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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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.

  1. 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.

  1. First posted6 Apr 2017
  2. Study start17 Mar 2014
  3. Primary completion1 Feb 2017
  4. Study completion1 Feb 2017

Resources

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)
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

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.

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