Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616363
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Does a Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Nat hx With Its Numerous Co-morbidities
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PAG POTS - NIH Pediatric Postural Orthostatic Tachycardia Syndrome POTS Does a Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities
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:
Postural tachycardia syndrome POTS is a common and disabling disorder among adolescents No epidemiologic data exist to support the often cited 05 to 2 prevalence Case series suggest 3 to 5 times greater incidence in girls than boys POTS is defined in children as daily chronic symptoms of orthostatic intolerance and a 40 bpm rise in heart rate in the first 10 minutes of a tilt study in the absence of orthostatic hypotension POTS often develops after an acute event like an illness infection immunization head trauma psychological trauma or surgery Natural history data are absent for POTS though some outcome studies exist Orthostatic symptoms improve in the majority and heart rate changes improve in 38 at 1 year A 2-year follow up showed small improvement in comorbid symptoms of POTS in a 12 subject cohort followed yearly In a pediatric 5-year outcome follow up questionnaire study 86 of adolescents with POTS reported resolved improved or intermittent symptoms with primarily physical rather than mental health complaints
Detailed Description:
The current definition of POTS highlights the peripheral mechanistic emphasis of 30 years of studies exploring cardio- and cerebro-vascular immunologic mast cell activation connective tissue and other physiologic mechanisms The classification of POTS itself also assumes a peripheral etiology typically including neuropathic hyperadrenergic hypovolemic and sometimes immune POTS However a central nervous system CNS etiology might better account for what is knowns about POTS currently 1 POTS often follows an infection physical or psychological trauma 2 POTS occurs most often in post-menarche adolescent girls volume redistribution differs across subjects 4 exercise cognitive behavioral therapy provide best long-term outcomes 5 co-morbid disorders typically overlapping pain conditions such as migraine headache fibromyalgia and most functional gastrointestinal disorders FGID often dominate the clinical picture COPCs are typically considered to reflect a CNS etiology
Because it coordinates the autonomic motor and pain responses to an acute threat the midbrain periaqueductal gray region PAG is an attractive candidate whose dysfunction could potentially explain all major features of POTS including the frequent antecedent emotional or physical threat the POTS core autonomic changes and the co-morbid pain disorders The PAG interprets threats as escapable or inescapable specifically activating a different column for each response type
Because it coordinates the autonomic motor and pain responses to an acute threat the midbrain periaqueductal gray region PAG is an attractive candidate whose dysfunction could potentially explain all major features of POTS including the frequent antecedent emotional or physical threat the POTS core autonomic changes and the co-morbid pain disorders The PAG interprets threats as escapable or inescapable specifically activating a different column for each response type
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