RECRUITING

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

Conditions

Gulf War Syndrome Gulf War Illness Headache Muscle Pain Joint Pain rTMS Transcranial Magnetic Stimulation

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-10-01

Study Completion:2023-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04182659

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Caleb Lopez, BS

CONTACT

858-552-8585

caleb.lopez@va.gov

Principal Investigator

Albert Leung, M.D.

PRINCIPAL_INVESTIGATOR

San Diego Veterans Healthcare System

Study Locations (Sites)

VA Palo Alto

Palo Alto, California, 94304

United States

VA San Diego Healthcare System

San Diego, California, 92161

United States

VA Atlanta

Decatur, Georgia, 30033

United States

Collaborators and Investigators

Sponsor: Veterans Medical Research Foundation

Albert Leung, M.D., PRINCIPAL_INVESTIGATOR, San Diego Veterans Healthcare System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-10-01

Study Completion Date2023-09-30

Study Record Updates

Study Start Date2019-10-01

Study Completion Date2023-09-30

Terms related to this study

Keywords Provided by Researchers

rTMS
Transcranial Magnetic Stimulation
Gulf War Illness

Additional Relevant MeSH Terms

Gulf War Syndrome
Gulf War Illness
Headache
Muscle Pain
Joint Pain