Posttraumatic Stress DisorderNCT02154009
Clinical Autonomic Disorders: A Training Protocol
An observational study of Posttraumatic Stress Disorder and Pseudopheochromocytoma, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: The autonomic nervous system helps control things that happen automatically in the body, like blood pressure, heart rate, and digestion. When it doesn t work properly, it s called dysautonomia. Researchers want to learn more about dysautonomias and train doctors to learn how to better diagnose them. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder, Pseudopheochromocytoma, Healthy Volunteers
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2014to 7 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Referred patients with known or suspected abnormalities of one or more components of the autonomic nervous system and healthy adult volunteers. Volunteers will be studied for Fellows to practice and gain normative values for pupillometric function.
Who may be able to join
- Patients may be included if they are at least 18 years old and are known or suspected to have failure of one or more components of the autonomic nervous system, small fiber neuropathy, inherited dysautonomia, orthostatic intolerance, neurocardiogenic syncope, status post endoscopic thoracic sympathectomy, or disorders of catecholamine synthesis or fate.
- Children greater than two years old may be enrolled in this Protocol if they might personally benefit from the tests in the Protocol through the establishment of a diagnosis.
- Healthy adult Volunteers (at least 18 years old) may be included, pending normal or medically insignificant results of history and physical examination. A repeat history and physical examination is required if more than 6 months have gone by from a previous workup.
Who cannot join
- There are no exclusion criteria for the study as a whole.
- A candidate Healthy Volunteer will be excluded if the person has any of the following: symptoms of autonomic dysfunction, including lightheadedness, fainting, abnormalities of sweating, frequent nausea, vomiting, constipation, or diarrhea, or urinary frequency or retention. If the Volunteer has a condition requiring medication that in the judgment of the Investigators will affect results of the pupillometric tests under this Protocol, the Volunteer may be included for training purposes.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- The autonomic nervous system helps control things that happen automatically in the body, like blood pressure, heart rate, and digestion. When it doesn t work properly, it s called dysautonomia. Researchers want to learn more about dysautonomias and train doctors to learn how to better diagnose them.
Read more
Objectives:
- To allow people with autonomic disorders to be evaluated.
- To help fellows in the NIH Autonomic Disorders fellowship program see a variety of diseases in their training.
Eligibility:
- People age 18 and older with dysautonomia; children over age 2 if they might benefit
- Healthy adult volunteers
Design:
- Participants will have different procedures depending on their symptoms. They will have one or more visits. They will have some but not all of the tests below.
- Participants will have a medical history and physical exam. They may be tested for problems thinking. They may complete a symptom questionnaire. They may have their temperature and blood pressure taken.
- Participants may have an intravenous line placed. A needle will guide a thin plastic tube into an arm vein.
- Participants may have blood drawn several times. They may give a urine sample.
- Participants may have an electrocardiogram.
- How much blood a participant s heart is pumping and/or how much blood is flowing through their arm may be measured. The total amount of blood in their bloodstream may be measured.
- Participants may have their ability to sweat and/or sense of smell tested.
- Breathing, bowel sounds, and/or body functions may be monitored.
- Pupil size, response to environmental temperature changes, and/or breathing may be measured.
- Participants may have a bladder ultrasound.
- Small pieces of skin may be taken for study.
Read the detailed description
Objective:
This Protocol is to facilitate training of Fellows in evaluation of clinical disorders of the autonomic nervous system. The training is necessary to enable Fellows to sit for and pass the certifying examination in autonomic disorders administered by the United Council for Neurologic Subspecialties (UCNS) and to maintain UCNS accreditation of the Fellowship. A secondary objective is to include results of evaluations and testing with those from other Protocols, for future data analyses.
Study population:
Referred patients with known or suspected abnormalities of one or more components of the autonomic nervous system and healthy adult volunteers. Volunteers will be studied for Fellows to practice and gain normative values for pupillometric function.
