Gulf War SyndromeSTARTNCT03560830
START & STOPP in GWI
An observational study of Gulf War Syndrome, run by Georgetown University at 1 site in United States.
Trial summary
Gulf War Illness (GWI) veterans were divided into 2 pathophysiological groups based on their orthostatic tachycardia responses after submaximal exercise. Two thirds had normal increases of 10 to 15 beats per minute between recumbent and standing both before and after exercise. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gulf War Syndrome
- What is being tested?
- 2 submaximal exercise stress tests
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 18 Jun 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Gulf War Illness subjects had to be in the US military for at least 30 days between August 1, 1990 and July 31, 1991, deployed to the Persian Gulf, and to meet the "Kansas" criteria for Gulf War Illness.
Who may be able to join
- Gulf War Illness subjects: "Kansas" criteria of Lea Steele (2000). Healthy Veterans: Have never met criteria for GWI, Chronic Multisymptom Illness (CMI), or any of the other related conditions.
- All subjects: A score of 24 or more on the Mini Mental Status Examination.
Who cannot join
- HIV / AIDS subjects Pregnant women. Active duty military personnel. Children under age of 18 years Incarcerated people (in jail) Cognitive impairment such as mental retardation, severe head injury, stroke, proven multiple sclerosis, "melancholic" suicidal major depression, schizophrenia, dementia, Alzheimer disease, Parkinson's disease, brain injury, severe head injury, bleeding into brain, have been unconscious for more than 1 day (in a coma), seizures, multiple sclerosis, or other serious neurological disease.
- Metal implants such as prostheses, wires, plates, or screws that may heat up in the magnetic resonance imaging scanner and cause harm.
- Claustrophobia. Abnormal laboratory and questionnaire results. Heart, lung, kidney, arthritis, autoimmune, cancer, and other chronic illnesses, leg amputations, heart attacks (myocardial infarction), coronary artery disease, abnormal heart rhythms, uncontrolled high blood pressure or strokes, lung disease from smoking or other causes, painful, swollen or deformed joints related to arthritis or autoimmune diseases, weakness from nerve damage, liver disease (alcoholic cirrhosis), inflammatory bowel disease (Crohn's disease, ulcerative colitis), or cancer Medications. Drugs that interfere with heart, lung, brain and nerve function Problems Drawing Blood.
- Subjects may participate if they have well controlled diabetes or thyroid disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University
Washington D.C., District of Columbia, 20007-2197
About this study
Official title: START & STOPP in GWI Stress Test Activated Reversible Tachycardia & Stress Test Originated Phantom Perception in Gulf War Illness
Gulf War Illness (GWI) veterans were divided into 2 pathophysiological groups based on their orthostatic tachycardia responses after submaximal exercise. Two thirds had normal increases of 10 to 15 beats per minute between recumbent and standing both before and after exercise. These were termed the Stress Test Originated Phantom Perception (STOPP) phenotype. In contrast, one third had increases in heart rate of more than 30 beats per minute indicating that exercise induced postural tachycardia; there were the Stress Test Activated Reversible Tachycardia (START) group. This study aimed to confirm the original findings of Rayhan (2013).
Read the detailed description
Gulf War Illness (GWI) veterans had heart rate and blood pressure measured lying down, and then for 5 minutes standing up. Before exercise, all GWI had normal changes of 10 to 15 beats per minute upon standing up. Then they had submaximal bicycle exercise stress tests. Rayhan et al. (2013) discovered that two thirds of the subjects had the same, unchanged response of about 10 to 15 beats per minute upon standing both before and after exercise. These were termed the Stress Test Original Phantom Perception (STOPP) phenotype. In contrast, one third of GWI veterans were found to have normal postural changes before exercise, but all the stress tests they had larger changes in heart rate of over 30 beats per minute. They were termed the Stress Test Activated Reversible Tachycardia (START) phenotype.
The importance of the START phenotype was indicated by finding that they had brain stem atrophy by MRI voxel based morphometry, reduced brain blood flow and activation during a cognitive task performed in the fMRI scanner, and differences in biomarkers compared to STOPP and sedentary control subjects.
