure.
- Labeled contraindication for MRI.
- History of hemorrhagic stroke.
- History of HIV infection or ongoing chronic infection (such as tuberculosis). Participation in another FDA device or medication trial that would interfere with the current study.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center - Center for Neuromodulation
Columbus, Ohio, 43210
About this study
Official title: Concurrent Deep Brain Stimulation (DBS) Local Field Potential Analysis and Stimulation in a Closed-Loop Neuromodulation Device
The purpose of this clinical study is to allow the investigation of local field potential (LFP) signals in patients treated with DBS of the STN. This study will identify common LFP biomarkers observed as a function of disease symptoms, medication effect, fluctuations in disease, and changes resulting from adjustments from current standard practices of DBS programming. The data collected and LFP markers identified will serve as guidelines for future stimulation predicted programming.
Read the detailed description
The goals of this study are to evaluate local field potentials (LFP) and associated beta, gamma and other band oscillations and their correlation with disease pathophysiology and clinical status of the patients, and to potentially determine a more objective biomarker of response to deep brain stimulation (DBS) treatment. This study aims to find evidence that changes in the power and coherence of the beta and gamma bands can be consistently linked to DBS adjustment and associated clinical effects. This approach can be of significant potential benefit to provide a foundation for closed loop DBS therapy in patients with continuous DBS adjustments.
This study will use a novel bi-directional neural interface system that can chronically and simultaneously record, sense, process and telemeter LFP signals from DBS electrode (Rouse et al. 2011) to study the stability and subsequent change to LFP linked to the clinical state relevant to the present disorder, and DBS stimulation at rest and during motor and cognitive tasks. This investigation will be conducted at the Ohio State University.
- Conditions
- Parkinson's Disease
- Being tested
- Activa PC+S
- Keywords
- 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.
Activa PC+SDevice
The Activa PC+S is a newly developed Medtronic DBS implantable system and is available for use in clinical research. This system has a mechanism for both sensing of LFP and the ability to provide deep brain stimulation therapy. The sensing capabilities are controllable with data management using a clinician sensing tablet programmer that has a USB extension allowing for telemetry to an encrypted, locked computer.
| Study group | Role | What they receive |
|---|---|---|
| DBS LFP Activa PC+S | Experimental | The study aims at testing a slightly modified device (battery) that is similar to the approved system that has the potential of offering future patients a closed loop system with automatic adjustments of stimulation. The purpose of this clinical study is to allow the investigation of local field potential (LFP) signals in patients treated with DBS of the STN. This study will identify common LFP biomarkers observed as a function of disease symptoms, medication effect, fluctuations in disease, and changes resulting from adjustments from current standard practices of DBS programming. Receives: Device: Activa PC+S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify and record LFP
The association between local field potential (LFP) signals in individuals who have undergone deep brain stimulation (DBS) of the subthalamic nucleus (STN) and successful completion of a cursor drive motor task.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startFeb 2015
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: Study stopped to await new generation of device anticipated to be released 2018.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vibhor Krishna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vibhor Krishna, Ohio State University
- Investigators
- Ali Rezai, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731365
- Sponsor's protocol ID
- 2014H0423
- Status last verified
- Nov 2016
- First submitted
- 13 Oct 2015
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Deep Brain Stimulation (DBS) Local Field Potential Analysis and Stimulation in a Closed-Loop Neuromodulation Device
- ClinicalTrials.gov ID
- NCT02731365
- Acronym / sponsor ID
- 2014H0423
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study stopped to await new generation of device anticipated to be released 2018.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vibhor KrishnaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 7 Apr 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 purpose of this clinical study is to allow the investigation of local field potential (LFP) signals in patients treated with DBS of the STN. This study will identify common LFP biomarkers observed as a function of disease symptoms, medication effect, fluctuations in disease, and changes resulting from adjustments from current standard practices of DBS programming. The data collected and LFP markers identified will serve as guidelines for future stimulation predicted programming.
Detailed description
The goals of this study are to evaluate local field potentials (LFP) and associated beta, gamma and other band oscillations and their correlation with disease pathophysiology and clinical status of the patients, and to potentially determine a more objective biomarker of response to deep brain stimulation (DBS) treatment. This study aims to find evidence that changes in the power and coherence of the beta and gamma bands can be consistently linked to DBS adjustment and associated clinical effects. This approach can be of significant potential benefit to provide a foundation for closed loop DBS therapy in patients with continuous DBS adjustments.
This study will use a novel bi-directional neural interface system that can chronically and simultaneously record, sense, process and telemeter LFP signals from DBS electrode (Rouse et al. 2011) to study the stability and subsequent change to LFP linked to the clinical state relevant to the present disorder, and DBS stimulation at rest and during motor and cognitive tasks. This investigation will be conducted at the Ohio State University.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBS LFP Activa PC+S | Experimental | Device: Activa PC+SThe study aims at testing a slightly modified device (battery) that is similar to the approved system that has the potential of offering future patients a closed loop system with automatic adjustments of stimulation. The purpose of this clinical study is to allow the investigation of local field potential (LFP) signals in patients treated with DBS of the STN. This study will identify common LFP biomarkers observed as a function of disease symptoms, medication effect, fluctuations in disease, and changes resulting from adjustments from current standard practices of DBS programming. |
Who may qualify
- Ages
- 22 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants who are candidates for DBS surgery.
- Age 22-90 years of age
- Participant is willing to comply with all follow-up evaluations at the specified study time points.
- Participant is able to provide informed consent prior to enrollment in the study.
- The participant is fluent in English.
Key exclusion criteria (18 listed)
- Significant cognitive impairment or dementia.
- Uncontrolled depression, anxiety or other mood disorder.
- Medical contraindications for general anesthesia, craniotomy, or DBS surgery.
- Diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months.
- Condition requiring diathermy after DBS implantation.
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 |
|---|---|---|
| Activa PC+SThe Activa PC+S is a newly developed Medtronic DBS implantable system and is available for use in clinical research. This system has a mechanism for both sensing of LFP and the ability to provide deep brain stimulation therapy. The sensing capabilities are controllable with data management using a clinician sensing tablet programmer that has a USB extension allowing for telemetry to an encrypted, locked computer. | Device | DBS LFP Activa PC+S |
Primary outcome
Identify and record LFP
Time frame: 18 months
The association between local field potential (LFP) signals in individuals who have undergone deep brain stimulation (DBS) of the subthalamic nucleus (STN) and successful completion of a cursor drive motor task.
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 17 Nov 2016.
- Individual participant dataSharing planned: No
Related trials for Parkinson's Disease
Recruiting
OCT-Angiography and Adaptive Optics in Patients With Memory Impairment
Amnesia, Alzheimer Disease
Not yet recruitingPhase 2
Estimates of the Efficacy of Talineuren (TLN) and Placebo in Patients With Parkinson Disease
Parkinson Disease
RecruitingPhase 3
A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
Carcinoma, Non-Small-Cell Lung
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
Active, not recruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
Parkinson&Amp;#39;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. This study is not recruiting at the moment.
Ali Rezai, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activa PC+S in people with Parkinson's Disease, run by Vibhor Krishna 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 5 inclusion and 18 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 17 Nov 2016. 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?
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?
Identify and record LFP (time frame: 18 months). 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 Nov 2016; AzTrials last refreshed its copy on 31 Oct 2026.