Improving Functions in MTBI Patients With Headache by rTMS

VA Office of Research and Development

Status: Completed

Conditions: TBI (Traumatic Brain Injury)

Treatments: Device: Sham Transcranial Magnetic Stimulation; Device: Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01948947

H130281 SPiRE rTMS MTBI HA (Other Identifier)

F1359-P

Details and patient eligibility

About

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).

Full description

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

Enrollment: 29 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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29 participants in 2 patient groups

Transcranial Magnetic Stimulation

Experimental group

Description:

Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.

Treatment:

Device: Transcranial Magnetic Stimulation

Sham Transcranial Magnetic Stimulation

Sham Comparator group

Description:

Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.

Treatment:

Device: Sham Transcranial Magnetic Stimulation