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

NCT04182659 | Unknown DMC FDA Device

• 1 other identifier: H190071
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Gulf War Syndrome; Gulf War Illness; Headache; Muscle Pain; Joint Pain

Keywords

rTMS; Transcranial Magnetic Stimulation; Gulf War Illness

Outcome Measures

Primary Outcomes (11)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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.

• 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

• 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

• 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 Outcomes (3)

• Change from baseline to post treatment of PTSD symptoms

  Baseline, 1-week, 1-month, 2-month, and 3-month

• Change in opioid-based pain medication usage

  Baseline, 1-week, 1-month, 2-month, and 3-month

• Explore changes in supraspinal resting state functional connectivity

  Baseline and 1-week post treatment

Study Arms (2)

Active rTMS at the LMC

ACTIVE COMPARATOR

Subjects will receive the repetitive Transcranial Magnetic Stimulation (rTMS) study procedure at the left motor cortex (LMC)

Device: Transcranial Magnetic Stimulation

Sham rTMS at the LMC

SHAM COMPARATOR

Sham rTMS will appear the same as the active, with the same parameters, but will not receive the actual magnetic stimulation to the LMC.

Device: Sham Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

A non-invasive treatment that emits magnetic pulses to stimulate the brain.

Active rTMS at the LMC

Sham Transcranial Magnetic Stimulation DEVICE

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.

Sham rTMS at the LMC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Veterans Medical Research Foundation: lead
• United States Department of Defense: collaborator

Study Sites (3)

VA Palo Alto

Palo Alto, California, 94304, United States

RECRUITING

VA San Diego Healthcare System

San Diego, California, 92161, United States

RECRUITING

VA Atlanta

Decatur, Georgia, 30033, United States

RECRUITING

MeSH Terms

Conditions

Persian Gulf Syndrome; Headache; Myalgia; Arthralgia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Occupational Diseases; War-Related Injuries; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Joint Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Albert Leung, M.D.

  San Diego Veterans Healthcare System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caleb Lopez, BS

CONTACT

858-552-8585; caleb.lopez@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a double-blinded study where only the statistician is aware of the randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There are two groups: one will receive active rTMS and the other group will receive sham rTMS.

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 2, 2019
• Study Start: October 1, 2019
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)