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| ID | Type | Description | Link |
|---|---|---|---|
| I01 RX003397 1-01A1 | Other Grant/Funding Number | US Department of Veterans Affairs | |
| I01RX003397 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
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This study investigates whether vestibular (inner ear) dysfunction is a cause for poor balance in Parkinson Disease (PD), and whether inner ear stimulation with a small device may improve balance. This study will involve clinical testing, brain imaging, and an interventional treatment device for symptoms.
Basic testing of participants began in November 2021, but using the device or sham will not begin prior to July 2022.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Treatment 1 | Experimental | Investigational treatment stimulation pattern 1 |
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| Investigational Treatment 2 | Experimental | Investigational treatment stimulation pattern 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non invasive neuromodulation device pattern 1 | Device | The study device consists of a headset, which looks like a music earphone headset, and a base station that powers the headset. The headset has metallic earpieces that fit into the ear canals. When activated, the study device will deliver a prescribed stimulation pattern for approximately 20 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Freezing of Gait | Freezing of Gait is measured by the New Freezing of Gate Questionnaire, the current gold standard for assessment of FoG in Parkinsons Disease. Measured on a scale of 0 - 28 points with higher numbers representing more severe freezing of gait | after a week of treatment |
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Inclusion Criteria:
1. Parkinson disease duration of 5 years or more or Hoehn & Yahr stage 1.5-4
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chatkaew Pongmala, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48106 | United States |
Per the informed consent, which allows for opt-out of data sharing, some of the observational research data and brain images collected in this study (collectively referred to as "research data") may be shared with University of Michigan investigators, investigators from outside of the University of Michigan, or may be submitted to data repositories with permission from the participant. Representatives of the Study Device Sponsor may have access to participant data but will not share it.
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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 | May 15, 2025 | Dec 3, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Ann Arbor VA | Dec 18, 2025 | Feb 11, 2026 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: University of Michigan | Nov 13, 2025 | Dec 3, 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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| Non invasive neuromodulation device pattern 2 | Device | The study device consists of a headset, which looks like a music earphone headset, and a base station that powers the headset. The headset has metallic earpieces that fit into the ear canals. When activated, the study device will deliver a prescribed stimulation pattern for approximately 20 minutes. |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |