Parkinson DiseaseNCT03446833
LFP Beta aDBS Feasibility Study
A study testing The LFP Beta aDBS System in people with Parkinson Disease, run by MedtronicNeuro at 2 sites in United States.
Trial summary
The purpose of this study is to use local field potentials as control signals for adjusting DBS stimulation settings under varying patient states and to assess patient outcomes. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- The LFP Beta aDBS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Sep 2018to 6 Feb 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Preoperative:
- Subject has the ability to understand and provide written informed consent for participation in the study prior to the study-related procedures being conducted
- Subject with levodopa-responsive PD of at least 4 years' duration, with symptoms not adequately controlled with medication, including individuals with motor complications of recent onset (from 4 months to 3 years) or with motor complications of longer-standing duration, and who are eligible for bilateral STN DBS surgery
- Subject is ≥ 22 years of age at time of informed consent
- Subject is a male or non-pregnant female. If female of child-bearing potential, and if sexually active, must be using, or agree to use, a medically-acceptable method of birth control as confirmed by the investigator
- Subject has documented improvement in motor signs ON versus OFF dopaminergic medication, with a change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III score of > 30% OFF to ON medication
Show all 12Show fewer
- Based on the opinion of the Neurosurgeon, the subject is an acceptable candidate for implant of a DBS System that includes: bilateral DBS leads targeted to the STN, extensions, and neurostimulator
- Subject can read and understand English
- Subject is willing and able to attend all study-required visits and complete the study procedures
- Subject is willing and able to be awake during left and right DBS lead implant surgery and for intraoperative LFP recordings
- Intraoperative:
- Required beta band (13 - 30 Hz) signal detected on left and right DBS leads
Who cannot join
- Subject has tremor dominant PD ≥ 2 at rest in head, upper, or lower extremities as measured on the UPDRS Part III Question 20
- Subject requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)
- Subject has a history of prior intracranial surgery (eg, DBS, lesioning, previous surgical ablation)
- Subject is unable to undergo Magnetic Resonance Imaging (MRI) of the head for planning the surgical DBS lead implants
- Based on the opinion of the Neurosurgeon, the subject has a clinically significant structural abnormality(ies) of the brain that would jeopardize subject safety during the DBS lead implant, conduct of the study, or confound the subject's assessments
- Subject has a metallic implant in the head, (eg, aneurysm clip, cochlear implant)
Show all 15Show fewer
- Subject has a major comorbidity increasing the risk of surgery (eg, prior stroke, severe diabetes, severe hypertension, immunocompromised, seizure disorder, active infection, need for chronic anticoagulation other than aspirin)
- Subject has a neurocognitive impairment which exceeds the criteria for PD mild cognitive impairment (PD-MCI) as determined from the center's clinical neuropsychological evaluation prior to DBS for PD
- Subject has, or plans to obtain, an implanted electrical stimulation medical device anywhere in the body (eg, cardiac pacemaker, defibrillator, spinal cord stimulator)
- Subject has, or plans to obtain, an implanted medication pump (eg, DUOPATM infusion pump) and/or portable infusion pump
- Based on the opinion of the investigator, the subject has an abnormal neurological examination that would preclude them from study participation
- Subject is breast feeding
- Subject has Mattis Dementia Rating Scale-2 (DRS-2) score ≤ 130
- Subject has Beck Depression Inventory II (BDI-II) > 25
- Subject is currently participating, or plans to participate, in another investigational study unless written approval is provided by the Medtronic study team
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stanford
Palo Alto, California, 94304
UPMC
Pittsburgh, Pennsylvania, 15261
About this study
Official title: Local Field Potential (LFP) Beta Adaptive Deep Brain Stimulation (aDBS) Feasibility Study
The purpose of this study is to use local field potentials as control signals for adjusting DBS stimulation settings under varying patient states and to assess patient outcomes.
- Conditions
- Parkinson Disease
- Being tested
- The LFP Beta aDBS System
- Keywords
- Parkinson's Disease, 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.
The LFP Beta aDBS SystemDevice
The LFP Beta aDBS System is intended for use in patients receiving DBS for Parkinson's Disease where LFPs may be recorded and analyzed.
| Study group | Role | What they receive |
|---|---|---|
| All Subjects | Experimental | Subjects who meet the intraoperative criteria will receive The LFP Beta aDBS System. Receives: Device: The LFP Beta aDBS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operational Performance: Stimulation amplitude and LFP signals
To characterize the stimulation amplitude and LFP signals during execution of the Medtronic LFP -based aDBS adaptive algorithm. Descriptive statistics will be reported across different PD medication states and subject activities.
Measured: Approximately 6 months post implant
Secondary outcomes (3)
Acute Clinical Effect: motor examination
The UPDRS III motor exam score will be assessed. Descriptive statistics will be reported.
