Long Term Efficacy of Neuronavigation Guided rTMS in Alleviating Gulf War Illness Related Headaches and Pain Symptoms

Headache Clinical Trial

Official title:

Long Term Efficacy of Neuronavigation Guided rTMS in Alleviating Gulf War Illness Related Headaches and Pain Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04182659
• Other study ID #: H190071
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: September 30, 2023

Study information

• Verified date: August 2023
• Source: Veterans Medical Research Foundation
• Contact: Caleb Lopez, BS
• Phone: 858-552-8585
• Email: caleb.lopez[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to look at the long term efficacy of using repetitive transcranial magnetic stimulation (rTMS) in relieving Gulf War Illness related headaches and pain.

Description:

Headaches (HA), muscle and joint pain, are some of the most common debilitating symptoms in military personnel served in the 1990-1991 Persian Gulf War (GW1). Migraine like HA and diffuse body pain were detected in 64% of Gulf War Veteran (GWV) diagnosed with Gulf War Illness (GWI). Unfortunately, conventional pharmacological treatments for GWI-related pain has not been shown to be effective and drugs such as narcotics contain many long term untoward psychosomatic and abusive side effects. This study is assessing the effectiveness of repetitive transcranial magnetic stimulation (rTMS), non-invasive treatment option, in alleviating headaches, muscle, and joint pain symptoms of GWI.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female under 65 years of age who served in the military for at least 30 consecutive days between August 1, 1990, and July 31, 1991 in the Persian Gulf War region

• Center for Disease Control (CDC) Criteria for Gulf War Illness (GWI)

• Kansas Criteria for GWI

• International Headache Society Criteria for Migraine Headache without aura Average Headache Exacerbation Intensity >3 on 0-10 a Numerical Pain Rating scale (NPS)

• Average Overall Daily Muscle Pain Intensity >3 on 0-10 a NPS

• Average Overall Daily Extremities Joint Pain Intensity >3 on 0-10 a NPS

• Headache Exacerbation/attack 3 times per week with the average intensity >3 on a 0-10 NPS, lasting > 4 hours in the past three months

• Hamilton Rating Scale of Depression (HRSD) <14 based on the sum of scores for the first 17 items

Exclusion Criteria:

• Pregnancy

• History of pacemaker implant

• Any ferromagnetic (e.g. bullet fragment, shrapnel, device implant) in the brain or body that will prohibit the patients from having a brain MRI

• History of dementia, major psychiatric diseases, or life-threatening diseases

• Presence of any other chronic neuropathic pain states such as Complex Regional Pain Syndrome or Painful Peripheral Neuropathy

• History of seizure

• Pending litigation

• Low back pain with mechanical origins such as lumbar radiculopathy or radiculitis or lumbar facet arthropathy

• Lack of ability to understand the experimental protocol and to adequately communicate in English

• History of Traumatic Brain injury

• Chronic Tension or Cluster Headache

• Ongoing Cognitive Rehabilitation or Treatment of PTSD

Related Conditions & MeSH terms

• Arthralgia
• Gulf War Illness
• Gulf War Syndrome
• Headache
• Joint Pain
• Muscle Pain
• Myalgia
• Pain
• Persian Gulf Syndrome

Intervention

Device:
• Transcranial Magnetic Stimulation
A non-invasive treatment that emits magnetic pulses to stimulate the brain.
• Sham Transcranial Magnetic Stimulation
Sham rTMS will consist of the same parameters as active, however, the subject will not receive the actual magnetic stimulation due to the use of a double sided Active/Sham coil used specifically for research studies.

