Parkinson's DiseaseDBSNCT02304848
Effects of Deep Brain Stimulation (DBS) Frequency on Neural Synchrony
A study testing DBS (Deep Brain Stimulation) in people with Parkinson's Disease, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of low frequency deep brain stimulation on subthalamic nucleus neural synchrony. Low frequency stimulation does not improve the cardinal motor signs of Parkinson's disease, and may be beneficial only for gait and speech. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- DBS (Deep Brain Stimulation)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 28 Nov 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of idiopathic Parkinson's disease, with bilateral symptoms at Hoehn and Yahr Stage greater than or equal to II.
- Documented improvement in motor signs on versus off dopaminergic medication, with a change in the Unified Parkinson's Disease Rating Scale motor (UPDRS III) score of >= 30% off to on medication.
- The presence of complications of medication such as wearing off signs, fluctuating responses and/or dyskinesias, and/or medication refractory tremor, and/or impairment in the quality of life on or off medication due to these factors.
- Subjects should be on stable doses of medications, which should remain unchanged until the DBS system is activated. After the DBS system is optimized (during which time the overall medication dose may be reduced to avoid discomfort and complications such as dyskinesias) the medication dose should remain unchanged, if possible, for the duration of the study.
- Treatment with carbidopa/levodopa, and with a dopamine agonist at the maximal tolerated doses as determined by a movement disorders neurologist.
- Age > 18
Who cannot join
- Subjects with significant cognitive impairment and/or dementia as determined by a standardized neuropsychological battery.
- Subjects with clinically active depression, defined according to the Diagnostic and Statistical manual of Mental Disorders, Fourth Edition (DSM-IV) criteria and as scored on a validated depression assessment scale.
- Subjects with very advanced Parkinson's disease, Hoehn and Yahr stage 5 on medication (non-ambulatory).
- Age > 80.
- Subjects with an implanted electronic device such as a neurostimulator, cardiac pacemaker/defibrillator or medication pump.
- Subjects, who are pregnant, are capable of becoming pregnant, or who are breast feeding.
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- Patients with cortical atrophy out of proportion to age or focal brain lesions that could indicate a non-idiopathic movement disorder as determined by MRI
- Subjects having a major comorbidity increasing the risk of surgery (prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin).
- Subjects having any prior intracranial surgery.
- Subjects with a history of seizures.
- Subjects, who are immunocompromised.
- Subjects with an active infection.
- Subjects, who require diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) to treat a chronic condition.
- Subjects, who have an inability to comply with study follow-up visits.
- Subjects, who are unable to understand or sign the informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center
Stanford, California, 94305
About this study
The purpose of this study is to evaluate the effects of low frequency deep brain stimulation on subthalamic nucleus neural synchrony. Low frequency stimulation does not improve the cardinal motor signs of Parkinson's disease, and may be beneficial only for gait and speech. This study will provide insight into what the effects of low frequency stimulation are on neural synchrony.
- Conditions
- Parkinson's Disease
- Being tested
- DBS (Deep Brain Stimulation)
- Keywords
- Parkinson's Disease, DBS, Deep Brain Stimulation, Subthalamic Nucleus
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBS (Deep Brain Stimulation)Other
Applying low frequency and high frequency deep brain stimulation to subthalamic nucleus.
| Study group | Role | What they receive |
|---|---|---|
| DBS (Deep Brain Stimulation) | Experimental | DBS ( Deep Brain Stimulation) ( both high and low frequency deep brain stimulation will be applied to the subthalamic nucleus) Receives: Other: DBS (Deep Brain Stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low frequency stimulation versus no stimulation
The changes in neuronal oscillations, measured in power (dB/Hz) and frequency (Hz), that are significantly different between periods of low frequency stimulation and periods of no stimulation - during rest - in people with Parkinson's disease off medications.
Measured: 3 years
Secondary outcomes (1)
Low frequency stimulation versus high frequency stimulation
To determine if the effects of low frequency stimulation are due to using a lower total power delivered than normal therapeutic high frequency stimulation.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startOct 2012
- Primary completion28 Nov 2017
- Study completion28 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen M. Bronte-Stewart, Stanford University
- Investigators
- Helen Bronte-Stewart, MD, MSE, FAAN, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304848
- Sponsor's protocol ID
- 60130
- Acronym
- DBS
- Status last verified
- Mar 2019
- First submitted
- 6 Aug 2014
- Last updated
- 11 Mar 2019
- Results posted
- No
Publications
O'Day J, Syrkin-Nikolau J, Anidi C, Kidzinski L, Delp S, Bronte-Stewart H. The turning and barrier course reveals gait parameters for detecting freezing of gait and measuring the efficacy of deep brain stimulation. PLoS One. 2020 Apr 29;15(4):e0231984. doi: 10.1371/journal.pone.0231984. eCollection 2020.
