Parkinson DiseasePD-EEGNCT03103347
Quantification of Beta Activity in Routine EEG Recordings in Parkinson's Disease Patients
An observational study of Parkinson Disease, run by Duke University.
Trial summary
The investigators are studying the relationship between a certain oscillatory brain rhythm (13-30 cycles/sec) that emerges prominently in patients with Parkinson's disease and symptoms of slowness of movement. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 17 Mar 2014to 1 Feb 2017
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a clinical diagnosis of PD will be recruited from Duke outpatient movement disorders clinics. Patients will be adults, age 18 or older who have had PD diagnosis for the following periods of time: Cohort A have had PD diagnosis for <3 years, Cohort B have had PD diagnosis for between 5 and 10 years, and Cohort C have had PD diagnosis for >10 years. All demographic groups were offered participation in the study.
Who may be able to join
- Age 18 or older who have had PD diagnosis for the following periods of time: Cohort A have had PD diagnosis for <3 year, Cohort B have had PD diagnosis for between 5 and 10 years, and Cohort C have had PD diagnosis for >10 years.
Who cannot join
- Patients who have a deep brain stimulator or other surgical treatment to control symptoms of PD
- patients with a history of stroke or prior brain injury
- Patients with familial PD or rapidly progressive disease will also be excluded.
About this study
Official title: Quantification of Beta Activity in Routine EEG Recordings in Parkinson's
The investigators are studying the relationship between a certain oscillatory brain rhythm (13-30 cycles/sec) that emerges prominently in patients with Parkinson's disease and symptoms of slowness of movement. The investigators are recruiting patients with a range of severity of Parkinson's disease symptoms to perform electroencephalography (EEG), in which the study team records brain waves using electrodes placed on the scalp, while patients sit at rest or perform certain hand tasks. The investigators will analyze the recorded brain waves to extract the brain rhythm of interest and relate it to motor symptom severity as well as study its behavior during rest and hand movement.
Read the detailed description
Parkinson's disease (PD) is a devastating, progressive neurodegenerative disease. The hallmark of PD is loss of dopaminergic neurons in the substantia nigra pars compacta (SNc), which disrupts motor circuit processing in the basal ganglia and results in motor dysfunction including tremor, rigidity, and bradykinesia. This disruption of motor circuit processing is reflected in abnormal oscillatory neural activity. For example, recordings of local field potentials with electrodes implanted in the basal ganglia reveal a substantial elevation of beta frequency (15-35 Hz) oscillatory activity in persons with PD, and this increased beta frequency activity is suppressed following levodopa treatment and deep brain stimulation.
However, the link between the frequency and amplitude of abnormal oscillations and the degree of Parkinsonian symptoms is unclear. For example, magneto-encephalography revealed that beta-frequency oscillatory activity is elevated over the motor cortices even in persons with early-stage PD, and there were not any clear differences in beta frequency oscillations between newly diagnosed and under treatment PD. However, this study did not address any changes in the frequency of oscillations or distribution of power across frequencies. For example, a recent study has suggested that variability of ongoing beta-frequency oscillatory activity, in this case recorded from the STN, may be more strongly correlated with symptoms than the amplitude of beta frequency oscillations. Therefore, the objective of the investigator's proposed study is to determine whether there are changes in the characteristics of beta frequency oscillatory activity in the EEG over the motor cortex across differing degrees of Parkinson's disease. Such information is critical to understanding the (possible) link between abnormal oscillatory brain activity and symptom severity, as these signals could be used as potential biomarkers of therapeutic efficacy and to inform the design of new methods of intervention
This is an observational, prospective evaluation of the beta content in routine 20-40 minute EEG recordings from patients with PD for varied periods of time. The investigators anticipate running data collection for 4-6 months in an outpatient movement disorders clinic. Subjects will be identified by their physician and then referred to the study team. Patients that agree to participate will be screened and have all questions answered at the time of their routine appointment. If the patient decides to participate and informed consent is obtained, a clinic appointment will be made for study data collection at a later date. Patient will be instructed not to take their normal dopamine replacement medications for 12 hours prior to the EEG study visit as this can interfere with the brain wave activity being studied. At the study clinic encounter, routine recordings will be made from a total of 33 PD patients; 11 with <3 years of PD diagnosis, 11 with >5 but <10 years of PD diagnosis, and 11 with advanced >10 years of PD diagnosis. EEG will be recorded using an FDA template system to facilitate EEG lead placement by research coordinators. Clinical description of PD severity and duration will be collected from each subject through questionnaire and from review of clinical evaluation. A UPDRS score may be determined for each participant. Following the data collection period, the EEG recordings will be indexed, de-identified, and randomly ordered to blind the subsequent analyses. These indexed EEG segments will be quantitatively analyzed to determine the relative contribution of beta frequency to the recordings, and comparison between the duration and severity of PD symptoms and beta content will also be made.
- Conditions
- Parkinson Disease
- Keywords
- EEG, Parkinson Disease, Beta Oscillations
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Beta Oscillation and Parkinson's Disease Severity
The study team recorded 19 channels of brain surface activity using electroencephalography. The 19 channels were distributed over the scalp. The data streams were analyzed in the frequency domain to determine the extent of beta frequency (13-30Hz) oscillatory content. Prior to the recording, each patient's off-medication motor severity score using Part III of the Unified Parkinson's disease Rating Scale (UPDRS) was assessed.
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start17 Mar 2014
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
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.