This study was designed to use the identical exercise protocol to verify or refute the presence of START and STOPP phenotypes in GWI.
The incremental change in heart rate between recumbent and standing (Delta HR) was determined by having subjects lie quietly at rest. Heart rate and blood pressure was measured at 1 minute intervals. The average recumbent heart rate was determined. Then subjects stood up without assistance. Beginning 1 minute after standing up, heart rate was measured at 1 minute intervals for 5 minutes. Delta HR was found by subtracting each of the 5 standing measurements minus the average recumbent heart rate. If a subject had 2 or more Delta HR measurements of 30 beats per minute or greater while standing, they were called Stress Test Activated Reversible Tachycardia (START).
The threshold of 30 beats per minute for Delta HR was based on the criteria for Postural Orthostatic Tachycardia Syndrome (POTS). However, START subjects had normal Delta HR of 10 to 15 before exercise, and so did not have POTS. This was a key finding of the original study that we plan to verify in this study.
Study Design:
Pre-exercise recumbent and standing heart rate measurements and m Magnetic resonance imaging (MRI).
Exercise: Submaximal bicycle exercise stress test. Subjects were monitored while sitting on the bike for 5 minutes. Cycling started with a gradual increase in resistance to increase heart rate to 70% of maximum predicted heart rate (pHR = 220-Age). Cycling continued at 70%pHR for 25 minutes or until the subject wanted to stop. After 25 minutes, the exercise level was increased gradually to reach 85%pHR equivalent to a cardiac stress test. After stopping, heart rate was measured for 5 more minutes while sitting.
Post-Exercise: Recumbent and standing heart rate measurements were performed approximately 3, 8, 24 and 36 hours after exercise. Specific times could not be scheduled because of the timing of MRI scans and other procedures.
Outcome measure: DeltaHR was the difference between standing heart rates minus average recumbent heart rate. Changes in DeltaHR were measured for up to 48 hr after exercise.
START definition: DeltaHR of 30 more greater at 2 or more time points in the 48 hr after submaximal exercise.
- Conditions
- Gulf War Syndrome
- Being tested
- 2 submaximal exercise stress tests
- Medical subject headings
- Persian Gulf Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 submaximal exercise stress testsOther
| Study group | Role | What they receive |
|---|---|---|
| Control | Sedentary control subjects with no medical or psychiatric disorder Receives: Other: 2 submaximal exercise stress tests | |
| POTS GWI | GWI with Postural Orthostatic Tachycardia Syndrome (POTS) GWI veterans who had postural orthostatic tachycardia before exercise and after 2 submaximal exercise stress tests. Postural orthostatic tachycardia was defined by 2015 Consensus as an increase in heart rate of greater than or equal to 30 beats per minute between recumbent (after 5 minutes of rest) and standing up. Standing heart rates were measured every minute for 5 minutes. Postural orthostatic tachycardia was defined if the change in heart rate was more than 30 beats per minute at at least 2 of the 5 standing time points. The average change in heart rate did not have to be above 30. There were 11 GWI POTS subjects. Receives: Other: 2 submaximal exercise stress tests | |
| START | START = Stress Test Activated Reversible Tachycardia One third of GWI veterans were found to have normal changes in heart rate between recumbent and standing (usual change ~10 to 15 beats per minute) BEFORE EXERCISE, but AFTER EXERCISE (submaximal exercise stress tests) they developed postural orthostatic tachycardia with changes in heart rate of 30 or more between recumbent and standing. The effect was transient as it lasted about 36 to 48 hr.
The START group had brainstem atrophy and reduced brain activation during a cognitive task compared to sedentary control and other GWI subjects. Receives: Other: 2 submaximal exercise stress tests | |
| STOPP | STOPP = Stress Test Originated Phantom Perception Two thirds of GWI veterans were found to have normal changes in heart rate between recumbent and standing (usual change ~10 to 15 beats per minute) both before and after 2 submaximal exercise stress tests. STOPP did not develop postural orthostatic tachycardia. their changes were equivalent to the sedentary control group.
