Improving Functions in MTBI Patients With Headache by rTMS
2 other identifiers
interventional
29
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2013
CompletedFirst Posted
Study publicly available on registry
September 24, 2013
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
March 26, 2018
CompletedMarch 26, 2018
February 1, 2018
2.3 years
September 17, 2013
October 24, 2017
February 23, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Percent Change in Composite Score of Debilitating Headache (Intensity x Duration x Frequency)
The primary outcome time-point measurement will be averaged from each day the subject is enrolled in the study for each of the 3 time point periods: pre-treatment baseline, 1-week follow-up and 1-month follow-up. The results depict change in the composite score: intensity (scale of 0-10) x duration (# of hours) x frequency (# headaches per week). The larger composite score for each subject, the worse the debilitating headaches.
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.
Percent Change in Persistent Headache Intensity
The persistent headache measure was assessed through a daily headache log over the course of the subjects participation in the study and averaged for the time point period of baseline, 1-week and 1-month results. The persistent headache is based on a scale of 0-10, the higher the persistent headache intensity averaged score the worse the persistent headache.
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.
Percent Change in Persistent Headache Prevalence
The persistent headache prevalence measure was assessed through a daily headache log over the course of the subjects participation in the study and collected at baseline, 1-week and 1-month. The persistent headache is defined as having had 3+ continuous headaches over the course of the time point periods and was coded as either yes or no. The results indicate the percent change in the prevalence of persistent headaches for the subjects at the time points. A larger reduction percent indicates a larger decrease in subjects with those persistent headaches.
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 (1)
Percent Change in Depression Score From Baseline to 1-Week Post-treatment
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.
Study Arms (2)
Transcranial Magnetic Stimulation
EXPERIMENTALActive-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.
Sham Transcranial Magnetic Stimulation
SHAM COMPARATORSham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
Interventions
Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.
Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161, United States
Related Publications (1)
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.
PMID: 33953315DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Valerie Metzger Smith, Study Coordinator
- Organization
- VA San Diego Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Albert Y Leung, MD
VA San Diego Healthcare System, San Diego, CA
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2013
First Posted
September 24, 2013
Study Start
May 1, 2014
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
March 26, 2018
Results First Posted
March 26, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share