RecruitingNot ApplicableNCT05176392

Combined Transcranial Magnetic Stimulation and Therapy for MTBI Related Headaches

Combined Nonpharmacological Therapies for MTBI-Related Headaches


Sponsor

Veterans Medical Research Foundation

Enrollment

240 participants

Start Date

Jan 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study will assess the combined effectiveness of repetitive transcranial magnetic stimulation (rTMS) and telehealth based therapy in helping manage mild traumatic brain injury (mTBI) related headaches. The investigators hypothesize that active rTMS combined with telehealth therapy will provide marked reduction in mTBI related headaches and symptoms in comparison to their placebo counterparts.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

  • Mild Traumatic Brain Injury (mTBI)
  • Chronic headaches \> 3 months after injury
  • Aged 18-65
  • No prior TMS treatment
  • Persistent Headaches with an intensity \> 30 / 100
  • No history of daily headache prior to mTBI

Exclusion Criteria9

  • Pregnant
  • Pacemaker or any metal in body that would prevent MRI
  • History of dementia or major psychiatric disease, such as bipolar disorder or schizophrenia
  • Presence of any other chronic neuropathic pain states
  • History of seizure
  • Pending litigation
  • Can't understand English
  • History of chronic headache like migraine prior to mTBI
  • Evidence in chart of exacerbation of depressive/anxiety symptoms, active substance dependence, suicidal intent or attempt within previous month

Interventions

BEHAVIORALHeadache Education Control

In the control, educational sessions on headaches will be provided.

DEVICEActive rTMS

Active rTMS will be given at the left dorsolateral prefrontal cortex with a double blind TMS coil.

BEHAVIORALHeadache Management Therapy

Therapy will be provided on headache management.

DEVICESham rTMS

Sham rTMS will be given at the left dorsolateral prefrontal cortex. All parameters of the treatment will appear identical to the active treatment, with only the rTMS coil used to administer the treatment flipped 180 degrees to prevent stimulation.


Locations(1)

VA San Diego Healthcare System

San Diego, California, United States

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NCT05176392


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