The STOPP group increased brain activation of the basal ganglia and anterior insula during a cognitive task compared to sedentary control subjects. Receives: Other: 2 submaximal exercise stress tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
START Phenotype
Delta heart rate (deltaHR) greater than 30 beats per minute within 48 hr of performing submaximal exercise stress test
Measured: 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study startFeb 2016
- Primary completion30 Jun 2018
- Study completion18 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gulf War SyndromeStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Baraniuk, MD, Georgetown University
- Investigators
- James N Baraniuk, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560830
- Sponsor's protocol ID
- 2015-0579
- Acronym
- START
- Status last verified
- Jun 2019
- First submitted
- 18 Apr 2018
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A manuscript is being written to describe the protocol and outcomes
Publications
Baraniuk JN, Shivapurkar N. Exercise - induced changes in cerebrospinal fluid miRNAs in Gulf War Illness, Chronic Fatigue Syndrome and sedentary control subjects. Sci Rep. 2017 Nov 10;7(1):15338. doi: 10.1038/s41598-017-15383-9.
PubMed 29127316Rayhan RU, Washington SD, Garner R, Zajur K, Martinez Addiego F, VanMeter JW, Baraniuk JN. Exercise challenge alters Default Mode Network dynamics in Gulf War Illness. BMC Neurosci. 2019 Feb 21;20(1):7. doi: 10.1186/s12868-019-0488-6.
PubMed 30791869Garner RS, Rayhan RU, Baraniuk JN. Verification of exercise-induced transient postural tachycardia phenotype in Gulf War Illness. Am J Transl Res. 2018 Oct 15;10(10):3254-3264. eCollection 2018.
PubMed 30416666Baraniuk JN, Shivapurkar N. Author Correction: Exercise - induced changes in cerebrospinal fluid miRNAs in Gulf War Illness, Chronic Fatigue Syndrome and sedentary control subjects. Sci Rep. 2018 Apr 19;8(1):6455. doi: 10.1038/s41598-018-23238-0.
PubMed 29674668Rayhan RU, Ravindran MK, Baraniuk JN. Migraine in gulf war illness and chronic fatigue syndrome: prevalence, potential mechanisms, and evaluation. Front Physiol. 2013 Jul 24;4:181. doi: 10.3389/fphys.2013.00181. eCollection 2013.
PubMed 23898301
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- START & STOPP in GWI Stress Test Activated Reversible Tachycardia & Stress Test Originated Phantom Perception in Gulf War Illness
- ClinicalTrials.gov ID
- NCT03560830
- Acronym / sponsor ID
- START / 2015-0579
- Conditions
- Gulf War Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 18 Jun 2018 (actual)
- 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.
Gulf War Illness (GWI) veterans were divided into 2 pathophysiological groups based on their orthostatic tachycardia responses after submaximal exercise. Two thirds had normal increases of 10 to 15 beats per minute between recumbent and standing both before and after exercise. These were termed the Stress Test Originated Phantom Perception (STOPP) phenotype. In contrast, one third had increases in heart rate of more than 30 beats per minute indicating that exercise induced postural tachycardia; there were the Stress Test Activated Reversible Tachycardia (START) group. This study aimed to confirm the original findings of Rayhan (2013).
Detailed description
Gulf War Illness (GWI) veterans had heart rate and blood pressure measured lying down, and then for 5 minutes standing up. Before exercise, all GWI had normal changes of 10 to 15 beats per minute upon standing up. Then they had submaximal bicycle exercise stress tests. Rayhan et al. (2013) discovered that two thirds of the subjects had the same, unchanged response of about 10 to 15 beats per minute upon standing both before and after exercise. These were termed the Stress Test Original Phantom Perception (STOPP) phenotype. In contrast, one third of GWI veterans were found to have normal postural changes before exercise, but all the stress tests they had larger changes in heart rate of over 30 beats per minute. They were termed the Stress Test Activated Reversible Tachycardia (START) phenotype.
The importance of the START phenotype was indicated by finding that they had brain stem atrophy by MRI voxel based morphometry, reduced brain blood flow and activation during a cognitive task performed in the fMRI scanner, and differences in biomarkers compared to STOPP and sedentary control subjects.
