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| ID | Type | Description | Link |
|---|---|---|---|
| H130281 SPiRE rTMS MTBI HA | Other Identifier | San Diego VA Healthcare System |
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| Name | Class |
|---|---|
| United States Naval Medical Center, San Diego | FED |
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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).
This study will only be conducted at the Veterans Affair hospital in San Diego.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Magnetic Stimulation | Experimental | Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device | Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Y Leung, MD | VA San Diego Healthcare System, San Diego, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33953315 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transcranial Magnetic Stimulation | Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex. Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex. |
| FG001 | Sham Transcranial Magnetic Stimulation | Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil. Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Transcranial Magnetic Stimulation | Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex. Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex. |
| BG001 | Sham Transcranial Magnetic Stimulation |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percent change from baseline | 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. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transcranial Magnetic Stimulation | Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex. Transcranial Magnetic Stimulation: Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Valerie Metzger Smith, Study Coordinator | VA San Diego Healthcare System | 858-750-0274 | valerie.metzgersmith@va.gov |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| Sham Transcranial Magnetic Stimulation | Device | Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil. |
|
| 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. |
Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil. Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Sham Transcranial Magnetic Stimulation | Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil. Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil. |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | percent change from baseline | 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. |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | percent change from baseline | 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. |
|
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|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percent change in score from baseline | 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. |
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Sham Transcranial Magnetic Stimulation | Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil. Sham Transcranial Magnetic Stimulation: Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil. | 0 | 15 | 0 | 15 | 0 | 15 |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
Change from Baseline to 1-Month post-treatment |
| Other |
| Other |