Traumatic Brain Injury (TBI)NCT03314584

Managing Mild Traumatic Brain Injury Related Headaches With Repetitive Transcranial Magnetic Stimulation

A study testing Transcranial Magnetic Stimulation and Magnetic resonance imaging (MRI) in people with Traumatic Brain Injury (TBI), run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Traumatic Brain Injury (TBI)
What is being tested?: Transcranial Magnetic Stimulation and Magnetic resonance imaging (MRI)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 179 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2018to 31 Jan 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 24Show fewer

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

Who cannot join

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

Show all 14Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002

Other trials in United States

About this study

Official title: Long Term Efficacy of rTMS in Managing MTBI-related Headache

Read the detailed description

Headache is one of the most common debilitating chronic pain conditions in either active or retired military personnel with MTBI. This high prevalence of persistent chronic headache is often associated with neuropsychological dysfunction in mood, attention, and memory, which casts a profound negative impact on patients' quality of life and increases stress in their caregivers. Unfortunately, as witnessed by the investigators in their clinical practices, conventional pharmacological treatments for MTBI related headache (MTBI-HA) has not been shown to be effective and drugs such as narcotics contain many long-term untoward psychosomatic and abusive side effects. This calls for an urgent need in developing alternate and innovative long-term headache management strategies for this rapidly increasing patient population.

Coinciding with other published treatment protocols related to traumatic brain injury and pain, this initial clinical evidence provides compelling support for the current proposal aiming to assess the effect of a longer duration of rTMS protocol in managing MTBI-HA for up to 10 weeks after the initiation of the treatment. Given existing treatment options for MTBI-HA are limited, validating such a non-pharmacological and non-invasive treatment option will significantly enhance the capability of the VA healthcare system in caring for this rapidly increasing patient population.

PRE-TREATMENT PHASE (weeks 1-2) consists of Visit 1 (Screening Visit) and Visit 2 (Pre-treatment Assessments);
TREAMENT PHASE (week 3-4) consists of Visits 3-12 (Neuronavigation guided rTMS consisting of 10 weekday treatments at >24 and < 72 hours apart, weekends excluded, maximum 5 weeks for treatment completion) rTMS will take place in Building 23 Room 105 at the VASDHS; and
POST-TREATMENT PHASE (week 5-14) consists of two initial weekly visits (Visits 13\&14) and two additional biweekly visits (Visits 15\&16) and one monthly visit (Visit 17).

Brain anatomical and functional MRI will be performed within 72 hours after Visits 2 and 13. Subjects will be required to fill out headache diary between assessment visits. Headache assessments along with quality of life, mood and functions assessments will be carried out at Visits 1,2, and 13--17. This frequency of treatment and duration of follow-up is in line with recently published rTMS articles related to TBI, headache and pain, and also in accordance with the 3-month post treatment initiation follow-up guideline/recommendation.

Conditions: Traumatic Brain Injury (TBI)
Being tested: Transcranial Magnetic Stimulation, Sham Transcranial Magnetic Stimulation, Magnetic resonance imaging (MRI)
Keywords: TBI, traumatic brain injury, transcranial magnetic stimulation, headache
Medical subject headings: Brain Injuries, Traumatic, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial Magnetic StimulationDevice
Active-repetitive transcranial magnetic stimulation (rTMS) at the left motor cortex.
Sham Transcranial Magnetic StimulationDevice
Sham rTMS will consist of the same parameters as active, however, the subject will not receive the actual magnetic stimulation to the left motor cortex due to the use of a double sided Active/Sham coil used specifically for research studies.
Magnetic resonance imaging (MRI)Diagnostic test
Brain imaging will be done via MRI prior to the first rTMS/Sham TMS session. Imaging will allow investigators to target specific areas in the brain.

