Gulf War Syndrome Clinical Trial
— STARTOfficial title:
START & STOPP in GWI Stress Test Activated Reversible Tachycardia & Stress Test Originated Phantom Perception in Gulf War Illness
NCT number | NCT03560830 |
Other study ID # | 2015-0579 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 2016 |
Est. completion date | June 18, 2019 |
Verified date | June 2019 |
Source | Georgetown University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 52 |
Est. completion date | June 18, 2019 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 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. Exclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
United States | Georgetown University | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Georgetown University |
United States,
Baraniuk 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. — View Citation
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. Erratum in: Sci Rep. 2018 Apr 19;8(1):6455. — View Citation
Garner 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. — View Citation
Rayhan 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. — View Citation
Rayhan 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | START Phenotype | Delta heart rate (deltaHR) greater than 30 beats per minute within 48 hr of performing submaximal exercise stress test | 48 hour |
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