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Lack of activity and not meeting recruitment goals within expected timeframe
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| Name | Class |
|---|---|
| Michael J. Fox Foundation for Parkinson's Research | OTHER |
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This study is a single-site, double-blinded, randomized clinical trial designed to elucidate mechanism(s) of action for symptomatic benefits observed in Parkinson's disease (PD)
Patients treating twice daily using a non-invasive brainstem modulation device. Study participants will self-administer treatments in the home setting over a period of 12 weeks. Changes in cerebral blood flow perfusion, cerebrovascular reactivity and functional connectivity between the pre-treatment baseline and the end of the treatment period will be monitored and compared to changes in validated standardized clinical measures of motor and non-motor symptoms in PD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 | Experimental | Participants will receive Experimental treatment 1 stimulation for a duration of 12 weeks, twice daily for 19 minutes |
|
| Treatment 2 | Experimental | Participants will receive Experimental treatment 2 stimulation for a duration of 12 weeks, twice daily for 19 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive brainstem stimulation | Device | Study participants will self-administer ~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral Blood Flow (CBF) Perfusion | Cerebral blood flow (CBF) measured using pseudo Continuous Arterial Spin Labeling (pCASL) magnetic resonance imaging (MRI) will be used to monitor changes in global perfusion | baseline |
| Cerebral Blood Flow (CBF) Perfusion | Cerebral blood flow (CBF) measured using pseudo Continuous Arterial Spin Labeling (pCASL) magnetic resonance imaging (MRI) will be used to monitor changes in global perfusion | end of treatment (week 12) |
| Cerebrovascular Reactivity | Cerebral blood flow is measured with pCASL MRI at baseline and during hypercapnic challenge. The percent change in CBF is divided by the increase in end-tidal CO2 measured in mmHg, measured with RespirACT system | baseline |
| Cerebrovascular Reactivity | Cerebral blood flow is measured with pCASL MRI at baseline and during hypercapnic challenge. The percent change in CBF is divided by the increase in end-tidal CO2 measured in mmHg, measured with RespirACT system | end of treatment (week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Functional Connectivity | Changes to the within-network connectivity of the DMN (Default Mode Network) | baseline and end of treatment (week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cerebral Haemodynamics | Transcranial Doppler sonography (TCD), a non-invasive ultrasound, will be used to monitor changes in cerebral blood flow velocity (cm/s) in response to a hypercapnic challenge. | baseline and end of treatment (week 12) |
| Durability of Change of Cerebral Blood Flow (CBF) Perfusion |
Inclusion Criteria:
Exclusion Criteria:
Women of child-bearing potential (i.e., are not yet 3 years removed from their first menopausal symptom), who are not abstinent or exclusively in same sex relationships must:
Test negative for pregnancy as indicated by a negative urine pregnancy test
Agree to use an approved contraception method
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| Name | Affiliation | Role |
|---|---|---|
| Christopher T Whitlow, MD, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
Individual participant data (IPD) will not be available to other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment 1 | Participants will receive Experimental treatment 1 stimulation for a duration of 12 weeks, twice daily for 19 minutes Non-invasive brainstem stimulation: Study participants will self-administer ~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration. |
| FG001 | Treatment 2 | Participants will receive Experimental treatment 2 stimulation for a duration of 12 weeks, twice daily for 19 minutes Non-invasive brainstem stimulation: Study participants will self-administer ~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment 1 | Participants will receive Experimental treatment 1 stimulation for a duration of 12 weeks, twice daily for 19 minutes Non-invasive brainstem stimulation: Study participants will self-administer ~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Cerebral Blood Flow (CBF) Perfusion | Cerebral blood flow (CBF) measured using pseudo Continuous Arterial Spin Labeling (pCASL) magnetic resonance imaging (MRI) will be used to monitor changes in global perfusion | Posted | Mean | Standard Deviation | ml/100g/min | baseline |
|
17 weeks
Treatment site discomfort, Headache, Ear pain, Tinnitus
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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 | Treatment 1 | Participants will receive Experimental treatment 1 stimulation for a duration of 12 weeks, twice daily for 19 minutes Non-invasive brainstem stimulation: Study participants will self-administer ~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Treatment site discomfort | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Manager | Atrium Health Wake Forest Baptist | 336-713-8793 | richarlette.hightower@advocatehealth.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 | Jul 24, 2023 | Jun 24, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 27, 2024 | Jun 24, 2025 | ICF_001.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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|
Arterial arrival time (AAT) measured using pseudo Continuous Arterial Spin Labeling (pCASL) magnetic resonance imaging (MRI) will be used to monitor changes in global perfusion. |
| baseline and the post-treatment follow-up (week 17) |