Study groups in NCT03314584
Study group	Role	What they receive
Transcranial Magnetic Stimulation	Experimental	Active-repetitive transcranial magnetic stimulation (rTMS) at the left motor cortex. Receives: Device: Transcranial Magnetic Stimulation; Diagnostic Test: Magnetic resonance imaging (MRI)
Sham Transcranial Magnetic Stimulation	Sham comparator	Sham rTMS will consist of the same parameters as active, however, the subject will not receive the actual magnetic stimulation to the left motor cortex. Receives: Device: Sham Transcranial Magnetic Stimulation; Diagnostic Test: Magnetic resonance imaging (MRI)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Headache Days Per Week
The outcome measure will be quantified through the headache diary log that tracks the intensity, frequency and duration of MTBI-headaches (MTBI-HA). Baseline data includes all logs from the start of the study until the start of treatment. Post-intervention data looked at the time between the 3-month follow-up and the previous visit.
Measured: The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).
Number of Days With Debilitating MTBI-headaches Per Week.
The outcome measure will be quantified through the headache diary log that tracks the intensity, frequency and duration of MTBI-headaches (MTBI-HA). Baseline data includes all logs from the start of the study until the start of treatment. Post-intervention data looked at the time between the 3-month follow-up and the previous visit.
Measured: The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).
Duration of Debilitating MTBI-headaches (Hours).
The outcome measure will be quantified through the headache diary log that tracks the intensity, frequency and duration of MTBI-headaches (MTBI-HA). Baseline data includes all logs from the start of the study until the start of treatment. Post-intervention data looked at the time between the 3-month follow-up and the previous visit.
Measured: The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatments occurred for 2-5 weeks starting in week 3).
Average Interference (0-10) of Headaches in Daily Activities.
The outcome measure will be quantified through the headache diary log that tracks the intensity, frequency, duration, and interference of MTBI-headaches (MTBI-HA). A score of 0 for interference would indicate no interference in daily activities while a score of 10 would indicate complete interference (e.g. the subject could not get out of bed and go to work due to their pain). Baseline data includes all logs from the start of the study until the start of treatment. Post-intervention data looked at the time between the 3-month follow-up and the previous visit.
Measured: The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).
Baseline vs Post-Treatment HIT-6 Scores (36-78).
The outcome measure is measuring headache impact on quality of life and will be quantified through the self-assessed Headache Impact Test (HIT-6). Each question ranges from 6-13 and the total score ranges from 36 to 78. The assessment indicates the effect that headaches have on normal daily life and ability to function with a higher score indicating more interference in daily life and function.
Measured: The measure will be assessed every visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).
Change From Baseline to Post-Treatment HDRS-17 Scores
The outcome measure will be measuring depression scores and will be quantified through the administered Hamilton Scale for Depression. This contains 17 items to be rated (HDRS-17), but four other questions are not added to the total score and are used to provide additional clinical information. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item, and the total score is compared to the corresponding descriptor. The total score ranges from 0 to 53 and is calculated from adding together the first 17 questions. A higher score indicated more severe depression.
Measured: The measure will be assessed each visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).
Connors Continuous Performance Test Score.
The outcome measure quantified through the Connors continuous performance test will be sustained and selective attention. This is administered on a laptop and is automatically scored. Key performance indicators are reported as T-scores (mean of 50, SD = 10) and percentiles. T-scores are compared to the normative sample. Variability measure which looked at response speed consistency and indicated fluctuations in attention. A higher score indicated more fluctuations.
Measured: The measure will be assessed every visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).
Brief Pain Inventory Global Score.
The outcome will measure global pain through the brief pain inventory assessment. Pain will be recorded at it's worst, it's best and on average over the previous 24 hours on a 0 to 10 scale These scores are reflected in questions 3-6 of the assessment and will be averaged together to give an overall average pain level score with a higher value reflecting more pain. Then the pain's impact on general activity, mood, walking ability, normal work, relationships, sleep and enjoyment of life will be measured on a 0 to 10 scale and averaged for an overall pain score. These scores are reflected in question 9a-g and will be averaged together to give an overall average pain interference level with a higher value indicating more interference in daily life.
Measured: The measure will be assessed every visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).
Hopkins Verbal Learning Test (HVLT-R) Total Scores
The Hopkins Verbal Learning Test (HVLT-R) will be used to measure memory. In this assessment, 12 words are taught and subjects are tasked to recall those words in three difference trials. When scoring the HVLT-R, the number of words recalled are summed to calculate a total recall score which ranges from 0-36 with higher values indicating more words being recalled.
Measured: The measure will be assessed every visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).
Stroop Test Score
The Stroop test was administered to assess cognitive functioning performance. In the test, the participant must demonstrate inhibition of cognitive interference by naming the color of the colored word instead of the word itself based on the observation that normal individuals can read words much faster than they can identify and name colors. This follows two other trials where the participant just reads the words aloud and another trial of the participant just identifying the color of a series of x's. Each trial, the participant was given 45 second to identify as many colors as they could. There is no maximum score for this assessment. This assessment is scored by the number of items they were able to correctly read out rather than on a T-score. A higher score indicated higher cognitive functioning.
Measured: The measure will be assessed every visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).
Average Intensity of Persistent Headaches.
The outcome measure will be quantified through the headache diary log that tracks the intensity, frequency and duration of MTBI-headaches (MTBI-HA). Intensity was rated on a scale of 0-10 with 0 indicating no pain and 10 indicating the worst pain they have experienced. Baseline data includes all logs from the start of the study until the start of treatment. Post-intervention data looked at the time between the 3-month follow-up and the previous visit.
Measured: The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).
Average Intensity of Debilitating Headaches.
The outcome measure will be quantified through the headache diary log that tracks the intensity, frequency and duration of MTBI-headaches (MTBI-HA). Intensity was rated on a scale of 0-10 with 0 indicating no pain and 10 indicating the worst pain they have experience. Baseline data includes all logs from the start of the study until the start of treatment. Post-intervention data looked at the time between the 3-month follow-up and the previous visit.
Measured: The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).

