Managing MTBI-related Headaches With rTMS
Managing MTBI-related Headaches With rTMS
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.
Headache is one of the most common debilitating chronic pain conditions in either active or
 retired military personnel with MTBI. This high prevalence of persistent chronic headache is
 often associated with neuropsychological dysfunction in mood, attention, and memory, which
 casts a profound negative impact on patients' quality of life and increases stress in their
 caregivers. Unfortunately, as witnessed by the investigators in their clinical practices,
 conventional pharmacological treatments for MTBI related headache (MTBI-HA) has not been
 shown to be effective and drugs such as narcotics contain many long-term untoward
 psychosomatic and abusive side effects. This calls for an urgent need in developing alternate
 and innovative long-term headache management strategies for this rapidly increasing patient
 population.

 Coinciding with other published treatment protocols related to traumatic brain injury and
 pain, this initial clinical evidence provides compelling support for the current proposal
 aiming to assess the effect of a longer duration of rTMS protocol in managing MTBI-HA for up
 to 10 weeks after the initiation of the treatment. Given existing treatment options for
 MTBI-HA are limited, validating such a non-pharmacological and non-invasive treatment option
 will significantly enhance the capability of the VA healthcare system in caring for this
 rapidly increasing patient population.

 1. PRE-TREATMENT PHASE (weeks 1-2) consists of Visit 1 (Screening Visit) and Visit 2
 (Pre-treatment Assessments);

 2. TREAMENT PHASE (week 3-4) consists of Visits 3-12 (Neuronagvigation guided rTMS
 consisting of 10 weekday treatments at >24 and < 72 hours apart, weekends excluded,
 maximum 5 weeks for treatment completion) rTMS will take place in Building 23 Room 105
 at the VASDHS; and

 3. POST-TREATMENT PHASE (week 5-14) consists of two initial weekly visits (Visits 13&14)
 and two additional biweekly visits (Visits 15&16) and one monthly visit (Visit 17).

 Brain anatomical and functional MRI will be performed within 72 hours after Visits 2 and 13.
 Subjects will be required to fill out headache diary between assessment visits. Headache
 assessments along with quality of life, mood and functions assessments will be carried out at
 Visits 1,2, and 13--17. This frequency of treatment and duration of follow-up is in line with
 recently published rTMS articles related to TBI, headache and pain, and also in accordance
 with the 3-month post treatment initiation follow-up guideline/recommendation [32; 55; 80].
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) 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