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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
*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.
*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
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Early-stage PD patients as defined by inclusion and exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Early-Stage PD | Participants with early-stage Parkinson's disease underwent a one-week supervised dopaminergic medication washout. Assessments included FDG-PET imaging on Day 1 (ON medications) and Day 8 (after washout), as well as daily wearable sensor measurements using the Kinesia ONE system to quantify motor performance (finger tapping bradykinesia and tremor) alongside standard motor and cognitive testing. Safety monitoring and adverse event assessments were performed throughout the washout period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Early-Stage PD | patients with early-stage PD as defined by inclusion/exclusion criteria |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | One participant withdrew and did not have OFF data collected | Posted | Mean | Standard Deviation | Z score | Day 1 and Day 8 |
|
1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Early-Stage PD | Early-Stage PD Cohort | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening parkinsonian symptoms during medication washout | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mallory Hacker | Vanderbilt University Medical Center | 6158757437 | mallory.hacker@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 26, 2024 | Feb 17, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 12, 2024 | Apr 8, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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. | 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. | 1 week |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PD medication (years) | Mean | Standard Deviation | years |
|
| Unified Parkinson's Disease Rating Scale (UPDRS) Part-III overnight OFF medication at screening | The Unified Parkinson's Disease Rating Scale Part III (UPDRS-III) Motor Examination assesses motor symptoms in Parkinson's disease. Scores range from 0-108, with higher scores indicating worse motor impairment. Examinations were rated from standardized videos; rigidity cannot be reliably assessed from video, so the five rigidity items were excluded, resulting in a modified score range of 0-88. The overnight OFF score was collected to measure baseline motor severity without dopaminergic medication and confirm eligibility. | Mean | Standard Deviation | units on a scale |
|
| UPDRS-III ON medication at screening | The Unified Parkinson's Disease Rating Scale Part III (UPDRS-III) Motor Examination assesses motor symptoms in Parkinson's disease. Standard scores range from 0-108, with higher scores indicating worse motor impairment. Examinations were rated from standardized videos; rigidity cannot be reliably assessed from video, so the five rigidity items were excluded, resulting in a modified score range of 0-88. The ON medication score was collected after dopaminergic medication to confirm levodopa responsiveness required for study eligibility. | Mean | Standard Deviation | units on a scale |
|
| Unified Parkinson's Disease Rating Scale, Part III improvement ON medication (%) at screening | Percent improvement in the Unified Parkinson's Disease Rating Scale Part III (UPDRS-III) motor score following dopaminergic medication at screening. Improvement was calculated as [(UPDRS-III OFF - UPDRS-III ON)/UPDRS-III OFF] × 100. Higher values indicate greater motor improvement with medication. This screening measure was used to confirm levodopa responsiveness required for study eligibility. | Mean | Standard Deviation | percentage change |
|
| Levodopa Equivalent Daily Dose (LEDD) | Levodopa Equivalent Daily Dose (LEDD) represents the total daily dopaminergic medication dose converted to levodopa equivalents using established conversion formulas. This measure summarizes overall dopaminergic therapy exposure. | Mean | Standard Deviation | mg/day |
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Early-Stage PD Cohort
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| Primary | 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. | One participant withdrew and did not have OFF data collected | Posted | Mean | Standard Deviation | Z-score | Day 1 and Day 8 |
|
|
|
| Primary | 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. | One participant withdrew and did not have OFF data collected | Posted | Mean | Standard Deviation | units on a scale | Day 1 through Day 8 |
|
|
|
| Primary | 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. | One participant withdrew and did not have OFF data collected | Posted | Mean | Standard Deviation | units on a scale | 1 week |
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|
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| Primary | 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. | 1 participant discontinued the washout on day 5 due to parkinsonian symptoms | Posted | Number | participants | 1 week |
|
|
|
| 20 |
| 0 |
| 20 |
| 1 |
| 20 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Title | Measurements |
|---|---|
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| Finger Tapping Speed Day 4 |
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| Finger Tapping Speed Day 5 |
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| Finger Tapping Speed Day 6 |
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| Finger Tapping Speed Day 7 |
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| Finger Tapping Speed Day 8 |
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| Title | Measurements |
|---|---|
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| Kinesia One Rest Tremor Day 4 |
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| Kinesia One Rest Tremor Day 5 |
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| Kinesia One Rest Tremor Day 6 |
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| Kinesia One Rest Tremor Day 7 |
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| Kinesia One Rest Tremor Day 8 |
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