Recruitment

Recruitment Status
Completed
Estimated Enrollment
56

Inclusion Criterias

Male or female age between 18 to 50
No prior experience of TMS treatment
History of headache more than 3 months
...
Male or female age between 18 to 50
No prior experience of TMS treatment
History of headache more than 3 months
History of MTBI based on the clinical diagnostic criteria
At least one headache exacerbation per day
A normal brain MRI in the past 3 months
Pre-treatment headache intensity M-VAS 30(0-100 scale) and average daily headache NPS 3(0-10 scale)

Exclusion Criterias

History of seizure
Lack of ability to understand the experimental protocol and to adequately communicate in English
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 seizure
Lack of ability to understand the experimental protocol and to adequately communicate in English
Any ferromagnetic(e.g. bullet fragment, shrapnel, device implant) in the brain or body that will prohibit the patients from having a brain MRI
Pending litigation
History of pacemaker implant
History of chronic headache prior to the incidence of MTBI
Presence of any other chronic neuropathic pain states
Pregnancy
History of dementia, major psychiatric diseases, or life threatening diseases

Summary

Conditions
TBI (Traumatic Brain Injury)
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 50 years
Gender
Both males and females

Description

This study will only be conducted at the Veterans Affair hospital in San Diego.

This study will only be conducted at the Veterans Affair hospital in San Diego.

Inclusion Criterias

Male or female age between 18 to 50
No prior experience of TMS treatment
History of headache more than 3 months
...
Male or female age between 18 to 50
No prior experience of TMS treatment
History of headache more than 3 months
History of MTBI based on the clinical diagnostic criteria
At least one headache exacerbation per day
A normal brain MRI in the past 3 months
Pre-treatment headache intensity M-VAS 30(0-100 scale) and average daily headache NPS 3(0-10 scale)

Exclusion Criterias

History of seizure
Lack of ability to understand the experimental protocol and to adequately communicate in English
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 seizure
Lack of ability to understand the experimental protocol and to adequately communicate in English
Any ferromagnetic(e.g. bullet fragment, shrapnel, device implant) in the brain or body that will prohibit the patients from having a brain MRI
Pending litigation
History of pacemaker implant
History of chronic headache prior to the incidence of MTBI
Presence of any other chronic neuropathic pain states
Pregnancy
History of dementia, major psychiatric diseases, or life threatening diseases

Locations

San Diego, California, 92161
San Diego, California, 92161

Tracking Information

NCT #
NCT01948947
Collaborators
United States Naval Medical Center, San Diego
Investigators
  • Principal Investigator: Albert Y Leung, MD VA San Diego Healthcare System, San Diego, CA
  • Albert Y Leung, MD VA San Diego Healthcare System, San Diego, CA