This study was designed to use the identical exercise protocol to verify or refute the presence of START and STOPP phenotypes in GWI.
The incremental change in heart rate between recumbent and standing (Delta HR) was determined by having subjects lie quietly at rest. Heart rate and blood pressure was measured at 1 minute intervals. The average recumbent heart rate was determined. Then subjects stood up without assistance. Beginning 1 minute after standing up, heart rate was measured at 1 minute intervals for 5 minutes. Delta HR was found by subtracting each of the 5 standing measurements minus the average recumbent heart rate. If a subject had 2 or more Delta HR measurements of 30 beats per minute or greater while standing, they were called Stress Test Activated Reversible Tachycardia (START).
The threshold of 30 beats per minute for Delta HR was based on the criteria for Postural Orthostatic Tachycardia Syndrome (POTS). However, START subjects had normal Delta HR of 10 to 15 before exercise, and so did not have POTS. This was a key finding of the original study that we plan to verify in this study.
Study Design:
Pre-exercise recumbent and standing heart rate measurements and m Magnetic resonance imaging (MRI).
Exercise: Submaximal bicycle exercise stress test. Subjects were monitored while sitting on the bike for 5 minutes. Cycling started with a gradual increase in resistance to increase heart rate to 70% of maximum predicted heart rate (pHR = 220-Age). Cycling continued at 70%pHR for 25 minutes or until the subject wanted to stop. After 25 minutes, the exercise level was increased gradually to reach 85%pHR equivalent to a cardiac stress test. After stopping, heart rate was measured for 5 more minutes while sitting.
Post-Exercise: Recumbent and standing heart rate measurements were performed approximately 3, 8, 24 and 36 hours after exercise. Specific times could not be scheduled because of the timing of MRI scans and other procedures.
Outcome measure: DeltaHR was the difference between standing heart rates minus average recumbent heart rate. Changes in DeltaHR were measured for up to 48 hr after exercise.
START definition: DeltaHR of 30 more greater at 2 or more time points in the 48 hr after submaximal exercise.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: 2 submaximal exercise stress testsSedentary control subjects with no medical or psychiatric disorder |
| POTS GWI | – | Other: 2 submaximal exercise stress testsGWI with Postural Orthostatic Tachycardia Syndrome (POTS) GWI veterans who had postural orthostatic tachycardia before exercise and after 2 submaximal exercise stress tests. Postural orthostatic tachycardia was defined by 2015 Consensus as an increase in heart rate of greater than or equal to 30 beats per minute between recumbent (after 5 minutes of rest) and standing up. Standing heart rates were measured every minute for 5 minutes. Postural orthostatic tachycardia was defined if the change in heart rate was more than 30 beats per minute at at least 2 of the 5 standing time points. The average change in heart rate did not have to be above 30. There were 11 GWI POTS subjects. |
| START | – | Other: 2 submaximal exercise stress testsSTART = Stress Test Activated Reversible Tachycardia One third of GWI veterans were found to have normal changes in heart rate between recumbent and standing (usual change ~10 to 15 beats per minute) BEFORE EXERCISE, but AFTER EXERCISE (submaximal exercise stress tests) they developed postural orthostatic tachycardia with changes in heart rate of 30 or more between recumbent and standing. The effect was transient as it lasted about 36 to 48 hr. The START group had brainstem atrophy and reduced brain activation during a cognitive task compared to sedentary control and other GWI subjects. |
| STOPP | – | Other: 2 submaximal exercise stress testsSTOPP = Stress Test Originated Phantom Perception Two thirds of GWI veterans were found to have normal changes in heart rate between recumbent and standing (usual change ~10 to 15 beats per minute) both before and after 2 submaximal exercise stress tests. STOPP did not develop postural orthostatic tachycardia. their changes were equivalent to the sedentary control group. The STOPP group increased brain activation of the basal ganglia and anterior insula during a cognitive task compared to sedentary control subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Gulf War Illness subjects had to be in the US military for at least 30 days between August 1, 1990 and July 31, 1991, deployed to the Persian Gulf, and to meet the "Kansas" criteria for Gulf War Illness.
