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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04182659
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Veterans Medical Research Foundation
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Albert Leung, M.D.
Principal Investigator Affiliation	San Diego Veterans Healthcare System
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, U.S. Fed
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Gulf War Syndrome, Gulf War Illness, Headache, Muscle Pain, Joint Pain

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Active rTMS at the LMC

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

Sham Comparator: Sham rTMS at the LMC

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

Interventions

Device: - Transcranial Magnetic Stimulation

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

Device: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

VA Palo Alto, Palo Alto, California

Status

Recruiting

Address

VA Palo Alto

Palo Alto, California, 94304

Site Contact

Valentino Basilio

[email protected]

650-514-6614

VA San Diego Healthcare System, San Diego, California

Status