- More trials run by Duke 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Warren M Grill, Ph.D, Principal investigator, Professor, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103347
- Sponsor's protocol ID
- Pro00051803
- Acronym
- PD-EEG
- Status last verified
- Mar 2017
- First submitted
- 31 Mar 2017
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Beta Activity in Routine EEG Recordings in Parkinson's
- ClinicalTrials.gov ID
- NCT03103347
- Acronym / sponsor ID
- PD-EEG / Pro00051803
- Conditions
- Parkinson Disease
- Keywords
- EEG, Parkinson Disease, Beta Oscillations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 17 Mar 2014 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 6 Apr 2017 (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 investigators are studying the relationship between a certain oscillatory brain rhythm (13-30 cycles/sec) that emerges prominently in patients with Parkinson's disease and symptoms of slowness of movement. The investigators are recruiting patients with a range of severity of Parkinson's disease symptoms to perform electroencephalography (EEG), in which the study team records brain waves using electrodes placed on the scalp, while patients sit at rest or perform certain hand tasks. The investigators will analyze the recorded brain waves to extract the brain rhythm of interest and relate it to motor symptom severity as well as study its behavior during rest and hand movement.
Detailed description
Parkinson's disease (PD) is a devastating, progressive neurodegenerative disease. The hallmark of PD is loss of dopaminergic neurons in the substantia nigra pars compacta (SNc), which disrupts motor circuit processing in the basal ganglia and results in motor dysfunction including tremor, rigidity, and bradykinesia. This disruption of motor circuit processing is reflected in abnormal oscillatory neural activity. For example, recordings of local field potentials with electrodes implanted in the basal ganglia reveal a substantial elevation of beta frequency (15-35 Hz) oscillatory activity in persons with PD, and this increased beta frequency activity is suppressed following levodopa treatment and deep brain stimulation.
However, the link between the frequency and amplitude of abnormal oscillations and the degree of Parkinsonian symptoms is unclear. For example, magneto-encephalography revealed that beta-frequency oscillatory activity is elevated over the motor cortices even in persons with early-stage PD, and there were not any clear differences in beta frequency oscillations between newly diagnosed and under treatment PD. However, this study did not address any changes in the frequency of oscillations or distribution of power across frequencies. For example, a recent study has suggested that variability of ongoing beta-frequency oscillatory activity, in this case recorded from the STN, may be more strongly correlated with symptoms than the amplitude of beta frequency oscillations. Therefore, the objective of the investigator's proposed study is to determine whether there are changes in the characteristics of beta frequency oscillatory activity in the EEG over the motor cortex across differing degrees of Parkinson's disease. Such information is critical to understanding the (possible) link between abnormal oscillatory brain activity and symptom severity, as these signals could be used as potential biomarkers of therapeutic efficacy and to inform the design of new methods of intervention
This is an observational, prospective evaluation of the beta content in routine 20-40 minute EEG recordings from patients with PD for varied periods of time. The investigators anticipate running data collection for 4-6 months in an outpatient movement disorders clinic. Subjects will be identified by their physician and then referred to the study team. Patients that agree to participate will be screened and have all questions answered at the time of their routine appointment. If the patient decides to participate and informed consent is obtained, a clinic appointment will be made for study data collection at a later date. Patient will be instructed not to take their normal dopamine replacement medications for 12 hours prior to the EEG study visit as this can interfere with the brain wave activity being studied. At the study clinic encounter, routine recordings will be made from a total of 33 PD patients; 11 with <3 years of PD diagnosis, 11 with >5 but <10 years of PD diagnosis, and 11 with advanced >10 years of PD diagnosis. EEG will be recorded using an FDA template system to facilitate EEG lead placement by research coordinators. Clinical description of PD severity and duration will be collected from each subject through questionnaire and from review of clinical evaluation. A UPDRS score may be determined for each participant. Following the data collection period, the EEG recordings will be indexed, de-identified, and randomly ordered to blind the subsequent analyses. These indexed EEG segments will be quantitatively analyzed to determine the relative contribution of beta frequency to the recordings, and comparison between the duration and severity of PD symptoms and beta content will also be made.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a clinical diagnosis of PD will be recruited from Duke outpatient movement disorders clinics. Patients will be adults, age 18 or older who have had PD diagnosis for the following periods of time: Cohort A have had PD diagnosis for <3 years, Cohort B have had PD diagnosis for between 5 and 10 years, and Cohort C have had PD diagnosis for >10 years. All demographic groups were offered participation in the study.
Key inclusion criteria (1 listed)
- Age 18 or older who have had PD diagnosis for the following periods of time: Cohort A have had PD diagnosis for <3 year, Cohort B have had PD diagnosis for between 5 and 10 years, and Cohort C have had PD diagnosis for >10 years.
Key exclusion criteria (3 listed)
- Patients who have a deep brain stimulator or other surgical treatment to control symptoms of PD
- patients with a history of stroke or prior brain injury
- Patients with familial PD or rapidly progressive disease will also be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between Beta Oscillation and Parkinson's Disease Severity
Time frame: 40 minutes
The study team recorded 19 channels of brain surface activity using electroencephalography. The 19 channels were distributed over the scalp. The data streams were analyzed in the frequency domain to determine the extent of beta frequency (13-30Hz) oscillatory content. Prior to the recording, each patient's off-medication motor severity score using Part III of the Unified Parkinson's disease Rating Scale (UPDRS) was assessed.
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 27 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Warren M Grill, Ph.D principal investigator
Professor, Duke University
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Duke University.
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 3 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 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Correlation between Beta Oscillation and Parkinson's Disease Severity (time frame: 40 minutes). 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 27 Apr 2023.