Trial · NCT06953661
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | COMPASS 31 total score | Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention) | The change in Composite Autonomic Symptom Score 31 (COMPASS-31) from baseline to first follow-up visit. The COMPASS-31 scale measures autonomic dysfunctions through 31 patient-reported questions. A higher score indicates worse autonomic dysfunction. |
| Secondary | Magnitude of postural tachycardia | Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention) | Change in magnitude of postural tachycardia (a heart rate increase within the first 10 minutes of standing) from baseline to first and second follow up visit. |
| Secondary | Heart rate variability (HRV) | Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention) | Change in heart rate variability (HRV) metrics (time and frequency domains) from baseline to first and second follow up visit |
| Secondary | Plasma catecholamine levels | Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention) | Measure the change in plasma catecholamine levels from baseline to first and second follow up visits |
| Secondary | Survey of Postural Orthostatic Tachycardia Syndrome Symptoms (SPOTS) | Baseline (day -21 to -1 before intervention) to 1-2 weeks, then day 74 to 94 following study intervention | SPOTS evaluates the frequency and severity of common POTS symptoms, The higher the score, the greater the symptom burden. A reduction in SPOTS score suggests clinical improvement. SPOTS scores at 1st and 2nd FU are compared to baseline SPOTS scores. |
| Secondary | VOSS score | Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention) | Change in VOSS score at 1st and 2nd FU compared to baseline. The Vanderbilt Orthostatic Symptom Score (VOSS) is a tool used to assess and track the severity of symptoms associated with postural orthostatic tachycardia syndrome (POTS). It helps quantify a patient's symptom burden by having them rate the severity of 9 symptoms (mental clouding, blurred vision, shortness of breath, rapid heartbeat, tremulousness, chest discomfort, headache, lightheadedness, and nausea) on a scale of 0 to 10, where 0 indicates no symptoms. |
| Secondary | FSS score | Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention) | Change in FSS score at 1st and 2nd FU compared to baseline. The Fatigue Severity Scale (FSS) is a questionnaire used to measure the severity of fatigue and its impact on daily activities. It's a 9-item scale where respondents rate their agreement with statements about fatigue using a 7-point scale, with 1 being "strongly disagree" and 7 being "strongly agree". The total FSS score is calculated by summing the responses, with a higher score indicating greater fatigue severity. |
| Secondary | PROMIS Cognitive Function Short Form 6a | Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention) | Change in the PROMIS Cognitive Function Short Form 6a score at 1st and 2nd FU compared to baseline. Short Form 6a is a six-item sub-set scale of the PROMIS (Patient Reported Outcomes Measurement Information System) Cognitive Function item bank that assesses patient-perceived cognitive deficits. The questions use a 5-point response scale, ranging from "Not at all" to "Very much". A higher score generally indicates better perceived cognitive ability. |
| Secondary | EQ-5D score | Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention) | Change in EQ-5D score at 1st and 2nd FU compared to baseline. The EQ-5D is a questionnaire for measuring patient-reported outcomes which assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D index score ranges from 0 to 1, where 1 represents perfect health, 0 represents a state as bad as death, and values between 0 and 1 represent different levels of health, with higher values indicating better health. |
| Secondary | PGI-S rating | Baseline (day -21 to -1 before intervention) | The PGI-S (Patient Global Impression of Severity) is a single-item, 7-point scale used to assess a patient's perception of the current severity of their condition. A rating of 1 indicates "normal, not at all ill," while a rating of 7 indicates "among the most extremely ill patients." This self-reported measure provides a global assessment of illness severity from the patient's perspective and is commonly used in clinical trials to gauge baseline condition or monitor progression over time. |
| Secondary | PGI-C rating | First follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention) | The PGI-C (Patient Global Impression of Change) is a 7-point scale used to assess a patient's perceived change in their health or condition after an intervention. A rating of 1 indicates "very much improved," while a rating of 7 indicates "very much worse". It's a self-reported measure that reflects a patient's belief about the efficacy of treatment. |
| Secondary | CGI-S rating | Baseline (day -21 to -1 before intervention) | The CGI-S (Clinical Global Impression of Severity) is a 7-point scale used by clinicians to assess the severity of a patient's illness at a given point in time. A rating of 1 indicates "normal, not at all ill," while a rating of 7 indicates "among the most extremely ill patients." This clinician-rated measure provides an overall impression of the patient's current condition, based on clinical judgment and all available information, including patient history, symptoms, and behavior. |
| Secondary | CGI-C rating | First follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention) | The Clinical Global Impression of Change (CGI-C) is a scale used to assess the clinical change or improvement in a patient's condition over time. CGI-C scores range from 1 (very much improved) through to 7 (very much worse). |
| Secondary | BAI score | Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention) | Reduction in anxiety and depression symptoms as measured by the BAI score. Beck Anxiety Inventory (BAI) is a 21-item self-report questionnaire designed to assess the severity of anxiety symptoms. Each item is rated on a 4-point scale (0 = not at all to 3 = severely). The total score ranges from 0 to 63. Higher scores indicate greater severity of anxiety symptoms. |
| Secondary | BDI score | Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention) | Reduction in anxiety and depression symptoms as measured by the BDI score. Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory for measuring the severity of depression. The total score ranges from 0 to 63. Higher total scores indicate more severe depressive symptoms. |
| Secondary | Adrenergic G-protein-coupled receptor autoantibody activity | Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention) | Measure the change in adrenergic G-protein-coupled receptor autoantibody concentrations from baseline to first and second follow up visits from stored serum samples. |
| Secondary | Inflammatory markers (including but not limited to IL1, IL6, IL8, TNF) | Baseline (day -21 to -1 before intervention), first follow-up (day 1 to 21 after the intervention) and second follow-up (day 74 to 94 after the intervention) | Measure the change in inflammatory markers concentrations (including but not limited to IL1, IL6, IL8, TNF) from baseline to first and second follow up visits from stored serum samples |
| Secondary | Horner's syndrome | Within 10 minutes after the procedure | Proportion of patients achieving Horner's syndrome post-SGB as a measure of block success |
| Secondary | Facial skin temperature | Within 10 minutes after the procedure | Measure the change in facial skin temperature (C°) post-procedure |
| Secondary | Facial sweating | Within 10 minutes after the procedure | Sweat testing will be performed following the procedure. The patient is coated with a moisture-sensitive powder that changes color following the increase in facial blood flow following the intervention. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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