N/A
N=79
Managing Mild Traumatic Brain Injury Related Headaches With Repetitive Transcranial Magnetic Stimulation
Traumatic Brain Injury (TBI)
Bottom Line
View on ClinicalTrials.gov: NCT03314584 ↗Enrolled (actual)
79
Serious AEs
3.8%
Results posted
Aug 2025
Primary outcome: Primary: Number of Headache Days Per Week — 4.2; 4.6; 3.1; 4.3 days/week — p=<0.000
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Magnetic Stimulation (Device); Sham Transcranial Magnetic Stimulation (Device); Magnetic resonance imaging (MRI) (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Headache Days Per Week |
4.2; 4.6; 3.1; 4.3 | <0.000 sig |
| PRIMARY Number of Days With Debilitating MTBI-headaches Per Week. |
2.1; 2.1; 1.3; 1.8 | 0.004 sig |
| PRIMARY Duration of Debilitating MTBI-headaches (Hours). |
3.5; 5.5; 4.3; 5.0 | 0.046 sig |
| PRIMARY Average Interference (0-10) of Headaches in Daily Activities. |
6.9; 6.6; 5.8; 5.7 | 0.018 sig |
| PRIMARY Baseline vs Post-Treatment HIT-6 Scores (36-78). |
65.2; 65.1; 60.7; 60.3 | 0.598 |
| PRIMARY Change From Baseline to Post-Treatment HDRS-17 Scores |
14.5; 16.5; 11.8; 12.3 | 0.296 |
| PRIMARY Connors Continuous Performance Test Score. |
58.0; 66.1; 61.3; 56.1 | 0.033 sig |
| PRIMARY Brief Pain Inventory Global Score. |
5.1; 5.5; 4.2; 4.3 | 0.606 |
| PRIMARY Hopkins Verbal Learning Test (HVLT-R) Total Scores |
23.5; 21.9; 24.2; 23.7 | 0.287 |
| PRIMARY Stroop Test Score |
36.6; 37.2; 44.2; 43.6 | 0.049 sig |
| PRIMARY Average Intensity of Persistent Headaches. |
5.0; 4.7; 3.8; 3.9 | 0.338 |
| PRIMARY Average Intensity of Debilitating Headaches. |
6.6; 6.5; 5.8; 5.7 | — |
| SECONDARY Significant T-Values for Connectivity Between Regions. |
4.06; 6.12; 8.77; 8.76; -3.23; -3.61 | — |
Summary
Persistent headache is one of the most common debilitating symptoms in military personnel suffering from mild traumatic brain injury (MTBI). This study aims to assess the long-term effect of repetitive transcranial magnetic stimulation (rTMS) in managing MTBI related headaches for up to 2-3 months by comparing the treatment effect of active-rTMS to sham-rTMS.
Eligibility Criteria
Inclusion Criteria
- The following diagnostic criteria for MTBI based on the 1993 American Congress of Rehabilitation Medicine and recent recommendation from the DOD, and the current diagnostic criteria adopted by the VASDHS TBI Clinic will be used for the study. A traumatically induced physiological disruption of brain function, as manifested by at least one of the following:
- any loss of consciousness
- any loss of memory for events immediately before or after the accident
- any alteration in mental state at the time of the accident, e.g.:
- feeling dazed
- disoriented
- confused)
- Focal neurologic deficit (s) that may or may not be transient but where the severity of the injury does not exceed the following:
- loss of consciousness of approximately 30 min or less
- after 30 min, an initial Glasgow Coma Scale score of 13-15
- post-traumatic amnesia not greater than 24 hrs
- In addition, the following established diagnostic criteria for " Persistent headache attributed to mild traumatic injury headache" based on the International Classification of Headache Disorder (ICHD-3) will be applied to the study subjects:
- A. Any headache fulfilling criteria C and D
- B. Traumatic injury to the head has occurred
- C. Headache is reported to have developed within 7 d after one of the following:
- 1. injury to the head
- 2. regaining of consciousness following the injury
- 3. discontinuation of medication(s) that impairs the ability to sense or report headache following the injury
- D. Headache persists for >3 mo after injury to the head
- E. Not better accounted for by another ICHD-3 diagnosis
Additional Inclusion Criteria:
- no prior experience of TMS treatment
- average persistent headache intensity more than 30 on the 0-100 mechanical visual analog scale(M-VAS) at the screening visit (visit 1) and average persistent headache intensity score greater than 3/10 on a numerical rating scale (NRS) reported in the headache diary (between visits 1&2)
- no history of daily persistent headache prior to the MTBI incidence
Exclusion Criteria
- pregnancy; To be eligible for the study and to ensure no pregnancy risk, you will need to utilize contraception or practice abstinence until your study participation is completed
- history of pacemaker implant
- any ferromagnetic material in the brain or body that would prohibit the patients from having a brain MRI, e.g.:
- bullet fragment
- shrapnel
- device implant
- history of dementia, major psychiatric 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 diagnoses such migraine, tension or cluster headaches prior to the incidence of MTBI.
- history of chronic headache prior to the MTBI incidence at a frequency more than once a month lasting more than one hour.
- evidence in the chart of recent exacerbation of depressive or anxiety symptoms, active substance dependence, suicidal intent or attempt within the previous month, and/or current psychotic symptoms
Data sourced from ClinicalTrials.gov (NCT03314584). 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.