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Parkinson DiseaseNCT03247387

eOnOff - D1 Extension

An observational study of Parkinson Disease, run by Boston University at 1 site in United States.

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

Clinical assessments can only offer a snapshot of daily life with Parkinson's Disease, while wearable devices can offer immensely more information that can improve the understanding of this disease. Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Parkinson Disease
What is being tested?
MC10 BioStampRC, APDM actigraphy device and GENEActiv watch
Type of treatment
Medical device
How many people
34 participants
Where
1 siteUnited States
Study dates
2 May 2017to 22 Jan 2019
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 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Individuals diagnosed with Parkinson's disease.

Who may be able to join

  • Self-reported clinical diagnosis of Parkinson's disease consistent with the United Kingdom (UK) Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria.
  • Self-reported ability to recognize their "wearing off" symptoms and confirmation that they usually improve after their next dose of Parkinson's disease medication.
  • Parkinson's disease Hoehn \& Yahr Stage less than or equal to III (assessed while the patient is "ON").
  • Currently responding to L-Dopa therapy. On a stable dose of L-Dopa (or L-Dopa equivalent) of at least 300 mg total daily dose for at least 28 days prior to Day 1, in conjunction with a dopa decarboxylase inhibitor (e.g., L-Dopa/carbidopa or L-Dopa/benserazide) divided in at least 3 divided doses per day.
  • 45-75 years old
  • Able to understand and cooperate with study procedures and give informed consent.
Show all 12Show fewer
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
  • Body Mass Index (BMI) of 17.5 to 35 kg/m2; and a total body weight of greater than or equal to 45kg.
  • Native English speaker or demonstrated fluency in English.
  • Normal or corrected-to-normal vision
  • A score of greater than or equal to 26 on the Mini Mental State Examination (MMSE).
  • A score of 49 on the Green Form of the WRAT-4 Word Reading Subtest (equivalent to 8th grade reading level)

Who cannot join

  • Treatment with an investigational drug within 30 days of Day 1 of study activities.
  • Diagnosis of moderate to severe alcohol use disorder within 6 months of the screening as disclosed by the subject
  • Employees, student, or advisee of the Principal Investigator
  • History of head injury with clinically significant sequelae (e.g. loss of consciousness for greater than 15 minutes).
  • DSM-V diagnosis of current, or history of, neurological disease (except for Parkinson's disease), Schizophrenia Spectrum or Other Psychotic disorders, or Bipolar and Related Disorders as disclosed by the subject.
  • Subjects with cardiac pacemakers, electronic pumps, or any other implanted medical devices, including deep brain stimulation devices.
  • Women of childbearing age will be required to undergo a pregnancy test to rule out a possible pregnancy.
  • Allergy to adhesives or silicone

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Evans Biomedical Research Center

    Boston, Massachusetts, 02118

Other trials in United States

About this study

Official title: Evaluation of the eON-OFF Mobile Application and Four Actigraphy Devices in Subjects With Parkinson's Disease

Clinical assessments can only offer a snapshot of daily life with Parkinson's Disease, while wearable devices can offer immensely more information that can improve the understanding of this disease. With recent advancements in technology, investigators are now able to use watch-like devices to more effectively measure the symptoms of Parkinson's Disease outside of the doctor's office. The present study is designed to evaluate the usability, applicability, and interpretability of an electronic VA Patient Motor Diary (eON-OFF), MC10 BioStampRC actigraphy sensor, APDM actigraphy sensor and the GENEActiv Watch in persons with Parkinson's Disease. There is no placebo/control group.

Read the detailed description

The proposed study will be comprised of at least four sessions in the Spivack Center (Rm. X-140) on separate days (not counting recruitment, screening, or consent activities), each lasting approximately 1-2 hours. Subjects will commence a 1-week testing period during which they will wear the 3 actigraphy devices in their normal schedule and daily environment. On Days 2, 3, 4, and 5, subjects will use the eON-OFF motor diary application to select their current Parkinson state (e.g. "on", "off"). ON and OFF states are subjective measures identified by subjects, and are commonly used words in Parkinson's Disease treatment and research to describe symptom states. Symptom severity is directly linked to medication effectiveness. "On" is when the medication is working and symptoms are not severe or troublesome. "Off" is when medication has worn off, and symptom severity increases. Subjects will also use the eON-OFF motor diary application to verbally record symptomology every 30 minutes while awake. Subjects will complete paper VA Patient Motor Diaries to record ON and OFF states on Day 2, Day 3, and Day 4. Subjects will then complete the outlined set of activities during Phase I in a second phase to take place approximately one month later. All questionnaires, training and interviews will be administered one-on-one by a trained research assistant. All UPDRS' will be administered by a clinician. Ideally, subjects will be administered the study activities on the days listed above, but they are allowed a flexibility of +/- 4 days for scheduling appointments.

Being tested
MC10 BioStampRC, APDM actigraphy device, GENEActiv watch
Keywords
Wearable device, Patient monitor
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MC10 BioStampRCDevice

    Subjects will fill out electronic diaries on a provisioned iPhone to capture "On" versus "Off" time on a daily basis while at home. In addition, subjects will be asked to wear three actigraphy devices.

  • APDM actigraphy deviceDevice

    Subjects will fill out electronic diaries on a provisioned iPhone to capture "On" versus "Off" time on a daily basis while at home. In addition, subjects will be asked to wear three actigraphy devices.

  • GENEActiv watchDevice

    Subjects will fill out electronic diaries on a provisioned iPhone to capture "On" versus "Off" time on a daily basis while at home. In addition, subjects will be asked to wear three actigraphy devices.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of eON-OFF mobile application ("eON-OFF app") in PD subjects.

    Subjects will use the eON-OFF motor diary application to select their current Parkinson state (e.g. "on", "off"). Subjects will also use the eON-OFF motor diary application to verbally record symptomology every 30 minutes while awake.

    Measured: 2 week long periods spaced a month apart

Secondary outcomes (2)

  1. Equivalence testing of the eON-OFF app on provisioned devices against established paper-based clinical assessment.

    Subjects will complete paper VA Patient Motor Diaries to record ON and OFF states. ON and OFF states are subjective measures identified by subjects, and are commonly used words in Parkinson's Disease treatment and research to describe symptom states.

    Measured: 2 week long periods spaced a month apart

  2. Evaluation of the usability and applicability of 3 wearable sensor systems in assessing clinical measures of PD.

    Subjects will undergo two, 1-week testing periods during which they will wear the 3 actigraphy devices in their normal schedule and daily environment.

    Measured: 2 week long periods spaced a month apart

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2017
  2. Study start2 May 2017
  3. Primary completion1 Jul 2018
  4. Study completion22 Jan 2019

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
Case only
Time perspective
Prospective
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03247387
Sponsor's protocol ID
H-35364
Status last verified
Jan 2019
First submitted
7 Aug 2017
Last updated
24 Jan 2019
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 Boston 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 12 inclusion and 8 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 24 Jan 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?

Assessment of eON-OFF mobile application ("eON-OFF app") in PD subjects. (time frame: 2 week long periods spaced a month apart). 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 NCT03247387.

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 24 Jan 2019.

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eOnOff - D1 Extension (NCT03247387) | AzTrials