Parkinson DiseaseNCT03204526
Low Frequency Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease
A study testing deep brain stimulation in people with Parkinson Disease and Cognitive Impairment, run by University of California, Davis at 1 site in United States.
Trial summary
Prospective trial of low frequency deep brain stimulation of the ventral subthalamic nucleus to improve cognitive performance in patients with advanced Parkinson's disease. All study participants have undergone DBS implantation surgery as part of their routine care for motor manifestations of Parkinson's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Cognitive Impairment
- What is being tested?
- deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Nov 2019
- Phase
- Interventional
- 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
Who may be able to join
- Parkinson's disease, undergoing deep brain stimulation implantation as part of their routine management of motor symptoms.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Sacramento, California, 95817
About this study
Official title: Safety and Feasibility of Using Low Frequency Deep Brain Stimulation of the Subthalamic Nucleus to Improve Cognitive Performance in Patients With Parkinson's Disease
Prospective trial of low frequency deep brain stimulation of the ventral subthalamic nucleus to improve cognitive performance in patients with advanced Parkinson's disease. All study participants have undergone DBS implantation surgery as part of their routine care for motor manifestations of Parkinson's disease. In this study, a temporary low frequency period of stimulation will be applied to determine its effects on cognition.
Read the detailed description
In this randomized cross-over pilot study, our primary aim was to determine the effect of theta (5 Hz), and gamma (130 Hz) frequency stimulation in the ventral STN on cognitive control in patients with PD. This study provides a first look at frequency dependent modulation of cognitive function and provides important insights into the utility of DBS for non-motor symptoms of PD and other neuropsychiatric disorders.
- Conditions
- Parkinson Disease, Cognitive Impairment
- Being tested
- deep brain stimulation
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep brain stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| low frequency stimulation (LFS) | Experimental | Low-frequency deep brain stimulation of the subthalamic nucleus Receives: Device: deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Reaction Time for Computerized Color Naming Stroop Task
The Stroop Color and Word Test (SCWT) is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect.
Measured: 2 days
Mean Accuracy Rates Using Computerized Color Naming Stroop Task
The Stroop Color and Word Test (SCWT) is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect.
Measured: 2 days
Secondary outcomes (2)
Number of Participants With Worsening Depression Using Beck's Depression Index
Questionnaire with numerical score indicating level of depression. Individual scale items are scored on a 4-point continuum (0=least, 3=most), with a total summed score range of 0-63. Higher scores indicate greater depressive severity.
Measured: 2 days
Number of Participants Showing Motor Worsening Using the Unified Parkinson's Disease Rating Scale (UPDRS-III)
The UPDRS scale is a rating tool used to gauge the course of Parkinson's disease in patients and consists of the following five segments: 1) Mentation, Behavior, and Mood, 2) ADL, 3) Motor sections, 4) Modified Hoehn and Yahr Scale, and 5) Schwab and England ADL scale.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study startJun 2015
- Primary completionNov 2019
- Study completionNov 2019
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 Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204526
- Sponsor's protocol ID
- 693382
- Status last verified
- Jun 2021
- First submitted
- 9 Dec 2016
- Last updated
- 23 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Using Low Frequency Deep Brain Stimulation of the Subthalamic Nucleus to Improve Cognitive Performance in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03204526
- Acronym / sponsor ID
- 693382
- Conditions
- Parkinson Disease, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Posted 23 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective trial of low frequency deep brain stimulation of the ventral subthalamic nucleus to improve cognitive performance in patients with advanced Parkinson's disease. All study participants have undergone DBS implantation surgery as part of their routine care for motor manifestations of Parkinson's disease. In this study, a temporary low frequency period of stimulation will be applied to determine its effects on cognition.
Detailed description
In this randomized cross-over pilot study, our primary aim was to determine the effect of theta (5 Hz), and gamma (130 Hz) frequency stimulation in the ventral STN on cognitive control in patients with PD. This study provides a first look at frequency dependent modulation of cognitive function and provides important insights into the utility of DBS for non-motor symptoms of PD and other neuropsychiatric disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| low frequency stimulation (LFS) | Experimental | Device: deep brain stimulationLow-frequency deep brain stimulation of the subthalamic nucleus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parkinson's disease, undergoing deep brain stimulation implantation as part of their routine management of motor symptoms.
Key exclusion criteria (0 listed)
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 stimulation | Device | low frequency stimulation (LFS) |
Primary outcome
Mean Reaction Time for Computerized Color Naming Stroop Task
Time frame: 2 days
The Stroop Color and Word Test (SCWT) is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect.
Mean Accuracy Rates Using Computerized Color Naming Stroop Task
Time frame: 2 days
The Stroop Color and Word Test (SCWT) is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect.
2 secondary outcomes
Number of Participants With Worsening Depression Using Beck's Depression Index
Time frame: 2 days
Number of Participants Showing Motor Worsening Using the Unified Parkinson's Disease Rating Scale (UPDRS-III)
Time frame: 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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?
A study testing deep brain stimulation in people with Parkinson Disease and Cognitive Impairment, run by University of California, Davis 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 1 inclusion and 0 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 23 Jun 2021. 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 23 Jun 2021). 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?
Mean Reaction Time for Computerized Color Naming Stroop Task (time frame: 2 days). The study lists 2 primary outcomes in all. 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 Jun 2021.