Secondary outcomes (1)

Significant T-Values for Connectivity Between Regions.
Resting state functional magnetic imaging scans and subsequent processing using CONN Toolbox were used to determine T-values. ROIs (region of interest) where determined and compared to other ROIs to assess connectivity between regions. Value of "0" indicated no significant connectivity between regions (p<0.01). The sign of the value indicated directionality of connectivity. Larger absolute values of the T-value indicated stronger connectivity.
Measured: Subjects will have 2 functional magnetic imaging scans, at baseline and then at the 1-week post treatment follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201831 Jan 2024

First posted19 Oct 2017
Study start1 Jan 2018
Primary completion30 Sep 2023
Study completion31 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Traumatic Brain Injury (TBI)Studies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 179 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03314584
Sponsor's protocol ID: B2506-I
Other IDs: H170053
Status last verified: Jul 2025
First submitted: 4 Oct 2017
Last updated: 7 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Leung A, Ho M, Vaninetti M, Krug P, Rutledge T, Lin L, Tsai A, Le L, Rimmele C, Lee R, Golshan S. Long-term Efficacy of Repetitive Transcranial Magnetic Stimulation at Motor Cortex for Mild Traumatic Brain Injury-Related Headaches. Neuromodulation. 2026 Feb;29(2):326-338. doi: 10.1016/j.neurom.2025.09.308. Epub 2025 Oct 19.
PubMed 41109991

