TBI (Traumatic Brain Injury)NCT01948947
Improving Functions in MTBI Patients With Headache by rTMS
A study testing Transcranial Magnetic Stimulation in people with TBI (Traumatic Brain Injury), run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- TBI (Traumatic Brain Injury)
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Sep 2016
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
About this study
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).
Read the detailed description
This study will only be conducted at the Veterans Affair hospital in San Diego.
- Conditions
- TBI (Traumatic Brain Injury)
- Being tested
- Transcranial Magnetic Stimulation, Sham Transcranial Magnetic Stimulation
- Medical subject headings
- Brain Injuries, Traumatic
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 dorsal lateral prefrontal cortex.
Sham Transcranial Magnetic StimulationDevice
Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Magnetic Stimulation | Experimental | Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex. Receives: Device: Transcranial Magnetic Stimulation |
| Sham Transcranial Magnetic Stimulation | Sham comparator | Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil. Receives: Device: Sham Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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 assessed how their headaches interfered with their mood through the Hamilton Rating Scale for Depression assessment at baseline, 1-week follow-up and 1-month follow-up. The outcome was measured by adding the score of each question on the assessment and then comparing the averaged scores at the different time points. The larger the depression score, the more severe the depression. A larger percent change in depression score indicates a change in the severity of the depression.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startMay 2014
- Primary completionSep 2016
- Study completionSep 2016
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 TBI (Traumatic Brain Injury)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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- United States Naval Medical Center, San Diego
- Responsible party
- Sponsor
- Investigators
- Albert Y Leung, MD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948947
- Sponsor's protocol ID
- F1359-P
- Other IDs
- H130281 SPiRE rTMS MTBI HA
- Status last verified
- Feb 2018
- First submitted
- 17 Sep 2013
- Last updated
- 26 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33953315
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Functions in MTBI Patients With Headache by rTMS
- ClinicalTrials.gov ID
- NCT01948947
- Acronym / sponsor ID
- F1359-P
- Conditions
- TBI (Traumatic Brain Injury)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- United States Naval Medical Center, San Diego
- Study start
- May 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 24 Sep 2013 (estimated)
- Results
- Posted 26 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Magnetic Stimulation | Experimental | Device: Transcranial Magnetic StimulationActive-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex. |
| Sham Transcranial Magnetic Stimulation | Sham comparator | Device: Sham Transcranial Magnetic StimulationSham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
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 dorsal lateral prefrontal cortex. | Device | Transcranial Magnetic Stimulation |
| Sham Transcranial Magnetic StimulationSham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil. | Device | Sham Transcranial Magnetic Stimulation |
Primary outcome
Percent Change in Composite Score of Debilitating Headache (Intensity x Duration x Frequency)
Time frame: 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.
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.
Percent Change in Persistent Headache Intensity
Time frame: 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.
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.
Percent Change in Persistent Headache Prevalence
Time frame: 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.
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.
1 secondary outcome
Percent Change in Depression Score From Baseline to 1-Week Post-treatment
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33953315Vaninetti 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.
- 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 Y 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?
A study testing Transcranial Magnetic Stimulation in people with TBI (Traumatic Brain Injury), run by VA Office of Research and Development at 1 site in United States.
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 7 inclusion and 9 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 26 Mar 2018. 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 26 Mar 2018). 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?
Percent Change in Composite Score of Debilitating Headache (Intensity x Duration x Frequency) (time frame: 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.). The study lists 3 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 NCT01948947, 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 26 Mar 2018.