Clinical trial NCT01948947: Improving Functions in MTBI Patients With Headache by rTMS
Official title: Improving Functions in MTBI Patients With Headache by rTMS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TBI (Traumatic Brain Injury)
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: United States Naval Medical Center, San Diego
First posted: 2013-09-24
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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

Eligibility criteria: 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

Primary outcomes:
measure: Percent Change in Composite Score of Debilitating Headache (Intensity x Duration x Frequency)
timeFrame: Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured and averaged.
measure: Percent Change in Persistent Headache Intensity
timeFrame: Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured and averaged.
measure: Percent Change in Persistent Headache Prevalence
timeFrame: Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured.
Secondary outcomes:
measure: Percent Change in Depression Score From Baseline to 1-Week Post-treatment
timeFrame: Subjects will have a total of 9 visits over the span of 3 months and 3 of those visits will qualify as a time point at which outcome is measured.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Albert Y Leung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vaninetti M, Lim M, Khalaf A, Metzger-Smith V, Flowers M, Kunnel A, Yang E, Song D, Lin L, Tsai A, Lee R, Golshan S, Leung A. fMRI findings in MTBI patients with headaches following rTMS. Sci Rep. 2021 May 5;11(1):9573. doi: 10.1038/s41598-021-89118-2.