Improving Functions in MTBI Patients With Headache by rTMS
2018년 2월 23일 업데이트: VA Office of Research and Development
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).
연구 개요
상태
완전한
정황
상세 설명
This study will only be conducted at the Veterans Affair hospital in San Diego.
연구 유형
중재적
등록 (실제)
29
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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San Diego, California, 미국, 92161
- VA San Diego Healthcare System, San Diego, CA
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Transcranial Magnetic Stimulation
Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.
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Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.
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가짜 비교기: 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.
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percent Change in Composite Score of Debilitating Headache (Intensity x Duration x Frequency)
기간: 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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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.
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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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Percent Change in Persistent Headache Intensity
기간: 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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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.
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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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Percent Change in Persistent Headache Prevalence
기간: 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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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.
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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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percent Change in Depression Score From Baseline to 1-Week Post-treatment
기간: 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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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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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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Albert Y Leung, MD, VA San Diego Healthcare System, San Diego, CA
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2014년 5월 1일
기본 완료 (실제)
2016년 9월 1일
연구 완료 (실제)
2016년 9월 1일
연구 등록 날짜
최초 제출
2013년 9월 17일
QC 기준을 충족하는 최초 제출
2013년 9월 19일
처음 게시됨 (추정)
2013년 9월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 3월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 2월 23일
마지막으로 확인됨
2018년 2월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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