Managing MTBI-related Headaches With rTMS

Inclusion Criteria:

- 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:

- A. Any headache fulfilling criteria C and D

- B. Traumatic injury to the head has occurred

- C. Headache is reported to have developed within 7 d after one of the following:

- 1. injury to the head

- 2. regaining of consciousness following the injury

- 3. discontinuation of medication(s) that impairs the ability to sense or report
headache following the injury

- D. Headache persists for >3 mo after injury to the head

- E. 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

Exclusion Criteria:

- 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