N/A
N=29
Improving Functions in MTBI Patients With Headache by rTMS
TBI (Traumatic Brain Injury)
Bottom Line
View on ClinicalTrials.gov: NCT01948947 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Percent Change in Composite Score of Debilitating Headache (Intensity x Duration x Frequency) — -55.3; -1.7; -58.4; -10 percent change from baseline — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Magnetic Stimulation (Device); Sham Transcranial Magnetic Stimulation (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Composite Score of Debilitating Headache (Intensity x Duration x Frequency) |
-55.3; -1.7; -58.4; -10 | <0.0001 sig |
| PRIMARY Percent Change in Persistent Headache Intensity |
-25.3; -1.0; -22.6; -2.3 | <0.001 sig |
| PRIMARY Percent Change in Persistent Headache Prevalence |
-50; -7; -57; -20 | 0.009 sig |
| SECONDARY Percent Change in Depression Score From Baseline to 1-Week Post-treatment |
-14.8; -2.7 | =0.033 sig |
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).
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
Data sourced from ClinicalTrials.gov (NCT01948947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.