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long Term Efficacy of rTMS in Managing MTBI-related Headache
ClinicalTrials.gov ID: NCT03314584
Acronym / sponsor ID: B2506-I
Conditions: Traumatic Brain Injury (TBI)
Keywords: TBI, traumatic brain injury, transcranial magnetic stimulation, headache
Study type: Interventional
Recruitment status: Completed
Enrolment: 179 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 1 Jan 2018 (actual)
Primary completion: 30 Sep 2023 (actual)
Study completion: 31 Jan 2024 (actual)
First posted: 19 Oct 2017 (actual)
Results: Posted 7 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRE-TREATMENT PHASE (weeks 1-2) consists of Visit 1 (Screening Visit) and Visit 2 (Pre-treatment Assessments);
TREAMENT PHASE (week 3-4) consists of Visits 3-12 (Neuronavigation guided rTMS consisting of 10 weekday treatments at >24 and < 72 hours apart, weekends excluded, maximum 5 weeks for treatment completion) rTMS will take place in Building 23 Room 105 at the VASDHS; and
POST-TREATMENT PHASE (week 5-14) consists of two initial weekly visits (Visits 13\&14) and two additional biweekly visits (Visits 15\&16) and one monthly visit (Visit 17).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Transcranial Magnetic Stimulation	Experimental	Device: Transcranial Magnetic Stimulation, Diagnostic Test: Magnetic resonance imaging (MRI)Active-repetitive transcranial magnetic stimulation (rTMS) at the left motor cortex.
Sham Transcranial Magnetic Stimulation	Sham comparator	Device: Sham Transcranial Magnetic Stimulation, Diagnostic Test: Magnetic resonance imaging (MRI)Sham rTMS will consist of the same parameters as active, however, the subject will not receive the actual magnetic stimulation to the left motor cortex.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (24 listed)

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.:
Focal neurologic deficit (s) that may or may not be transient but where the severity of the injury does not exceed the following:

Key exclusion criteria (14 listed)

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.:
history of dementia, major psychiatric or life threatening diseases
presence of any other chronic neuropathic pain states;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcranial Magnetic StimulationActive-repetitive transcranial magnetic stimulation (rTMS) at the left motor cortex.	Device	Transcranial Magnetic Stimulation
Sham Transcranial Magnetic StimulationSham rTMS will consist of the same parameters as active, however, the subject will not receive the actual magnetic stimulation to the left motor cortex due to the use of a double sided Active/Sham coil used specifically for research studies.	Device	Sham Transcranial Magnetic Stimulation
Magnetic resonance imaging (MRI)Brain imaging will be done via MRI prior to the first rTMS/Sham TMS session. Imaging will allow investigators to target specific areas in the brain.	Diagnostic test	Sham Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation

