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Neuromodulation
LIFU for Autonomic Nervous System Disorders
N/A
Waitlist Available
Research Sponsored by Virginia Polytechnic Institute and State University
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 through study completion, an average of 1 month
Summary
This trial studies how LIFU affects the autonomic nervous system using 3 tests. Physiological recordings will be taken before and after the treatment.
Who is the study for?
This trial is for individuals with autonomic nervous system disorders who don't have claustrophobia, metal implants incompatible with MRI or CT scans, active CNS-affecting medical conditions, a history of significant head injury, substance dependence, or cardiac disease.
What is being tested?
The study tests if Low Intensity Focused Ultrasound (LIFU) targeting specific brain areas affects the body's automatic functions. Participants undergo cold pressor task, valsalva maneuver and deep breathing tasks before and after LIFU to measure changes.
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from the ultrasound procedure or reactions to being in an MRI/CT scan environment due to noise and confinement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Sympathetic tone response - Blood Pressure (BP)
Sympathetic tone response - Electrodermal Response (EDR)
Sympathetic tone response - Electroencephalography (EEG)
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: dPIExperimental Treatment1 Intervention
LIFU to the dPI
Group II: ACCExperimental Treatment1 Intervention
LIFU to the ACC
Group III: ShamPlacebo Group1 Intervention
Sham LIFU application
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Who is running the clinical trial?
Virginia Polytechnic Institute and State UniversityLead Sponsor
153 Previous Clinical Trials
25,025 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a head injury that made me unconscious for more than 10 minutes.I am claustrophobic, which may affect my ability to undergo scans.I have a history of heart disease.I have a condition or am on treatment that affects my brain (like Alzheimer's).I have a neurological condition like Parkinson's, Epilepsy, or Essential Tremor.
Research Study Groups:
This trial has the following groups:- Group 1: ACC
- Group 2: dPI
- Group 3: Sham
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.
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