| Durability of Change of Cerebrovascular Reactivity | AAT measured using pCASL MRI after a hypercapnic challenge will be used to monitor changes in cerebrovascular reactivity | baseline and the post-treatment follow-up (week 17) |
| Durability of Change of Functional Connectivity | Resting-state magnetic resonance imaging (rs-MRI) will be used to monitor changes in functional connectivity | baseline and the post-treatment follow-up (week 17) |
| Change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | Used to follow the longitudinal course of symptoms of Parkinson's disease - Each parkinsonian sign or symptom is rated on a 5-point Likert-type scale (ranging from 0 to 4), with higher scores indicating more severe impairment. The maximum total UPDRS score is 199, indicating the worst possible disability from PD | baseline, end of treatment (week 12), and the post-treatment follow-up (week 17) |
| Change in the Timed Up and Go Test | To determine fall risk and measure the progress of balance, sit to stand and walking (ranging from ≤10 seconds as normal to 30 seconds as high fall risk). | baseline, end of treatment (week 12) and the post-treatment follow-up (week 17) |
| Change in the Montreal Cognitive Assessment | Cognitive screening test - range from zero to 30, with a score of 26 and higher generally considered normal. | baseline, end of treatment (week 12) and the post-treatment follow-up (week 17) |
| Change in the Non-Motor Symptom Scale | Scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease - 30-item rater-based scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The Non-Motor Symptom Scale measures the severity and frequency of non-motor symptoms across nine dimensions - the total score significantly increased with disease severity and duration meaning that the number of individual non-motor symptoms reported by our patients increases as the disease progresses. Score range 0 - 360. | Change between the baseline and end of treatment (week 12) measure. |
| Change in the Non-Motor Symptom Scale | Scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease - 30-item rater-based scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The Non-Motor Symptom Scale measures the severity and frequency of non-motor symptoms across nine dimensions - the total score significantly increased with disease severity and duration meaning that the number of individual non-motor symptoms reported by our patients increases as the disease progresses. Score range 0 - 360. | Change between the baseline and the post-treatment follow-up (week 17) measure. |
| Change in the Geriatric Depression Scale | A self-report measure of depression in older adults - Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression. | baseline, end of treatment (week 12) and the post-treatment follow-up (week 17) |
| Change in the Parkinson's Anxiety Scale | Anxiety assessment - The PAS is a 12-item observer or patient-rated scale with three subscales, for persistent, episodic anxiety and avoidance behavior - There is a maximum total score of 48. Higher scores indicate great experiences of anxiety. | baseline, end of treatment (week 12) and the post-treatment follow-up (week 17) |
| Change in the Epworth Sleepiness Scale | A self-administered questionnaire to assess the daytime sleepiness - The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'. | baseline, end of treatment (week 12) and the post-treatment follow-up (week 17) |
| Change in the Functional Assessment of Chronic Illness Therapy - Fatigue | A tool to help manage chronic illness - The responses to the 13 items on the FACIT fatigue questionnaire are each measured on a 4-point Likert scale. Thus, the total score ranges from 0 to 52. High scores represent less fatigue | baseline, end of treatment (week 12) and the post-treatment follow-up (week 17) |
| Change in Arterial Stiffness | Arterial stiffness will be assessed as carotid-femoral pulse wave velocity (PWV). PWV is calculated by dividing the distance between the carotid and femoral arteries by the pulse transit time. | baseline and end of treatment (week 12) |
| Withdrawal by Subject |
|
| BG001 | Treatment 2 | Participants will receive Experimental treatment 2 stimulation for a duration of 12 weeks, twice daily for 19 minutes Non-invasive brainstem stimulation: Study participants will self-administer ~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants will receive Experimental treatment 2 stimulation for a duration of 12 weeks, twice daily for 19 minutes Non-invasive brainstem stimulation: Study participants will self-administer ~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration. |
|
|
| Primary | Cerebral Blood Flow (CBF) Perfusion | Cerebral blood flow (CBF) measured using pseudo Continuous Arterial Spin Labeling (pCASL) magnetic resonance imaging (MRI) will be used to monitor changes in global perfusion | Posted | Mean | Standard Deviation | ml/100g/min | end of treatment (week 12) |
|
|
|
| Primary | Cerebrovascular Reactivity | Cerebral blood flow is measured with pCASL MRI at baseline and during hypercapnic challenge. The percent change in CBF is divided by the increase in end-tidal CO2 measured in mmHg, measured with RespirACT system | Only 3 total participants had usable data | Posted | Mean | Standard Deviation | % change CBF/change in CO2 (mmHg) | baseline |
|
|
|
| Primary | Cerebrovascular Reactivity | Cerebral blood flow is measured with pCASL MRI at baseline and during hypercapnic challenge. The percent change in CBF is divided by the increase in end-tidal CO2 measured in mmHg, measured with RespirACT system | Only 3 total participants had usable data | Posted | Mean | Standard Deviation | % change CBF/change in CO2 (mmHg) | end of treatment (week 12) |
|
|
|
| Secondary | Percent Change in Functional Connectivity | Changes to the within-network connectivity of the DMN (Default Mode Network) | Posted | Mean | Standard Deviation | Percent Change in Default Mode Network | baseline and end of treatment (week 12) |
