Summary

for people ages 18-50 (full criteria)
at San Diego, California
study started
estimated completion:
Albert Yick Leung

Description

Summary

Persistent headache is one of the most common debilitating symptoms in military personnel suffering from mild traumatic brain injury (MTBI). This study aims to assess the long-term effect of repetitive transcranial magnetic stimulation (rTMS) in managing MTBI related headaches for up to 2-3 months by comparing the treatment effect of active-rTMS to sham-rTMS.

Official Title

Long Term Efficacy of rTMS in Managing MTBI-related Headache

Keywords

Traumatic Brain Injury (TBI) TBI traumatic brain injury transcranial magnetic stimulation headache Brain Injuries Brain Injuries, Traumatic Sham Transcranial Magnetic Stimulation

Eligibility

You can join if…

Open to people ages 18-50

  • The following diagnostic criteria for MTBI based on the 1993 American Congress of Rehabilitation Medicine and recent recommendation from the DOD, and the current diagnostic criteria adopted by the VASDHS TBI Clinic will be used for the study. A traumatically induced physiological disruption of brain function, as manifested by at least one of the following:
  • any loss of consciousness
  • any loss of memory for events immediately before or after the accident
  • any alteration in mental state at the time of the accident, e.g.:
  • feeling dazed
  • disoriented
  • confused)
  • Focal neurologic deficit (s) that may or may not be transient but where the severity of the injury does not exceed the following:
  • loss of consciousness of approximately 30 min or less
  • after 30 min, an initial Glasgow Coma Scale score of 13-15
  • post-traumatic amnesia not greater than 24 hrs
  • In addition, the following established diagnostic criteria for " Persistent headache attributed to mild traumatic injury headache" based on the International

Classification of Headache Disorder (ICHD-3) will be applied to the study subjects:

    1. Any headache fulfilling criteria C and D
    1. Traumatic injury to the head has occurred
    1. Headache is reported to have developed within 7 d after one of the following:
    1. injury to the head
    1. regaining of consciousness following the injury
    1. discontinuation of medication(s) that impairs the ability to sense or report headache following the injury
    1. Headache persists for >3 mo after injury to the head
    1. Not better accounted for by another ICHD-3 diagnosis

Additional Inclusion Criteria:

  • no prior experience of TMS treatment
  • average persistent headache intensity more than 30 on the 0-100 mechanical visual analog scale(M-VAS) at the screening visit (visit 1)[64] and average persistent headache intensity score greater than 3/10 on a numerical rating scale (NRS) reported in the headache diary (between visits 1&2)
  • no history of daily persistent headache prior to the MTBI incidence

You CAN'T join if...

  • pregnancy; To be eligible for the study and to ensure no pregnancy risk, you will need to utilize contraception or practice abstinence until your study participation is completed
  • history of pacemaker implant
  • any ferromagnetic material in the brain or body that would prohibit the patients from having a brain MRI, e.g.:
  • bullet fragment
  • shrapnel
  • device implant
  • history of dementia, major psychiatric or life threatening diseases
  • presence of any other chronic neuropathic pain states;
  • history of seizure
  • pending litigation
  • lack of ability to understand the experimental protocol and to adequately communicate in English
  • history of chronic headache diagnoses such migraine, tension or cluster headaches prior to the incidence of MTBI.
  • history of chronic headache prior to the MTBI incidence at a frequency more than once a month lasting more than one hour.
  • evidence in the chart of recent exacerbation of depressive or anxiety symptoms, active substance dependence, suicidal intent or attempt within the previous month, and/or current psychotic symptoms

Location

  • VA San Diego Healthcare System, San Diego, CA accepting new patients
    San Diego California 92161 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
ID
NCT03314584
Lead Scientist
Albert Yick Leung
Study Type
Interventional
Last Updated
June 19, 2018