Improving Functions in MTBI Patients With Headache by rTMS

Completed · Not applicable · Has a placebo group

Conditions studied: TBI (Traumatic Brain Injury)

In brief

Due to recent wars in Afghanistan and Iraq, the number of Veteran suffering from Mild traumatic brain(MTBI) injury and PTSD increases rapidly. Headache is one of the most debilitating clinical symptoms in Veteran with MTBI and the cause of it is still not entirely clear. Recently, the use of non-invasive brain stimulation such as repetitive transcranial magnetic stimulation(rTMS) has yielded favorable clinical outcome in a few intractable chronic central pain conditions including headaches. This study aims to 1) assess the effect of rTMS in relieving headache and improving neurophysiological functions; and 2)explore the neuronal mechanisms associated with MTBI related headache and the analgesic effect of rTMS with function magnetic resonance imaging (fMRI).

Key facts

Study ID

NCT01948947

Run by

VA Office of Research and Development

People needed

29

Starts

2014-05-01

Expected to finish

2016-09-01

Last updated by the study team

2018-03-26

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Pregnancy
• History of pacemaker implant
• 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 dementia, major psychiatric diseases, 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 prior to the incidence of MTBI

Where it is running

• VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States

Full record on ClinicalTrials.gov

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