NCT03030794

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

January 18, 2020

Status Verified

August 1, 2018

Enrollment Period

2.5 years

First QC Date

January 4, 2017

Last Update Submit

January 13, 2020

Conditions

Gulf War SyndromeHeadache

Keywords

Gulf War IllnessHeadacheMuscle PainJoint PainTMS

Outcome Measures

Primary Outcomes (5)

  • Daily Headache and Pain Log

    This is a daily self-reporting log that tracks headache, muscle pain, and joint pain levels. The pain levels are scored from 0-10 with 10 being the worst possible pain.

    2 months for each subject (11 visits)

  • Headache Impact Test 6 (HIT-6)

    This 6-question form assesses the severity of headache pain and is scored with a range of 36-78. The higher score, the higher the impact of headaches on functional ability.

    2 months for each subject (11 visits)

  • 2 months for each subject (11 visits)

    This assessment has 9 questions about pain level, relief, and interference. Pain level and interference questions range from 0-10, with 10 being the worst. Level of relief has a range of 0-100%, with 100% being complete relief.

    2 months for each subject (11 visits)

  • Opioid Medication Assessment

    This is a self-reporting log that tracks opioid medication usage. Average daily dosages are converted to equal-potent oral Morphine Sulfate dosage and reported in milligrams.

    2 months for each subject (11 visits)

  • Mechanical-Visual Analogue Scale

    This scale measures the level of headache, muscle, and joint pain at each visit. This ranges from 0-100, with 100 being the worst possible pain.

    2 months for each subject (11 visits)

Secondary Outcomes (13)

  • Neurobehavioral Symptom Inventory (NSI)

    2 months for each subject (11 visits)

  • Short-Form McGill Pain Questionnaire (SF-MPQ)

    2 months for each subject (11 visits)

  • New Clinical Fibromyalgia Diagnostic Criteria

    2 months for each subject (11 visits)

  • Revised Fibromyalgia Impact Questionnaire (FIQR)

    2 months for each subject (11 visits)

  • Conners Continuous Performance Test 2 (CPT2)

    2 months for each subject (11 visits)

  • +8 more secondary outcomes

Study Arms (2)

Repetitive TMS

ACTIVE COMPARATOR

Subjects will receive the repetitive transcranial magnetic stimulation study procedure.

Device: Repetitive transcranial magnetic stimulation

No (blocked) repetitive TMS

PLACEBO COMPARATOR

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.

Device: Repetitive transcranial magnetic stimulation (sham)

Interventions

Repetitive transcranial magnetic stimulationDEVICE

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

Repetitive TMS
Repetitive transcranial magnetic stimulation (sham)DEVICE

No brain stimulation will be administered.

No (blocked) repetitive TMS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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
  • Criteria for healthy veterans without Gulf War Illness headaches and pain:
  • Male or female between ages 18-65
  • Served at least 30 consecutive days in the Persian Gulf between 8/90-7/91
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Veteran Affairs Hospital

San Diego, California, 92161, United States

Location

Related Publications (3)

  • 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.

    PMID: 19464959BACKGROUND

  • 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.

    PMID: 26555886BACKGROUND

  • 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.

    PMID: 33116195DERIVED

MeSH Terms

Conditions

Persian Gulf SyndromeHeadacheMyalgiaArthralgia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Occupational DiseasesWar-Related InjuriesWounds and InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainJoint Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Albert Leung, M.D.

    VA San Diego Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2017

First Posted

January 25, 2017

Study Start

December 1, 2016

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

January 18, 2020

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)