Primary outcome

Number of Headache Days Per Week
Time frame: The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).
The outcome measure will be quantified through the headache diary log that tracks the intensity, frequency and duration of MTBI-headaches (MTBI-HA). Baseline data includes all logs from the start of the study until the start of treatment. Post-intervention data looked at the time between the 3-month follow-up and the previous visit.
Number of Days With Debilitating MTBI-headaches Per Week.
Time frame: The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).
The outcome measure will be quantified through the headache diary log that tracks the intensity, frequency and duration of MTBI-headaches (MTBI-HA). Baseline data includes all logs from the start of the study until the start of treatment. Post-intervention data looked at the time between the 3-month follow-up and the previous visit.
Duration of Debilitating MTBI-headaches (Hours).
Time frame: The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatments occurred for 2-5 weeks starting in week 3).
The outcome measure will be quantified through the headache diary log that tracks the intensity, frequency and duration of MTBI-headaches (MTBI-HA). Baseline data includes all logs from the start of the study until the start of treatment. Post-intervention data looked at the time between the 3-month follow-up and the previous visit.
Average Interference (0-10) of Headaches in Daily Activities.
Time frame: The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).
The outcome measure will be quantified through the headache diary log that tracks the intensity, frequency, duration, and interference of MTBI-headaches (MTBI-HA). A score of 0 for interference would indicate no interference in daily activities while a score of 10 would indicate complete interference (e.g. the subject could not get out of bed and go to work due to their pain). Baseline data includes all logs from the start of the study until the start of treatment. Post-intervention data looked at the time between the 3-month follow-up and the previous visit.
Baseline vs Post-Treatment HIT-6 Scores (36-78).
Time frame: The measure will be assessed every visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).
The outcome measure is measuring headache impact on quality of life and will be quantified through the self-assessed Headache Impact Test (HIT-6). Each question ranges from 6-13 and the total score ranges from 36 to 78. The assessment indicates the effect that headaches have on normal daily life and ability to function with a higher score indicating more interference in daily life and function.
Change From Baseline to Post-Treatment HDRS-17 Scores
Time frame: The measure will be assessed each visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).
The outcome measure will be measuring depression scores and will be quantified through the administered Hamilton Scale for Depression. This contains 17 items to be rated (HDRS-17), but four other questions are not added to the total score and are used to provide additional clinical information. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item, and the total score is compared to the corresponding descriptor. The total score ranges from 0 to 53 and is calculated from adding together the first 17 questions. A higher score indicated more severe depression.
Connors Continuous Performance Test Score.
Time frame: The measure will be assessed every visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).
The outcome measure quantified through the Connors continuous performance test will be sustained and selective attention. This is administered on a laptop and is automatically scored. Key performance indicators are reported as T-scores (mean of 50, SD = 10) and percentiles. T-scores are compared to the normative sample. Variability measure which looked at response speed consistency and indicated fluctuations in attention. A higher score indicated more fluctuations.
Brief Pain Inventory Global Score.
Time frame: The measure will be assessed every visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).
The outcome will measure global pain through the brief pain inventory assessment. Pain will be recorded at it's worst, it's best and on average over the previous 24 hours on a 0 to 10 scale These scores are reflected in questions 3-6 of the assessment and will be averaged together to give an overall average pain level score with a higher value reflecting more pain. Then the pain's impact on general activity, mood, walking ability, normal work, relationships, sleep and enjoyment of life will be measured on a 0 to 10 scale and averaged for an overall pain score. These scores are reflected in question 9a-g and will be averaged together to give an overall average pain interference level with a higher value indicating more interference in daily life.
Hopkins Verbal Learning Test (HVLT-R) Total Scores
Time frame: The measure will be assessed every visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).
The Hopkins Verbal Learning Test (HVLT-R) will be used to measure memory. In this assessment, 12 words are taught and subjects are tasked to recall those words in three difference trials. When scoring the HVLT-R, the number of words recalled are summed to calculate a total recall score which ranges from 0-36 with higher values indicating more words being recalled.
Stroop Test Score
Time frame: The measure will be assessed every visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).
The Stroop test was administered to assess cognitive functioning performance. In the test, the participant must demonstrate inhibition of cognitive interference by naming the color of the colored word instead of the word itself based on the observation that normal individuals can read words much faster than they can identify and name colors. This follows two other trials where the participant just reads the words aloud and another trial of the participant just identifying the color of a series of x's. Each trial, the participant was given 45 second to identify as many colors as they could. There is no maximum score for this assessment. This assessment is scored by the number of items they were able to correctly read out rather than on a T-score. A higher score indicated higher cognitive functioning.
Average Intensity of Persistent Headaches.
Time frame: The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).
The outcome measure will be quantified through the headache diary log that tracks the intensity, frequency and duration of MTBI-headaches (MTBI-HA). Intensity was rated on a scale of 0-10 with 0 indicating no pain and 10 indicating the worst pain they have experienced. Baseline data includes all logs from the start of the study until the start of treatment. Post-intervention data looked at the time between the 3-month follow-up and the previous visit.
Average Intensity of Debilitating Headaches.
Time frame: The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).
The outcome measure will be quantified through the headache diary log that tracks the intensity, frequency and duration of MTBI-headaches (MTBI-HA). Intensity was rated on a scale of 0-10 with 0 indicating no pain and 10 indicating the worst pain they have experience. Baseline data includes all logs from the start of the study until the start of treatment. Post-intervention data looked at the time between the 3-month follow-up and the previous visit.

