Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562569
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
Non-invasive VNS for PD Gait
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Stimulating the Vagus Nerve to Improve Gait in Veterans With Parkinsons Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
More than 110000 US Veterans living with Parkinsons disease PD currently receive PD-related care and services from the VA Fall prevention is a priority for Veterans living PD Gait disturbances are a major cause for functional dependence and the largest risk factor for falls institutionalization and death in PD This SPiRE addresses the need to advance nonpharmacological rehabilitative health care of Veterans and maximizing functional outcomes by developing a non-invasive neuromodulatory transcutaneous cervical Vagal Nerve Stimulation as an at-home intervention to improve gait and balance This pilot clinical trial will assist with future efforts and priorities of the VA to prolong independent living and quality of life by minimizing gait and balance dysfunction experienced by Veterans living with PD
Detailed Description:
More than 110000 US Veterans living with Parkinsons disease PD currently receive PD-related care and services from the VA PD is a complex chronic neurodegenerative multisystem disorder Fall prevention is a priority for Veterans living with PD Gait disturbances are a major cause for functional dependence and the largest risk factor for falls institutionalization and death in PD Gait abnormalities are evident at the time of PD diagnosis and are one of the most disabling features of PD They are also difficult aspects to treat as pharmacologic agents do not address the entire spectrum of gait abnormalities Overall management of PD symptoms can be challenging due to pharmacological interactions and drug side effects Developing a non-pharmacological and non-invasive therapeutic to improve gait and balance is a critical need for Veterans with PD who are managing complex chronic conditions Moreover advancing at-home rehabilitation is ideal for a population of geriatric Veterans who are facing mobility issues managing multiple chronic conditions and who rely on caregiver support Non-invasive cervical Vagal Nerve Stimulation ncVNS may be a solution ncVNS is currently licensed to treat and prevent migraine and other headache syndromes and is covered by the VAH for these indications ncVNS can be self-administered daily at home A hand-held device is used to make contact to the left side of the neck so that the vagal nerve is stimulated ncVNS decreases inflammation and oxidative stress through activation of the cholinergic anti-inflammatory pathway which in turn can contribute to gait improvements in PD One of the most debilitating gait deficits in PD is Freezing of Gait FOG an episodic failure to initiate or maintain walking especially while turning Given that FOG along with falls is related to cholinergic dysfunction both might be reduced following ncVNS Exciting but limited research over the past decade indicates this neuromodulatory approach has the potential to improve gait features in PD The objectives of this SPiRE are to develop a framework for an at-home ncVNS intervention develop an appropriate control intervention for a future larger study and gather preliminary clinical outcome data on PD-specific features The central hypotheses are that i a 4 week at-home active ncVNS intervention and a sham ncVNS control condition will be acceptable and feasible to complete and ii active ncVNS compared to both control ncVNS and treatment as usual TAU will lead to greater improvements in gait FOG balance and fall frequency The proposed study is a pilot prospective parallel group randomized control trial RCT Twenty participants will be randomized to 4 weeks of either active n10 or sham ncVNS n10 A third group n10 will not receive ncVNS but will continue with their treatment as usual TAU The investigators will examine acute cumulative and sustainable effects of ncVNS Advancing non-pharmacologic treatments to improve gait dynamics is a critical need for Veterans with PD Moreover advancing at-home rehabilitation is ideal for a population of geriatric Veterans who are facing multiple issues including mobility This SPiRE is strongly aligned with VA priorities to advance rehabilitative health care of Veterans and restore their physical function to improve QoL If the aims are achieved the investigators will have completed necessary first steps towards developing an at-home easy to use neuromodulatory intervention that should translate to improved gait and balance and contribute to fewer falls This project will yield preliminary data to support a VA Merit and move forward not only the field of noninvasive and nonpharmacological interventions for PD rehabilitation but also the general field of gait and balance rehabilitation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None