Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06642454
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-13
Brief Title:
A Comparative Open-Label Crossover Study of Respiratory-Gated Versus Non-Respiratory-Gated Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Non-Motor Symptoms in Parkinsons Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Comparative Open-Label Crossover Study of Respiratory-Gated Versus Non-Respiratory-Gated Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Non-Motor Symptoms in Parkinsons Disease
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The goal of this clinical trial is to compare the effects of different modes and frequencies of transcutaneous auricular vagus nerve stimulation taVNS on non-motor symptoms in people with Parkinsons disease The main questions it aims to answer are
Which mode and frequency of taVNS is most effective in improving non-motor symptoms Are there any side effects or safety concerns with different taVNS frequencies Researchers will compare three types of taVNS 25 Hz non-expiratory gated 25 Hz expiratory gated and 100 Hz expiratory gated stimulation
Participants will
Receive each type of taVNS in three 2-week cycles with 2-month breaks between cycles Undergo neuropsychological assessments imaging eye-tracking and biological sample collection before and after each cycle
Which mode and frequency of taVNS is most effective in improving non-motor symptoms Are there any side effects or safety concerns with different taVNS frequencies Researchers will compare three types of taVNS 25 Hz non-expiratory gated 25 Hz expiratory gated and 100 Hz expiratory gated stimulation
Participants will
Receive each type of taVNS in three 2-week cycles with 2-month breaks between cycles Undergo neuropsychological assessments imaging eye-tracking and biological sample collection before and after each cycle
Detailed Description:
This study employs a three-cycle crossover design to compare the effects of three different modes and frequencies of transcutaneous auricular vagus nerve stimulation taVNS The interventions include 25 Hz non-expiratory gated taVNS 25 Hz expiratory gated taVNS and 100 Hz expiratory gated taVNS Participants will be randomly assigned to one of three groups with each group receiving a different intervention during each cycle lasting 2 weeks per cycle A 2-month washout period will be implemented between cycles to eliminate any carryover effectsThe study design will include neuropsychological assessments imaging eye-tracking data collection and biological specimen collection before and after each intervention
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