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Vagus Nerve Stimulation + Physical Therapy for Parkinson's Disease (VNS-PT-PD Trial)
N/A
Recruiting
Led By Alexandra Evancho, DPT
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
VNS-PT-PD Trial Summary
This trial will assess if non-invasive stimulation and exercise can improve the lives of those with Parkinson's Disease.
Who is the study for?
This trial is for people aged 35-80 with Parkinson's Disease who can walk without aids, have stable medication use, and haven't fallen in the past 6 months. They need a doctor's approval to participate and must not have cognitive impairments or certain medical conditions that could affect the study.Check my eligibility
What is being tested?
The study tests how non-invasive Vagus Nerve Stimulation (taVNS), paired with exercise, affects physical function and life quality in Parkinson's patients. It aims to see if this combination therapy offers any benefits over standard care.See study design
What are the potential side effects?
Potential side effects of taVNS may include mild discomfort at the stimulation site, headache, voice changes due to laryngeal muscle stimulation, or short-term changes in heart rate or blood pressure.
VNS-PT-PD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
10MWT
6MWT
FGA
+3 moreSecondary outcome measures
DKEFS Color Word Interference Test
DKEFS Trails Making Test (Trails)
DKEFS Verbal Learning Test (VLT)
+7 moreVNS-PT-PD Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: active taVNS + exerciseExperimental Treatment2 Interventions
Participants who are randomized into the active taVNS + exercise group will receive 15 minutes of active taVNS prior to exercise sessions.
Group II: sham taVNS + exercisePlacebo Group1 Intervention
Participants who are randomized into the sham taVNS + exercise group will receive 0 mA of current for 15 minutes prior to exercise sessions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise
2016
Completed Phase 1
~760
taVNS
2011
Completed Phase 4
~250
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,622 Total Patients Enrolled
Alexandra Evancho, DPTPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not use any walking aids.I can move well enough to do intense physical therapy.I have a history of seizures.I feel persistently sad or have been diagnosed with depression.I am taking medication for depression or psychosis.I am between 35 and 80 years old.I have no heart, nerve, or muscle disorders that affect movement tests.I have not fallen in the last 6 months.I have nerve issues such as jaw pain or facial paralysis.I have fainted due to a sudden drop in heart rate and blood pressure.My medications have been the same for the last 4 weeks and will not change during the study.
Research Study Groups:
This trial has the following groups:- Group 1: sham taVNS + exercise
- Group 2: active taVNS + exercise
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you confirm if the eligibility criterion for this trial encompasses individuals over 20 years old?
"This medical trial is recruiting individuals aged 35 and above, but below 80 years old."
Answered by AI
What criteria must be met to partake in this clinical trial?
"The prerequisites for this trial involve the diagnosis of Parkinson's disease as well as an age range between 35 and 80 years old. As such, 40 participants need to be selected in total."
Answered by AI
What is the primary goal of this clinical trial?
"This 8-week long medical study aims to assess a 6MWT. Secondary objectives include evaluations of cognitive functioning with the DKEFS, HVLT, and DSMT measures."
Answered by AI
Are persons still welcome to join this clinical experiment?
"According to clinicaltrials.gov, this research project is not presently searching for candidates. Initially posted on June 1st 2023 and last updated May 12th 2023, the study has yet to initiate recruitment; however, there are currently 515 other studies that are actively recruiting patients at this time."
Answered by AI
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