Design:
Clinical physiologic, neuropharmacologic, and neurochemical testing will be performed during outpatient clinic visits or during inpatient admissions, depending on the individual testing schedule. Inpatient testing may be done in conjunction with other Protocols (e.g., 03-N-0004). Most of the testing under this Protocol can be completed in a single outpatient visit over the course of a workday. Testing procedures under this Protocol will be performed as needed for adequate Fellow training. In addition to autonomic medical history and physical examination, clinical testing procedures may include (A) monitoring of hemodynamics, sweating, and other physiologic parameters associated with the Valsalva maneuver, orthostasis, or external temperature manipulation; (B) venous blood sampling for assays of levels of catecholamines and related neurochemicals; (C) administration of autonomic test drugs; (D) skin biopsies; (E) blood volume measurement; (F) pupillometry; (G) gastrointestinal phonography; (H) urinary bladder ultrasound; and (I) neurobehavioral rating scales.
Outcome measures:
The main outcome measure is competency in clinical and laboratory evaluation of autonomic disorders, based on assessment of the Fellow by the Principal Investigator at approximately 6-month intervals. A secondary outcome measure is results obtained under this Protocol, which may be analyzed and reported as research data along with data from other Protocols.
- Conditions
- Posttraumatic Stress Disorder, Pseudopheochromocytoma, Healthy Volunteers, Neurocardiogenic Syncope, Postural Tachycardia Syndrome
- Keywords
- Autonomic Nervous System, Catecholamines, Dysautonomia, Sympathetic Cholinergic System, Sympathetic Adrenergic System
- Medical subject headings
- Stress Disorders, Post-Traumatic, Syncope, Vasovagal, Postural Orthostatic Tachycardia Syndrome, Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Volunteers will be studied for Fellows to practice and gain normative values for pupillometric function. | |
| Patients | Referred patients with known or suspected abnormalities of one or more components of the autonomic nervous system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful completion of the Clinical Fellowship in autonomic disorders
Competency in clinical and laboratory evaluation of autonomic disorders, based on assessment of the Fellow by the Principal Investigator at approximately 6-month intervals
Measured: approximately 6-month intervals.
Secondary outcomes (1)
Clinical samples and data from evaluation of patients with known or suspected autonomic disorders
Analysis of clinical samples and data from evaluation of patients with known or suspected autonomic disorders reported as research data along with data from other Protocols.
Measured: Initial Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study start5 Jun 2014
- Primary completion15 Aug 2019
- Study completion7 Apr 2021
Why it stopped: Training protocol with no research objectives
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David S Goldstein, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154009
- Sponsor's protocol ID
- 140122
- Other IDs
- 14-N-0122
- Status last verified
- Apr 2021
- First submitted
- 31 May 2014
- Last updated
- 8 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Autonomic Disorders: A Training Protocol
- ClinicalTrials.gov ID
- NCT02154009
- Acronym / sponsor ID
- 140122
- Conditions
- Posttraumatic Stress Disorder, Pseudopheochromocytoma, Healthy Volunteers, Neurocardiogenic Syncope, Postural Tachycardia Syndrome
- Keywords
- Autonomic Nervous System, Catecholamines, Dysautonomia, Sympathetic Cholinergic System, Sympathetic Adrenergic System
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Training protocol with no research objectives
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 5 Jun 2014 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 7 Apr 2021 (actual)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- The autonomic nervous system helps control things that happen automatically in the body, like blood pressure, heart rate, and digestion. When it doesn t work properly, it s called dysautonomia. Researchers want to learn more about dysautonomias and train doctors to learn how to better diagnose them.
Objectives:
- To allow people with autonomic disorders to be evaluated.
- To help fellows in the NIH Autonomic Disorders fellowship program see a variety of diseases in their training.
Eligibility:
- People age 18 and older with dysautonomia; children over age 2 if they might benefit
- Healthy adult volunteers
Design:
- Participants will have different procedures depending on their symptoms. They will have one or more visits. They will have some but not all of the tests below.
- Participants will have a medical history and physical exam. They may be tested for problems thinking. They may complete a symptom questionnaire. They may have their temperature and blood pressure taken.
- Participants may have an intravenous line placed. A needle will guide a thin plastic tube into an arm vein.
- Participants may have blood drawn several times. They may give a urine sample.
- Participants may have an electrocardiogram.
- How much blood a participant s heart is pumping and/or how much blood is flowing through their arm may be measured. The total amount of blood in their bloodstream may be measured.
- Participants may have their ability to sweat and/or sense of smell tested.
- Breathing, bowel sounds, and/or body functions may be monitored.
