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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Ashish Duggal, DM (Neurology)
- 電話番号：+919810523332
- メール：ashishduggal2005@gmail.com
研究連絡先のバックアップ
- 名前：Ketan Bhatnagar, Pursuing DM Neurology
- 電話番号：+917062874305
- メール：Ketanbhatnagar2024@gmail.com
研究場所
-
-
-
New Delhi、インド、110001
- Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital
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コンタクト：
- Ashish Duggal, DM (Neurology)
- 電話番号：+919810523332
- メール：ashishduggal2005@gmail.com
-
コンタクト：
- Ketan Bhatnagar, Pursuing DM Neurology
- 電話番号：+917062874305
- メール：Ketanbhatnagar2024@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Anodal TDCS Arm (will receive true tDCS)
Will receive true Anodal tDCS
|
Patients in group A will receive true anodal stimulation
Patients in group B will receive Sham stimulation
|
|
偽コンパレータ：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in frequency of moderate-severe headache days (week 12 vs baseline).
時間枠：12 weeks
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in migraine days (week 12 vs baseline).
時間枠：12 weeks
|
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
時間枠：12 weeks
|
The number of patients having a 50% reduction in migraine days per month in both groups was calculated at week 12
|
12 weeks
|
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Change in headache severity (week 12 vs baseline).
時間枠：12 weeks
|
The change in headache severity will be assessed at week 12 from baseline in terms of visual analogue score (0-3)
|
12 weeks
|
|
Change in number of days with acute medication use (week 12 vs baseline)
時間枠：12 weeks
|
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.
|
12 weeks
|
|
Change in PHQ-9 scores (week 12 vs baseline)
時間枠：12 weeks
|
Change in Patient Health Questionnaire-9 (PHQ-9) scores from baseline to Week 12
|
12 weeks
|
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Change in MIDAS score (week 12 vs baseline)
時間枠：12 weeks
|
Change in Migraine Disability Assessment (MIDAS) scores from baseline to Week 12, assessing changes in migraine-related disability.
|
12 weeks
|
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Change in HIT - 6 scores (week 12 vs baseline)
時間枠：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.
|
12 weeks
|
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Change in Migraine specific Quality of Life (week 12 vs baseline)
時間枠：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.
|
12 weeks
|
|
Safety Outcome - Adverse events reported by the patients after each session of tDCS
時間枠：12 weeks
|
Incidence and severity of adverse events reported by participants following each transcranial direct current stimulation (tDCS) session, monitored throughout the study period.
|
12 weeks
|
協力者と研究者
捜査官
- 主任研究者：Ashish K Duggal, DM Neurology、ABVIMS and Dr RML Hospital, New Delhi
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IEC/ABVIMS/RMLH/394
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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