1 secondary outcome

Significant T-Values for Connectivity Between Regions.
Time frame: Subjects will have 2 functional magnetic imaging scans, at baseline and then at the 1-week post treatment follow-up.

Results and safety

Results posted to the registry on 7 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Transcranial Magnetic Stimulation	38	31
Sham Transcranial Magnetic Stimulation	41	38

Primary outcome: Number of Headache Days Per Week

Time frame: The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).. Mean (Standard Deviation). Unit: days/week

Measure	Transcranial Magnetic Stimulation n = 32	Sham Transcranial Magnetic Stimulation n = 38
Pre-intervention persistent headache frequency	4.2 (2.9)	4.6 (2.0)
Post-intervention (3-months after TX) persistent headache frequency	3.1 (2.3)	4.3 (1.9)

Transcranial Magnetic Stimulation vs Sham Transcranial Magnetic Stimulation: p <0.000, Mixed Models Analysis

Population analysed: Some subjects are missing their 3-month follow up data due to it not being collected.

Primary outcome: Number of Days With Debilitating MTBI-headaches Per Week.

Time frame: The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).. Mean (Standard Deviation). Unit: days/week

Measure	Transcranial Magnetic Stimulation n = 30	Sham Transcranial Magnetic Stimulation n = 38
Pre-intervention debilitating headache frequency	2.1 (2.0)	2.1 (1.9)
Post-intervention (3-months after TX) debilitating headache frequency	1.3 (1.8)	1.8 (1.7)

Transcranial Magnetic Stimulation vs Sham Transcranial Magnetic Stimulation: p = 0.004, Mixed Models Analysis

Population analysed: Some subjects were excluded from the pre-intervention or post-intervention data due to missing data. Subjects did not need both to be included in the analysis. The number analyzed below reflects that total subjects with valid data for that group and time point.

Primary outcome: Duration of Debilitating MTBI-headaches (Hours).

Time frame: The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatments occurred for 2-5 weeks starting in week 3).. Mean (Standard Deviation). Unit: hours

Measure	Transcranial Magnetic Stimulation n = 30	Sham Transcranial Magnetic Stimulation n = 38
Pre-intervention debilitating headache duration	3.5 (1.6)	5.5 (4.6)
Post-intervention (3-months after TX) debilitating headache duration	4.3 (3.3)	5.0 (4.3)

Transcranial Magnetic Stimulation vs Sham Transcranial Magnetic Stimulation: p = 0.046, Mixed Models Analysis

Primary outcome: Average Interference (0-10) of Headaches in Daily Activities.

Time frame: The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).. Mean (Standard Deviation). Unit: score on a scale

Measure	Transcranial Magnetic Stimulation n = 30	Sham Transcranial Magnetic Stimulation n = 38
Pre-intervention debilitating headache interference	6.9 (1.5)	6.6 (1.8)
Post-intervention (3-months after TX) debilitating headache interference	5.8 (2.1)	5.7 (2.6)

Transcranial Magnetic Stimulation vs Sham Transcranial Magnetic Stimulation: p = 0.018, Mixed Models Analysis

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Transcranial Magnetic Stimulation	1 of 38 (2.6%)	0 of 38 (0%)	0 of 38
Sham Transcranial Magnetic Stimulation	2 of 41 (4.9%)	0 of 41 (0%)	0 of 41

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41109991Leung A, Ho M, Vaninetti M, Krug P, Rutledge T, Lin L, Tsai A, Le L, Rimmele C, Lee R, Golshan S. Long-term Efficacy of Repetitive Transcranial Magnetic Stimulation at Motor Cortex for Mild Traumatic Brain Injury-Related Headaches. Neuromodulation. 2026 Feb;29(2):326-338. doi: 10.1016/j.neurom.2025.09.308. Epub 2025 Oct 19.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Albert Yick Leung, MD principal investigator

VA San Diego Healthcare System, San Diego, CA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Headache Days Per Week (time frame: The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3).). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03314584, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.