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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ashish Duggal, DM (Neurology)
- Número de teléfono: +919810523332
- Correo electrónico: ashishduggal2005@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Ketan Bhatnagar, Pursuing DM Neurology
- Número de teléfono: +917062874305
- Correo electrónico: Ketanbhatnagar2024@gmail.com
Ubicaciones de estudio
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New Delhi, India, 110001
- Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital
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Contacto:
- Ashish Duggal, DM (Neurology)
- Número de teléfono: +919810523332
- Correo electrónico: ashishduggal2005@gmail.com
-
Contacto:
- Ketan Bhatnagar, Pursuing DM Neurology
- Número de teléfono: +917062874305
- Correo electrónico: Ketanbhatnagar2024@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Comparador falso: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in frequency of moderate-severe headache days (week 12 vs baseline).
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in migraine days (week 12 vs baseline).
Periodo de tiempo: 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
Periodo de tiempo: 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).
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ashish K Duggal, DM Neurology, ABVIMS and Dr RML Hospital, New Delhi
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Trastornos de dolor de cabeza
- Dolor de cabeza
- Terapéutica
- Disciplinas y actividades de comportamiento
- Terapia de estimulación eléctrica
- Terapia convulsiva
- Terapias somáticas psiquiátricas
- Electrochoque
- Técnicas psicológicas
- Estimulación de corriente continua transcraneal
Otros números de identificación del estudio
- IEC/ABVIMS/RMLH/394
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
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