Key inclusion criteria (2 listed)
- Gulf War Illness subjects: "Kansas" criteria of Lea Steele (2000). Healthy Veterans: Have never met criteria for GWI, Chronic Multisymptom Illness (CMI), or any of the other related conditions.
- All subjects: A score of 24 or more on the Mini Mental Status Examination.
Key exclusion criteria (4 listed)
- HIV / AIDS subjects Pregnant women. Active duty military personnel. Children under age of 18 years Incarcerated people (in jail) Cognitive impairment such as mental retardation, severe head injury, stroke, proven multiple sclerosis, "melancholic" suicidal major depression, schizophrenia, dementia, Alzheimer disease, Parkinson's disease, brain injury, severe head injury, bleeding into brain, have been unconscious for more than 1 day (in a coma), seizures, multiple sclerosis, or other serious neurological disease.
- Metal implants such as prostheses, wires, plates, or screws that may heat up in the magnetic resonance imaging scanner and cause harm.
- Claustrophobia. Abnormal laboratory and questionnaire results. Heart, lung, kidney, arthritis, autoimmune, cancer, and other chronic illnesses, leg amputations, heart attacks (myocardial infarction), coronary artery disease, abnormal heart rhythms, uncontrolled high blood pressure or strokes, lung disease from smoking or other causes, painful, swollen or deformed joints related to arthritis or autoimmune diseases, weakness from nerve damage, liver disease (alcoholic cirrhosis), inflammatory bowel disease (Crohn's disease, ulcerative colitis), or cancer Medications. Drugs that interfere with heart, lung, brain and nerve function Problems Drawing Blood.
- Subjects may participate if they have well controlled diabetes or thyroid disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 submaximal exercise stress tests | Other | Control, POTS GWI, START, STOPP |
Primary outcome
START Phenotype
Time frame: 48 hour
Delta heart rate (deltaHR) greater than 30 beats per minute within 48 hr of performing submaximal exercise stress test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Background: PubMed 29127316Baraniuk JN, Shivapurkar N. Exercise - induced changes in cerebrospinal fluid miRNAs in Gulf War Illness, Chronic Fatigue Syndrome and sedentary control subjects. Sci Rep. 2017 Nov 10;7(1):15338. doi: 10.1038/s41598-017-15383-9.
- Results publication: PubMed 30791869Rayhan RU, Washington SD, Garner R, Zajur K, Martinez Addiego F, VanMeter JW, Baraniuk JN. Exercise challenge alters Default Mode Network dynamics in Gulf War Illness. BMC Neurosci. 2019 Feb 21;20(1):7. doi: 10.1186/s12868-019-0488-6.
- Results publication: PubMed 30416666Garner RS, Rayhan RU, Baraniuk JN. Verification of exercise-induced transient postural tachycardia phenotype in Gulf War Illness. Am J Transl Res. 2018 Oct 15;10(10):3254-3264. eCollection 2018.
- Results publication: PubMed 29674668Baraniuk JN, Shivapurkar N. Author Correction: Exercise - induced changes in cerebrospinal fluid miRNAs in Gulf War Illness, Chronic Fatigue Syndrome and sedentary control subjects. Sci Rep. 2018 Apr 19;8(1):6455. doi: 10.1038/s41598-018-23238-0.
- Results publication: PubMed 23898301Rayhan RU, Ravindran MK, Baraniuk JN. Migraine in gulf war illness and chronic fatigue syndrome: prevalence, potential mechanisms, and evaluation. Front Physiol. 2013 Jul 24;4:181. doi: 10.3389/fphys.2013.00181. eCollection 2013.
- Individual participant dataSharing planned: Yes. A manuscript is being written to describe the protocol and outcomes
Related trials for Gulf War Syndrome
Not yet recruiting
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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.
James N Baraniuk principal investigator
Georgetown University
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 Gulf War Syndrome, run by Georgetown University 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 20 Jun 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
START Phenotype (time frame: 48 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03560830, which also lists 5 linked publications.
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 20 Jun 2019.