|
|
|
| Other Pre-specified | Change in Cerebral Haemodynamics | Transcranial Doppler sonography (TCD), a non-invasive ultrasound, will be used to monitor changes in cerebral blood flow velocity (cm/s) in response to a hypercapnic challenge. | Not Posted | baseline and end of treatment (week 12) | Participants |
| Other Pre-specified | Durability of Change of Cerebral Blood Flow (CBF) Perfusion | Arterial arrival time (AAT) measured using pseudo Continuous Arterial Spin Labeling (pCASL) magnetic resonance imaging (MRI) will be used to monitor changes in global perfusion. | Not Posted | baseline and the post-treatment follow-up (week 17) | Participants |
| Other Pre-specified | Durability of Change of Cerebrovascular Reactivity | AAT measured using pCASL MRI after a hypercapnic challenge will be used to monitor changes in cerebrovascular reactivity | Not Posted | baseline and the post-treatment follow-up (week 17) | Participants |
| Other Pre-specified | Durability of Change of Functional Connectivity | Resting-state magnetic resonance imaging (rs-MRI) will be used to monitor changes in functional connectivity | Not Posted | baseline and the post-treatment follow-up (week 17) | Participants |
| Other Pre-specified | Change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | Used to follow the longitudinal course of symptoms of Parkinson's disease - Each parkinsonian sign or symptom is rated on a 5-point Likert-type scale (ranging from 0 to 4), with higher scores indicating more severe impairment. The maximum total UPDRS score is 199, indicating the worst possible disability from PD | Not Posted | baseline, end of treatment (week 12), and the post-treatment follow-up (week 17) | Participants |
| Other Pre-specified | Change in the Timed Up and Go Test | To determine fall risk and measure the progress of balance, sit to stand and walking (ranging from ≤10 seconds as normal to 30 seconds as high fall risk). | Not Posted | baseline, end of treatment (week 12) and the post-treatment follow-up (week 17) | Participants |
| Other Pre-specified | Change in the Montreal Cognitive Assessment | Cognitive screening test - range from zero to 30, with a score of 26 and higher generally considered normal. | Not Posted | baseline, end of treatment (week 12) and the post-treatment follow-up (week 17) | Participants |
| Other Pre-specified | Change in the Non-Motor Symptom Scale | Scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease - 30-item rater-based scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The Non-Motor Symptom Scale measures the severity and frequency of non-motor symptoms across nine dimensions - the total score significantly increased with disease severity and duration meaning that the number of individual non-motor symptoms reported by our patients increases as the disease progresses. Score range 0 - 360. | Not Posted | Change between the baseline and end of treatment (week 12) measure. | Participants |
| Other Pre-specified | Change in the Non-Motor Symptom Scale | Scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease - 30-item rater-based scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The Non-Motor Symptom Scale measures the severity and frequency of non-motor symptoms across nine dimensions - the total score significantly increased with disease severity and duration meaning that the number of individual non-motor symptoms reported by our patients increases as the disease progresses. Score range 0 - 360. | Not Posted | Change between the baseline and the post-treatment follow-up (week 17) measure. | Participants |
| Other Pre-specified | Change in the Geriatric Depression Scale | A self-report measure of depression in older adults - Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression. | Not Posted | baseline, end of treatment (week 12) and the post-treatment follow-up (week 17) | Participants |
| Other Pre-specified | Change in the Parkinson's Anxiety Scale | Anxiety assessment - The PAS is a 12-item observer or patient-rated scale with three subscales, for persistent, episodic anxiety and avoidance behavior - There is a maximum total score of 48. Higher scores indicate great experiences of anxiety. | Not Posted | baseline, end of treatment (week 12) and the post-treatment follow-up (week 17) | Participants |
| Other Pre-specified | Change in the Epworth Sleepiness Scale | A self-administered questionnaire to assess the daytime sleepiness - The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'. | Not Posted | baseline, end of treatment (week 12) and the post-treatment follow-up (week 17) | Participants |
| Other Pre-specified | Change in the Functional Assessment of Chronic Illness Therapy - Fatigue | A tool to help manage chronic illness - The responses to the 13 items on the FACIT fatigue questionnaire are each measured on a 4-point Likert scale. Thus, the total score ranges from 0 to 52. High scores represent less fatigue | Not Posted | baseline, end of treatment (week 12) and the post-treatment follow-up (week 17) | Participants |
| Other Pre-specified | Change in Arterial Stiffness | Arterial stiffness will be assessed as carotid-femoral pulse wave velocity (PWV). PWV is calculated by dividing the distance between the carotid and femoral arteries by the pulse transit time. | Not Posted | baseline and end of treatment (week 12) | Participants |
| 0 |
| 5 |
| 0 |
| 5 |
| 5 |
| 5 |
| EG001 | Treatment 2 | Participants will receive Experimental treatment 2 stimulation for a duration of 12 weeks, twice daily for 19 minutes Non-invasive brainstem stimulation: Study participants will self-administer ~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration. | 0 | 4 | 0 | 4 | 2 | 4 |
| Tinnitus | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Ear pain | General disorders | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |