Parkinson DiseaseNCT06192823
Feasibility Of Objective Measures and Outpatient Washout in Disease Modifying Trials for Parkinson's Disease
An observational study of Parkinson Disease, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This study will evaluate the feasibility of adding objective measures (FDG-PET imaging, wearable biosensors) to a week-long washout protocol in early-stage Parkinson's disease patients. This study is also determining whether the washout can be conducted in the ambulatory setting. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2022to 18 Feb 2025
- How long will I take part?
- 8 Days
- Phase
- Observational
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Early-stage PD patients as defined by inclusion and exclusion criteria
Who may be able to join
- *A clinical diagnosis of idiopathic PD. The diagnosis will be based upon the presence of at least two of the three cardinal motor signs of this disorder (akinesia/bradykinesia, rest tremor, and rigidity) with at least one of the signs being rest tremor or bradykinesia.
- Clear and dramatic beneficial response to dopaminergic therapy (defined as demonstrating at least 30% improvement in parkinsonian motor signs based upon the UPDRS-III motor examination subscore, following the administration of their dopaminergic medications during the screening neurological examination)
- *Hoehn and Yahr (H\&Y) stage II when off medication.
- Age between 50 and 75 years.
- Subjects must be on dopaminergic therapy for at least one year prior to the screening visit and less than four years prior to the completion of the washout period.
- Subjects must have a stable response to dopaminergic medication.
Show all 9Show fewer
- Available for follow-up for the entire duration of the study.
- Subjects receiving antidepressant medication used specifically for the treatment of depression must be on stable doses for at least eight weeks prior to enrolling in the study.
- Subjects must agree to maintain a stable regimen, if deemed medically appropriate by the treating physician, of any psychotropic medications throughout the study.
Who cannot join
- *Evidence of an alternative diagnosis or secondary parkinsonism, as suggested by:
- Features unusual early in the clinical course (e.g., prominent postural instability, freezing phenomena, or hallucinations unrelated to medications in the first 3 years after symptom onset)
- Dementia preceding motor symptoms
- Neurologic signs of upper motor neuron or cerebellar involvement
- Significant orthostatic hypotension unrelated to medications
- Unequivocal cortical sensory loss (i.e., graphesthesia, stereognosis with intact primary sensory modalities), clear limb ideomotor apraxia, or progressive aphasia
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- Vertical supranuclear gaze palsy, or selective slowing of vertical saccades
- Unequivocal cerebellar abnormalities on examination, such as cerebellar gait, limb ataxia, or cerebellar oculomotor abnormalities (e.g., sustained gaze-evoked nystagmus, macro square wave jerks, hypermetric saccades)
- Documentation of a condition known to produce parkinsonism and plausibly connected to the subject's symptoms (e.g., history of stroke, exposure to toxins, or encephalitis; or neuroleptic use within the past 6 months)
- *The expert evaluating physician, based on the full diagnostic assessment, believes that an alternative syndrome is more likely than PD.
- *Uncontrolled medical condition or clinically significant medical disease that would increase the risk of developing pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension).
- *Evidence of existing dyskinesias.
- *Diagnosis of probable behavioral variant frontotemporal dementia or primary progressive aphasia.
- *Currently active diagnosis of a major psychiatric disorder
- Previous brain operation or injury.
- Active participation in another clinical trial for the treatment of PD.
- *Any current substance use disorder.
- Any history of recurrent or unprovoked seizures.
- Any prior movement disorder treatments that involved intracranial surgery or device implantation.
- Any active implanted intracranial device (e.g., cochlear implant) or implanted device to treat movement disorders (e.g., duodopa pump) whether turned on or off.
- History of suicide attempt.
- A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.
- Inability or unwillingness of subject to give written informed consent.
- *Parkinsonian features restricted to the lower limbs for more than three years.
- *Treatment with a dopamine receptor blocker or a dopamine-depleting agent in a dose and timecourse consistent with drug-induced parkinsonism.
- Rapid progression of gait impairment requiring regular use of a wheelchair.
- *Early bulbar dysfunction, defined as one of severe dysphonia, dysarthria (speech unintelligible most of the time), or dysphagia [requiring soft food, nasogastric (NG) tube, or gastrostomy feeding].
- *Inspiratory respiratory dysfunction defined as either diurnal or nocturnal inspiratory stridor or frequent inspiratory sighs.
- *Recurrent (>1/year) falls because of impaired balance within 3 years of onset.
- *Otherwise unexplained pyramidal tract signs, defined as pyramidal weakness or clear pathologic hyperreflexia (excluding mild reflex asymmetry in the more affected limb and isolated extensor plantar response).
- *Bilateral symmetric parkinsonism throughout the disease course. The patient or caregiver reports bilateral symptom onset with no side predominance, and no side predominance is observed on objective examination.
- Received radiation exposure as part of other recent research studies and individuals who work around radiation will be excluded from the study
- Subjects who do not pass the neuropsychological screening battery.
- *Subjects who, in the opinion of the study neurologist or principal investigator, should not participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
This study will evaluate the feasibility of adding objective measures (FDG-PET imaging, wearable biosensors) to a week-long washout protocol in early-stage Parkinson's disease patients. This study is also determining whether the washout can be conducted in the ambulatory setting.
- Conditions
- Parkinson Disease
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Parkinson's Disease Related Pattern (PDRP) Z-Score From ON Medications to One-week OFF Medications
The Parkinson's Disease-Related Pattern (PDRP) is a disease-specific metabolic brain network derived from fluorodeoxyglucose positron emission tomography (FDG-PET) that reflects Parkinson's disease-related abnormalities in regional cerebral glucose metabolism. Individual PDRP scores represent standardized network expression values (z-scores; A Z-score of 0 represents the population mean) calculated relative to a reference population; there is no fixed minimum or maximum score. Higher values indicate greater expression of the Parkinson's disease metabolic pattern. Change was calculated as Day 8 OFF medication score minus Day 1 ON medication score.
Measured: Day 1 and Day 8
Changes in the Parkinson's Disease Cognitive Pattern (PDCP) Z-Score From ON Medications to One-week OFF Medications
The Parkinson's Disease Cognitive Pattern (PDCP) is a disease-related metabolic brain network derived from fluorodeoxyglucose positron emission tomography (FDG-PET) that reflects metabolic abnormalities associated with cognitive dysfunction in Parkinson's disease. PDCP scores represent standardized network expression values (z-scores; Z-score of 0 represents the population mean) calculated relative to a reference population; there is no fixed minimum or maximum score. Higher values indicate greater expression of the Parkinson's disease cognitive metabolic pattern. Change was calculated as Day 8 OFF medication score minus Day 1 ON medication score.
Measured: Day 1 and Day 8
Daily Kinesia ONE Finger Tapping Speed Scores Over a One-week Medication Washout
Finger tapping speed was measured using the Kinesia ONE wearable motion sensor system during standardized finger tapping tasks. Accelerometer data were used to generate quantitative finger tapping speed scores reflecting bradykinesia severity. Left and right finger tapping scores were calculated separately and averaged to generate a single daily value for each participant. Scores range from 0 to 4, with higher values indicating greater bradykinesia severity (worse motor impairment). Measurements were recorded daily during the one-week dopaminergic medication washout.
Measured: Day 1 through Day 8
Daily Kinesia ONE Rest Tremor Scores Over a One-week Medication Washout
Rest tremor severity was measured using the Kinesia ONE wearable motion sensor system during standardized tremor assessments. Accelerometer data were used to generate quantitative tremor severity scores. Left and right tremor scores were calculated separately and averaged to generate a single daily value for each participant. Scores range from 0 to 4, with higher values indicating greater tremor severity (worse motor impairment). Measurements were recorded daily during the one-week dopaminergic medication washout.
Measured: 1 week
Number of Participants With Adverse Events Related to the Medication Washout
Number of participants experiencing an adverse event judged by the study neurologist to be related to the dopaminergic medication washout during the study period.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start22 Mar 2022
- Primary completion18 Feb 2025
- Study completion18 Feb 2025
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 Vanderbilt University Medical CenterThe 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
- 20 participants (actual)
- Target duration
- 8 Days
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mallory Hacker, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192823
- Sponsor's protocol ID
- 191683
- Status last verified
- Apr 2026
- First submitted
- 22 Nov 2023
- Last updated
- 8 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Of Objective Measures and Outpatient Washout in Disease Modifying Trials for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06192823
- Acronym / sponsor ID
- 191683
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Posted 8 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the feasibility of adding objective measures (FDG-PET imaging, wearable biosensors) to a week-long washout protocol in early-stage Parkinson's disease patients. This study is also determining whether the washout can be conducted in the ambulatory setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Days
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Early-stage PD patients as defined by inclusion and exclusion criteria
Key inclusion criteria (9 listed)
- *A clinical diagnosis of idiopathic PD. The diagnosis will be based upon the presence of at least two of the three cardinal motor signs of this disorder (akinesia/bradykinesia, rest tremor, and rigidity) with at least one of the signs being rest tremor or bradykinesia.
