To study the efficacy and impact on quality of life of repetitive transcranial magnetic stimulation in chronic migraine patients- A Randomised Open labelled study
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- To look for severity of headache reduction between both the groups
Study Overview
Brief Summary
Headache is among one of the most common reasons to seek medical care at hospital. It may be debilitating to affect the quality of life and hamper the daily routine activities. Migraine is one of the primary headache disorders . In the Global Burden of Disease Study2010 (GBD2010), it was ranked as the third most prevalent disorder in the world. In GBD2015, it was ranked third–highest cause of disability worldwide in both males and females under the age of 50 years. Migraine that occurs on more than 15 days per month for 3 or more consecutive months is considered chronic migraine. Non invasive neuromodulation techniques are emerging as alternative or as adjunctive treatment in resistant headache disorders. Repetitive transcranial magnetic stimulation(rTMS) suppresses the cortical spreading depression that is pathognomic of headache. Variables to be considered in the application of rTMS are frequency of the pulse, coil geometry and position, rise time, depth penetration and safe stimulator design. It affects the levels of neurotransmitters, regulate synaptic plasticity and changes the neuronal networks that are implicated in the pain pathway.This study is designed to assess the efficacy of rTMS in the management of chronic migraine.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 15.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with migraine without aura with duration of symptoms for more than 15 days in a month for 3 months; non-responsive to medical treatment and willing to give consent will be included in the study.
Exclusion Criteria
- •Patients with headache secondary to Chronic tension-type and medication overuse Patients with abnormal computed tomography (CT) or magnetic resonance imaging (MRI) of the brain or with abnormal conventional EEG Patients with depression as determined by Hamilton Depression scale Patients with secondary causes of Headache Pregnant females Patients with epilepsy or family history of epilepsy Patients with a pacemaker, intracranial metal objects, and artificial metal tooth will be excluded also from the study.
Outcomes
Primary Outcomes
To look for severity of headache reduction between both the groups
Time Frame: 1 and 3 months
Secondary Outcomes
- To look for improvement in quality of life after treatment between both the groups(3 and 6 months)
Investigators
Pranjali Batra
Banaras Hindu University