EFFECT OF ANODAL TRANSCRANIAL DIRECT CURRENT STIMULATION (tDCS) OF PRIMARY MOTOR CORTEX ON HEADACHE FREQUENCY IN PATIENTS WITH CHRONIC MIGRAINE
Migraine is a common, heterogeneous neurological disorder affecting approximately 10-15% of the global population and is the third most prevalent disease worldwide. A wide range of pharmacological agents is available for migraine prophylaxis, with treatment selection generally guided by the patient's clinical profile, associated comorbidities, and individual tolerability. However, the effectiveness of preventive medications is often limited by adverse effects, leading to poor treatment adherence and discontinuation. Consequently, non-pharmacological interventions, particularly neuromodulation techniques, have gained increasing attention as potential therapeutic options for chronic migraine.
Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique that has demonstrated efficacy in modulating refractory pain in patients with chronic migraine, fibromyalgia, spinal cord injury, and trigeminal neuralgia. In addition, it has shown therapeutic benefits in several neurological and psychiatric disorders, including depression, stroke, epilepsy, and Parkinson's disease. The present study aims to evaluate the efficacy of anodal tDCS applied over the primary motor cortex as an adjunctive therapy for reducing headache frequency in patients with chronic migraine.
A total of 32 participants with chronic migraine will be enrolled and randomized using block randomization with a block size of four, stratified according to the presence or absence of medication-overuse headache (MOH), through an online randomization generator. Participants will be allocated to receive either active or sham tDCS. Before randomization, all eligible patients will maintain a baseline headache diary for four weeks while continuing their existing prophylactic medications. Thereafter, they will undergo three 20-minute stimulation sessions administered during weeks 1, 5, and 9. Treatment outcomes will be evaluated at weeks 5, 9, and 12 using headache diary records and predefined objective assessment tools.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 3단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Ashish Duggal, DM (Neurology)
- 전화번호: +919810523332
- 이메일: ashishduggal2005@gmail.com
연구 연락처 백업
- 이름: Ketan Bhatnagar, Pursuing DM Neurology
- 전화번호: +917062874305
- 이메일: Ketanbhatnagar2024@gmail.com
연구 장소
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New Delhi, 인도, 110001
- Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital
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연락하다:
- Ashish Duggal, DM (Neurology)
- 전화번호: +919810523332
- 이메일: ashishduggal2005@gmail.com
-
연락하다:
- Ketan Bhatnagar, Pursuing DM Neurology
- 전화번호: +917062874305
- 이메일: Ketanbhatnagar2024@gmail.com
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients aged 18-60 years diagnosed with chronic migraine as per ICHD-3.
- Patients who were on a minimum of one concomitant preventive medication for not less than three months duration and a dose that was stable for at least one month prior to randomization.
- Willingness to provide informed consent and maintain a headache diary.
Exclusion Criteria:
- Patients with neurologic diseases such as tumours, seizures, dementia, meningitis, stroke, etc.
- Patients with barbiturate/opioid overuse or complications due to NSAID overuse.
- Patients failing to complete headache diary for more than 6 non-consecutive days during baseline.
- Illiterate patients without a caregiver to maintain the diary.
- Patients with pacemakers, cochlear implants.
- Pregnant women.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Anodal TDCS Arm (will receive true tDCS)
Will receive true Anodal tDCS
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Patients in group A will receive true anodal stimulation
Patients in group B will receive Sham stimulation
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가짜 비교기: Sham tDCS Arm (will receive sham stimulation)
Will receive sham tDCS stimulation
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Patients in group A will receive true anodal stimulation
Patients in group B will receive Sham stimulation
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in frequency of moderate-severe headache days (week 12 vs baseline).
기간: 12 weeks
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Change in the number of monthly moderate-to-severe headache days from baseline to Week 12, as recorded in the participant headache diary.
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12 weeks
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in migraine days (week 12 vs baseline).
기간: 12 weeks
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Change in the frequency of monthly migraine days from baseline to Week 12, as recorded in the participant headache diary.
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12 weeks
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50% responder rate
기간: 12 weeks
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The number of patients having a 50% reduction in migraine days per month in both groups was calculated at week 12
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12 weeks
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Change in headache severity (week 12 vs baseline).
기간: 12 weeks
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The change in headache severity will be assessed at week 12 from baseline in terms of visual analogue score (0-3)
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12 weeks
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Change in number of days with acute medication use (week 12 vs baseline)
기간: 12 weeks
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Change in the number of days requiring acute migraine medication use per month from baseline to Week 12, as recorded in the participant headache diary.
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12 weeks
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Change in PHQ-9 scores (week 12 vs baseline)
기간: 12 weeks
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Change in Patient Health Questionnaire-9 (PHQ-9) scores from baseline to Week 12
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12 weeks
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Change in MIDAS score (week 12 vs baseline)
기간: 12 weeks
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Change in Migraine Disability Assessment (MIDAS) scores from baseline to Week 12, assessing changes in migraine-related disability.
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12 weeks
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Change in HIT - 6 scores (week 12 vs baseline)
기간: 12 weeks
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Change in Headache Impact Test-6 (HIT-6) scores from baseline to Week 12, assessing the impact of headache on daily functioning and health-related quality of life.
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12 weeks
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Change in Migraine specific Quality of Life (week 12 vs baseline)
기간: 12 weeks
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Change in Migraine-Specific Quality of Life (MSQ) scores from baseline to Week 12, assessing changes in migraine-related quality of life.
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12 weeks
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Safety Outcome - Adverse events reported by the patients after each session of tDCS
기간: 12 weeks
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Incidence and severity of adverse events reported by participants following each transcranial direct current stimulation (tDCS) session, monitored throughout the study period.
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12 weeks
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Ashish K Duggal, DM Neurology, ABVIMS and Dr RML Hospital, New Delhi
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- IEC/ABVIMS/RMLH/394
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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