- Pupil size, response to environmental temperature changes, and/or breathing may be measured.
- Participants may have a bladder ultrasound.
- Small pieces of skin may be taken for study.
Detailed description
Objective:
This Protocol is to facilitate training of Fellows in evaluation of clinical disorders of the autonomic nervous system. The training is necessary to enable Fellows to sit for and pass the certifying examination in autonomic disorders administered by the United Council for Neurologic Subspecialties (UCNS) and to maintain UCNS accreditation of the Fellowship. A secondary objective is to include results of evaluations and testing with those from other Protocols, for future data analyses.
Study population:
Referred patients with known or suspected abnormalities of one or more components of the autonomic nervous system and healthy adult volunteers. Volunteers will be studied for Fellows to practice and gain normative values for pupillometric function.
Design:
Clinical physiologic, neuropharmacologic, and neurochemical testing will be performed during outpatient clinic visits or during inpatient admissions, depending on the individual testing schedule. Inpatient testing may be done in conjunction with other Protocols (e.g., 03-N-0004). Most of the testing under this Protocol can be completed in a single outpatient visit over the course of a workday. Testing procedures under this Protocol will be performed as needed for adequate Fellow training. In addition to autonomic medical history and physical examination, clinical testing procedures may include (A) monitoring of hemodynamics, sweating, and other physiologic parameters associated with the Valsalva maneuver, orthostasis, or external temperature manipulation; (B) venous blood sampling for assays of levels of catecholamines and related neurochemicals; (C) administration of autonomic test drugs; (D) skin biopsies; (E) blood volume measurement; (F) pupillometry; (G) gastrointestinal phonography; (H) urinary bladder ultrasound; and (I) neurobehavioral rating scales.
Outcome measures:
The main outcome measure is competency in clinical and laboratory evaluation of autonomic disorders, based on assessment of the Fellow by the Principal Investigator at approximately 6-month intervals. A secondary outcome measure is results obtained under this Protocol, which may be analyzed and reported as research data along with data from other Protocols.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Volunteers will be studied for Fellows to practice and gain normative values for pupillometric function. |
| Patients | – | –Referred patients with known or suspected abnormalities of one or more components of the autonomic nervous system |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Referred patients with known or suspected abnormalities of one or more components of the autonomic nervous system and healthy adult volunteers. Volunteers will be studied for Fellows to practice and gain normative values for pupillometric function.
Key inclusion criteria (3 listed)
- Patients may be included if they are at least 18 years old and are known or suspected to have failure of one or more components of the autonomic nervous system, small fiber neuropathy, inherited dysautonomia, orthostatic intolerance, neurocardiogenic syncope, status post endoscopic thoracic sympathectomy, or disorders of catecholamine synthesis or fate.
- Children greater than two years old may be enrolled in this Protocol if they might personally benefit from the tests in the Protocol through the establishment of a diagnosis.
- Healthy adult Volunteers (at least 18 years old) may be included, pending normal or medically insignificant results of history and physical examination. A repeat history and physical examination is required if more than 6 months have gone by from a previous workup.
Key exclusion criteria (2 listed)
- There are no exclusion criteria for the study as a whole.
- A candidate Healthy Volunteer will be excluded if the person has any of the following: symptoms of autonomic dysfunction, including lightheadedness, fainting, abnormalities of sweating, frequent nausea, vomiting, constipation, or diarrhea, or urinary frequency or retention. If the Volunteer has a condition requiring medication that in the judgment of the Investigators will affect results of the pupillometric tests under this Protocol, the Volunteer may be included for training purposes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Successful completion of the Clinical Fellowship in autonomic disorders
Time frame: approximately 6-month intervals.
Competency in clinical and laboratory evaluation of autonomic disorders, based on assessment of the Fellow by the Principal Investigator at approximately 6-month intervals
1 secondary outcome
Clinical samples and data from evaluation of patients with known or suspected autonomic disorders
Time frame: Initial Visit
Results and safety
The study was stopped early (reason given: Training protocol with no research objectives). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Goldstein, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posttraumatic Stress Disorder and Pseudopheochromocytoma, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Training protocol with no research objectives). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful completion of the Clinical Fellowship in autonomic disorders (time frame: approximately 6-month intervals.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.