Alleviating Headache and Pain in GWI With Neuronavigation Guided rTMS

NCT ID: NCT03030794

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2019-06-30

Brief Summary

This study aims to assess the effect of repetitive transcranial magnetic stimulation (rTMS) on Gulf War illness related headaches and pain.

Detailed Description

Headaches (HA) and wide spread pain are some of the most common debilitating symptoms in Gulf War Veterans (GWV) with Gulf War Illness (GWI). Migraine like HA and diffuse body pain were detected in 64% of GWV with GWI. This high prevalence of chronic HA and diffuse body pain conditions are often associated with neuropsychological dysfunction in mood, attention, memory and other systemic symptoms, which cast a profound negative impact on patients' quality of life. Unfortunately, conventional pharmacological treatments for GWI related headaches and pain (GWI-HAP) has not been shown to be effective and drugs such as narcotics contain many long term untoward psychosomatic and abusive side effects. Therefore, developing and validating non-invasive and low risk innovative treatment for this patient population is warranted. Transcranial Magnetic Stimulation (TMS) is currently a US FDA approved treatment for major depression and migraine HA.

Conditions

Gulf War Syndrome; Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Repetitive TMS

Subjects will receive the repetitive transcranial magnetic stimulation study procedure.

Group Type: ACTIVE_COMPARATOR

Repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

A non-invasive method of brain stimulation that emits a magnetic pulse.

No (blocked) repetitive TMS

Subjects will not receive the repetitive transcranial magnetic stimulation study procedure by blocking the stimulation between the coil and the head, but the audiovisual conditions will be mimicked.

Group Type: PLACEBO_COMPARATOR

Repetitive transcranial magnetic stimulation (sham)

Intervention Type: DEVICE

No brain stimulation will be administered.

Interventions

Repetitive transcranial magnetic stimulation

A non-invasive method of brain stimulation that emits a magnetic pulse.

Intervention Type: DEVICE

Repetitive transcranial magnetic stimulation (sham)

No brain stimulation will be administered.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or female between ages 18-65
• CDC Criteria for GWI
• Kansas Criteria for GWI
• International Headache Society Criteria for Migraine HA w/o aura
• Average Headache Exacerbation Intensity >3 on 0-10 NPRS
• Average Overall Daily Muscle Pain Intensity >3 on 0-10 NPRS
• Average Overall Daily Extremities Joint Pain Intensity >3 on 0-10 NPRS
• Headache Exacerbation/Attack ≥ 3 times/week, lasting >4 hrs in past 3 months

• Male or female between ages 18-65
• Served at least 30 consecutive days in the Persian Gulf between 8/90-7/91

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

Criteria for healthy veterans without Gulf War Illness headaches and pain:

• CDC Criteria for GWI
• Kansas Criteria for GWI
• International Headache Society Criteria for Migraine HA w/o aura
• Average Headache Exacerbation Intensity >3 on 0-10 NPRS
• Average Overall Daily Muscle Pain Intensity >3 on 0-10 NPRS
• Average Overall Daily Extremities Joint Pain Intensity >3 on 0-10 NPRS
• Headache Exacerbation/Attack ≥ 3 times/week, lasting >4 hrs in past 3 months
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Veterans Medical Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Albert Leung, M.D.

Role: PRINCIPAL_INVESTIGATOR

VA San Diego Health Care System

Locations

Naval Medical Center San Diego

San Diego, California, United States

Veteran Affairs Hospital

San Diego, California, United States

Countries

United States

References

Leung A, Donohue M, Xu R, Lee R, Lefaucheur JP, Khedr EM, Saitoh Y, Andre-Obadia N, Rollnik J, Wallace M, Chen R. rTMS for suppressing neuropathic pain: a meta-analysis. J Pain. 2009 Dec;10(12):1205-16. doi: 10.1016/j.jpain.2009.03.010. Epub 2009 May 23.

Reference Type: BACKGROUND

PMID: 19464959 (View on PubMed)

Leung A, Shukla S, Fallah A, Song D, Lin L, Golshan S, Tsai A, Jak A, Polston G, Lee R. Repetitive Transcranial Magnetic Stimulation in Managing Mild Traumatic Brain Injury-Related Headaches. Neuromodulation. 2016 Feb;19(2):133-41. doi: 10.1111/ner.12364. Epub 2015 Nov 10.

Reference Type: BACKGROUND

PMID: 26555886 (View on PubMed)

Lei K, Kunnel A, Metzger-Smith V, Golshan S, Javors J, Wei J, Lee R, Vaninetti M, Rutledge T, Leung A. Diminished corticomotor excitability in Gulf War Illness related chronic pain symptoms; evidence from TMS study. Sci Rep. 2020 Oct 28;10(1):18520. doi: 10.1038/s41598-020-75006-8.

Reference Type: DERIVED

PMID: 33116195 (View on PubMed)

Other Identifiers

H160047

Identifier Type: -

Identifier Source: org_study_id