PubMed 32348346
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Deep Brain Stimulation (DBS) Frequency on Neural Synchrony
- ClinicalTrials.gov ID
- NCT02304848
- Acronym / sponsor ID
- DBS / 60130
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, DBS, Deep Brain Stimulation, Subthalamic Nucleus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- 28 Nov 2017 (actual)
- Study completion
- 28 Nov 2017 (actual)
- First posted
- 2 Dec 2014 (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 study is to evaluate the effects of low frequency deep brain stimulation on subthalamic nucleus neural synchrony. Low frequency stimulation does not improve the cardinal motor signs of Parkinson's disease, and may be beneficial only for gait and speech. This study will provide insight into what the effects of low frequency stimulation are on neural synchrony.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBS (Deep Brain Stimulation) | Experimental | Other: DBS (Deep Brain Stimulation)DBS ( Deep Brain Stimulation) ( both high and low frequency deep brain stimulation will be applied to the subthalamic nucleus) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A diagnosis of idiopathic Parkinson's disease, with bilateral symptoms at Hoehn and Yahr Stage greater than or equal to II.
- Documented improvement in motor signs on versus off dopaminergic medication, with a change in the Unified Parkinson's Disease Rating Scale motor (UPDRS III) score of >= 30% off to on medication.
- The presence of complications of medication such as wearing off signs, fluctuating responses and/or dyskinesias, and/or medication refractory tremor, and/or impairment in the quality of life on or off medication due to these factors.
- Subjects should be on stable doses of medications, which should remain unchanged until the DBS system is activated. After the DBS system is optimized (during which time the overall medication dose may be reduced to avoid discomfort and complications such as dyskinesias) the medication dose should remain unchanged, if possible, for the duration of the study.
- Treatment with carbidopa/levodopa, and with a dopamine agonist at the maximal tolerated doses as determined by a movement disorders neurologist.
Key exclusion criteria (15 listed)
- Subjects with significant cognitive impairment and/or dementia as determined by a standardized neuropsychological battery.
- Subjects with clinically active depression, defined according to the Diagnostic and Statistical manual of Mental Disorders, Fourth Edition (DSM-IV) criteria and as scored on a validated depression assessment scale.
- Subjects with very advanced Parkinson's disease, Hoehn and Yahr stage 5 on medication (non-ambulatory).
- Age > 80.
- Subjects with an implanted electronic device such as a neurostimulator, cardiac pacemaker/defibrillator or medication pump.
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 |
|---|---|---|
| DBS (Deep Brain Stimulation)Applying low frequency and high frequency deep brain stimulation to subthalamic nucleus. | Other | DBS (Deep Brain Stimulation) |
Primary outcome
Low frequency stimulation versus no stimulation
Time frame: 3 years
The changes in neuronal oscillations, measured in power (dB/Hz) and frequency (Hz), that are significantly different between periods of low frequency stimulation and periods of no stimulation - during rest - in people with Parkinson's disease off medications.
1 secondary outcome
Low frequency stimulation versus high frequency stimulation
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Derived from this study: PubMed 32348346O'Day J, Syrkin-Nikolau J, Anidi C, Kidzinski L, Delp S, Bronte-Stewart H. The turning and barrier course reveals gait parameters for detecting freezing of gait and measuring the efficacy of deep brain stimulation. PLoS One. 2020 Apr 29;15(4):e0231984. doi: 10.1371/journal.pone.0231984. eCollection 2020.
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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.
Helen Bronte-Stewart, MD, MSE, FAAN principal investigator
Stanford 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 DBS (Deep Brain Stimulation) in people with Parkinson's Disease, run by Stanford 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 6 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: finished, as of the sponsor's last update on 11 Mar 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Low frequency stimulation versus no stimulation (time frame: 3 years). 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 NCT02304848, 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 11 Mar 2019.