Locations

Country	Name	City	State
United States	VA Atlanta	Decatur	Georgia
United States	VA Palo Alto	Palo Alto	California
United States	VA San Diego Healthcare System	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Veterans Medical Research Foundation	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to post treatment of GWI-related pain and headaches	This outcome will be measured through daily self-reporting logs that tracks headache, muscle, and joint pain. A numerical rating scale of 0, being no pain, to 10, being worst possible pain, will be used to report pain and headaches.	Baseline, 1-week, 1-month, 2-month, and 3-month
Primary	Change from baseline to post treatment of sensory and affective aspects of pain	Short Form McGill Pain Questionnaire (SF-MPQ): This is a self-report questionnaire that allows individuals to describe the quality and intensity of pain they are experiencing. This will be used to assess the sensory and affective aspects of muscle and joint pain.	Baseline, 1-week, 1-month, 2-month, and 3-month
Primary	Change from baseline to post treatment of headaches	The Headache Impact Test (HIT-6) will be used to measure how headaches affect the individual's ability to function in different domains. This 6-question form assesses the severity of headache pain and is scored with a range of 36-78, with higher scores indicating a larger impact of headaches on functionality.	Baseline, 1-week, 1-month, 2-month, and 3-month
Primary	Change from baseline to post treatment of quality of life	The Short Form Health Survey-36 (SF-36) is a self-reported survey of patient health. It is a measure of health status and quality of life in regards to eight main areas: vitality, physical functioning, bodily pain, health perceptions, physical, emotional, and social role functioning and mental health.	Baseline, 1-week, 1-month, 2-month, and 3-month
Primary	Change from baseline to post treatment of body pain	A Brief Pain Inventory-Short Form (BPI-SF) questionnaire will also be used to assess the severity of pain and the impact of pain on daily functions. The BPI-SF consists of five questions. Four items measure pain on 11-point response scales from 0 to 10 ("No Pain" to "Pain as bad as you can imagine". Another item, containing 7 sub-questions, evaluates the level of pain interference with daily functioning on 11-point response scales from 0 to 10 ("Does not interfere" to "Completely interferes").	Baseline, 1-week, 1-month, 2-month, and 3-month
Primary	Change from baseline to post treatment of muscle pain	The New Clinical Fibromyalgia Diagnostic Criteria - Part 1 will be used to assess muscle pain. Patients will be asked to rate the average (over the past 24 hours) intensity of muscle pain for up to 12 locations of the body.	Baseline, 1-week, 1-month, 2-month, and 3-month
Primary	Change from baseline to post treatment of fibromyalgia	A Revised Fibromyalgia Impact Questionnaire will be used to evaluate the function, overall impact and symptoms of Fibromyalgia. There are a total of 21 questions, each with a range of 0-10, with 10 being either "very difficult" or "always."	Baseline, 1-week, 1-month, 2-month, and 3-month
Primary	Change from baseline to post treatment of neurobehavioral symptoms	Baseline, 1-week, 1-month, 2-month, and 3-month	The Neurobehavioral Symptoms Inventory (NSI) is a self-report questionnaire on the severity of various behavioral symptoms and is measured using a 5-item scale. It asks the subjects to indicate the extent to which each symptom has disturbed them.
Primary	Change from baseline to post treatment of sleep quality	The Pittsburgh Sleep Quality Index (PSQI) questionnaire has nineteen individual items which are used to generate seven composite scores on: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Questions are either free-response or have a range from 0-3, with 3 being "more frequent" or "very bad."	Baseline, 1-week, 1-month, 2-month, and 3-month
Primary	Change from baseline to post treatment of sleep difficulties	The Insomnia Severity Index measures the severity of an individual's sleep difficulties. All questions range from 0-4 and the sum of the answers would give the total score. The total score range from 0-28.	Baseline, 1-week, 1-month, 2-month, and 3-month
Primary	Change from baseline to post treatment of fatigue	The Flinders Fatigue Scale measures daytime fatigue associated with insomnia through a 7-item questionnaire. The questions range from 1-5, with 5 being "extremely" or "entirely."	Baseline, 1-week, 1-month, 2-month, and 3-month
Secondary	Change from baseline to post treatment of PTSD symptoms	The Clinician-Administered PTSD Scale (CAPS-5), 30-item structured interview that can be used to diagnose PTSD and associated symptoms, will be used to assess PTSD symptoms	Baseline, 1-week, 1-month, 2-month, and 3-month
Secondary	Change in opioid-based pain medication usage	Medication assessment consists of daily chronic and breakthrough opioid usage for pain or headache. Average daily dosage will be converted to equal-potent oral Morphine Sulfate dosage based on the clinical opioid conversion table used by the VA San Diego Healthcare System Pain Service and University of California, San Diego, Center for Pain Medicine. The study participants will be asked to remain on the same analgesic medication(s) during the study period but are allowed to titrate down their narcotic usage.	Baseline, 1-week, 1-month, 2-month, and 3-month
Secondary	Explore changes in supraspinal resting state functional connectivity	The outcome measure will be assessed through functional magnetic imaging scans and subsequent processing.	Baseline and 1-week post treatment