START & STOPP in GWI

NCT03560830 | Completed

• 1 other identifier: 2015-0579
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Gulf War Syndrome

Outcome Measures

Primary Outcomes (1)

• START Phenotype

  Delta heart rate (deltaHR) greater than 30 beats per minute within 48 hr of performing submaximal exercise stress test

  48 hour

Study Arms (4)

Control

Sedentary control subjects with no medical or psychiatric disorder

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.

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.

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.

Other: 2 submaximal exercise stress tests

Interventions

2 submaximal exercise stress tests OTHER

Control; POTS GWI; START; STOPP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown University

Washington D.C., District of Columbia, 20007-2197, United States

Location

Related Publications (5)

• 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.

  PMID: 29127316 BACKGROUND

• 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.

  PMID: 30791869 RESULT

• 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.

  PMID: 30416666 RESULT

• 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.

  PMID: 29674668 RESULT

• 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.

  PMID: 23898301 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, and buffy coat were collected before exercise, and 1, 4 and 24 hr after exercise. Cerebrospinal fluid was collected after the 2nd exercise stress test Cheek swabs were collected at screening

MeSH Terms

Conditions

Persian Gulf Syndrome

Condition Hierarchy (Ancestors)

Occupational Diseases; War-Related Injuries; Wounds and Injuries

Study Officials

• James N Baraniuk

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: June 18, 2018
• Study Start: February 1, 2016
• Primary Completion: June 30, 2018
• Study Completion: June 18, 2019
• Last Updated: June 20, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2018-2010
• Access Criteria: Open access

Locations

US (1)