- Clear and dramatic beneficial response to dopaminergic therapy (defined as demonstrating at least 30% improvement in parkinsonian motor signs based upon the UPDRS-III motor examination subscore, following the administration of their dopaminergic medications during the screening neurological examination)
- *Hoehn and Yahr (H\&Y) stage II when off medication.
- Age between 50 and 75 years.
- Subjects must be on dopaminergic therapy for at least one year prior to the screening visit and less than four years prior to the completion of the washout period.
Key exclusion criteria (34 listed)
- *Evidence of an alternative diagnosis or secondary parkinsonism, as suggested by:
- *The expert evaluating physician, based on the full diagnostic assessment, believes that an alternative syndrome is more likely than PD.
- *Uncontrolled medical condition or clinically significant medical disease that would increase the risk of developing pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension).
- *Evidence of existing dyskinesias.
- *Diagnosis of probable behavioral variant frontotemporal dementia or primary progressive aphasia.
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
Changes in the Parkinson's Disease Related Pattern (PDRP) Z-Score From ON Medications to One-week OFF Medications
Time frame: Day 1 and Day 8
The Parkinson's Disease-Related Pattern (PDRP) is a disease-specific metabolic brain network derived from fluorodeoxyglucose positron emission tomography (FDG-PET) that reflects Parkinson's disease-related abnormalities in regional cerebral glucose metabolism. Individual PDRP scores represent standardized network expression values (z-scores; A Z-score of 0 represents the population mean) calculated relative to a reference population; there is no fixed minimum or maximum score. Higher values indicate greater expression of the Parkinson's disease metabolic pattern. Change was calculated as Day 8 OFF medication score minus Day 1 ON medication score.
Changes in the Parkinson's Disease Cognitive Pattern (PDCP) Z-Score From ON Medications to One-week OFF Medications
Time frame: Day 1 and Day 8
The Parkinson's Disease Cognitive Pattern (PDCP) is a disease-related metabolic brain network derived from fluorodeoxyglucose positron emission tomography (FDG-PET) that reflects metabolic abnormalities associated with cognitive dysfunction in Parkinson's disease. PDCP scores represent standardized network expression values (z-scores; Z-score of 0 represents the population mean) calculated relative to a reference population; there is no fixed minimum or maximum score. Higher values indicate greater expression of the Parkinson's disease cognitive metabolic pattern. Change was calculated as Day 8 OFF medication score minus Day 1 ON medication score.
Daily Kinesia ONE Finger Tapping Speed Scores Over a One-week Medication Washout
Time frame: Day 1 through Day 8
Finger tapping speed was measured using the Kinesia ONE wearable motion sensor system during standardized finger tapping tasks. Accelerometer data were used to generate quantitative finger tapping speed scores reflecting bradykinesia severity. Left and right finger tapping scores were calculated separately and averaged to generate a single daily value for each participant. Scores range from 0 to 4, with higher values indicating greater bradykinesia severity (worse motor impairment). Measurements were recorded daily during the one-week dopaminergic medication washout.
Daily Kinesia ONE Rest Tremor Scores Over a One-week Medication Washout
Time frame: 1 week
Rest tremor severity was measured using the Kinesia ONE wearable motion sensor system during standardized tremor assessments. Accelerometer data were used to generate quantitative tremor severity scores. Left and right tremor scores were calculated separately and averaged to generate a single daily value for each participant. Scores range from 0 to 4, with higher values indicating greater tremor severity (worse motor impairment). Measurements were recorded daily during the one-week dopaminergic medication washout.
Number of Participants With Adverse Events Related to the Medication Washout
Time frame: 1 week
Number of participants experiencing an adverse event judged by the study neurologist to be related to the dopaminergic medication washout during the study period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- 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?
An observational study of Parkinson Disease, run by Vanderbilt University Medical Center 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 9 inclusion and 34 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 8 May 2026. 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 8 May 2026). 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?
Changes in the Parkinson's Disease Related Pattern (PDRP) Z-Score From ON Medications to One-week OFF Medications (time frame: Day 1 and Day 8). The study lists 5 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 8 May 2026.