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Improving Functions in MTBI Patients With Headache by rTMS

NCT01948947 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2018-03-26

Study results available
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Summary

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).

Conditions

  • TBI (Traumatic Brain Injury)

Interventions

DEVICE

Transcranial Magnetic Stimulation

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

DEVICE

Sham Transcranial Magnetic Stimulation

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

Sponsors & Collaborators

  • United States Naval Medical Center, San Diego

    collaborator FED

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Albert Y Leung, MD · VA San Diego Healthcare System, San Diego, CA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01948947 on ClinicalTrials.gov