Measured: Approximately 6 months post implant
Acute Clinical Effect: speech
UPDRS III item 18 will be used to score a standardized reading passage. Descriptive statistics will be reported.
Measured: Approximately 6 months post implant
Acute Clinical Effect: dyskinesia
UPDRS IV item 33 will be used to assess dyskinesias. Descriptive statistics will be reported.
Measured: Approximately 6 months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start4 Sep 2018
- Primary completion6 Feb 2019
- Study completion6 Feb 2019
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- aDBS Clinical Research Team, Study director, Medtronic RTG Brain Therapies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446833
- Sponsor's protocol ID
- MDT17076
- Status last verified
- Sep 2019
- First submitted
- 22 Jan 2018
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Field Potential (LFP) Beta Adaptive Deep Brain Stimulation (aDBS) Feasibility Study
- ClinicalTrials.gov ID
- NCT03446833
- Acronym / sponsor ID
- MDT17076
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 1 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 6 Feb 2019 (actual)
- First posted
- 27 Feb 2018 (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.
The purpose of this study is to use local field potentials as control signals for adjusting DBS stimulation settings under varying patient states and to assess patient outcomes.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Subjects | Experimental | Device: The LFP Beta aDBS SystemSubjects who meet the intraoperative criteria will receive The LFP Beta aDBS System. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject has the ability to understand and provide written informed consent for participation in the study prior to the study-related procedures being conducted
- Subject with levodopa-responsive PD of at least 4 years' duration, with symptoms not adequately controlled with medication, including individuals with motor complications of recent onset (from 4 months to 3 years) or with motor complications of longer-standing duration, and who are eligible for bilateral STN DBS surgery
- Subject is ≥ 22 years of age at time of informed consent
- Subject is a male or non-pregnant female. If female of child-bearing potential, and if sexually active, must be using, or agree to use, a medically-acceptable method of birth control as confirmed by the investigator
- Subject has documented improvement in motor signs ON versus OFF dopaminergic medication, with a change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III score of > 30% OFF to ON medication
Key exclusion criteria (15 listed)
- Subject has tremor dominant PD ≥ 2 at rest in head, upper, or lower extremities as measured on the UPDRS Part III Question 20
- Subject requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)
- Subject has a history of prior intracranial surgery (eg, DBS, lesioning, previous surgical ablation)
- Subject is unable to undergo Magnetic Resonance Imaging (MRI) of the head for planning the surgical DBS lead implants
- Based on the opinion of the Neurosurgeon, the subject has a clinically significant structural abnormality(ies) of the brain that would jeopardize subject safety during the DBS lead implant, conduct of the study, or confound the subject's assessments
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 |
|---|---|---|
| The LFP Beta aDBS SystemThe LFP Beta aDBS System is intended for use in patients receiving DBS for Parkinson's Disease where LFPs may be recorded and analyzed. | Device | All Subjects |
Primary outcome
Operational Performance: Stimulation amplitude and LFP signals
Time frame: Approximately 6 months post implant
To characterize the stimulation amplitude and LFP signals during execution of the Medtronic LFP -based aDBS adaptive algorithm. Descriptive statistics will be reported across different PD medication states and subject activities.
3 secondary outcomes
Acute Clinical Effect: motor examination
Time frame: Approximately 6 months post implant
Acute Clinical Effect: speech
Time frame: Approximately 6 months post implant
Acute Clinical Effect: dyskinesia
Time frame: Approximately 6 months post implant
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
Related trials for Parkinson Disease
RecruitingPhase 2
A Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (PD) Participants With Motor Fluctuations
Parkinson Disease
RecruitingEarly Phase 1
[18F]ACI-15916 PET in α-synucleinopathies
Parkinson's Disease (PD), Multiple System Atrophy (MSA)
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
RecruitingPhase 2
A Study to Evaluate the Efficacy, PK, Safety, and Tolerability of VIM0423 in Adults With Parkinson's Disease Tremor Insufficiently Responsive to Dopaminergic Therapy
PARKINSON DISEASE (Disorder)
RecruitingObservational study
Parkinson's Disease in Type 1 Gaucher Disease
Parkinson Disease (PD), Type 1 Gaucher 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.
aDBS Clinical Research Team study director
Medtronic RTG Brain Therapies
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The LFP Beta aDBS System in people with Parkinson Disease, run by MedtronicNeuro at 2 sites 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 12 inclusion and 15 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: stopped early, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 stopped early (reason given: Business decision). Results are not available in the source record.
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?
Operational Performance: Stimulation amplitude and LFP signals (time frame: Approximately 6 months post implant). 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 23 Sep 2019.