The effect of intermittent theta burst repetitive transcranial magnetic stimulation in the treatment of chronic migraine: A double-blind sham-controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- reduction in migraine days, frequency, severity, and duration in migraine in chronic migraine patient
研究概览
简要总结
Title: Effect of intermittent theta burst repetitive transcranial magnetic stimulation in treatment of chronic migraine: A double-blind sham-controlled Introduction
Migraine is characterized by episodes of headaches, usually unilateral pulsating, associated with photophobia, phonophobia, nausea and/or vomiting, typically lasting 4-72 hours. There is growing evidence of the effective use of transcranial magnetic stimulation using stimulation over the left prefrontal cortex. Recent evidence suggests the effective use of theta burst protocol on the left prefrontal cortex, reducing the severity and frequency of migraine episodes. We aim to explore the effectiveness of a theta burst protocol in managing migraines in our institute using a randomized, sham-controlled design.
Aim and objectives: to assess the efficacy of adjunctive prophylactic use of intermittent theta-burst stimulation (iTBS) on left DLPFC in a patient with Chronic migraine.
Methodology: The participants undergo observation and assessment for two weeks to determine their migraine pattern. Following this, the intervention started using the protocol:
a. Stimulus intensity: 80% of Resting Motor threshold (RMT), Frequency-50 Hz, Burst frequency-5Hz.
b. A total of 1000 pulses are delivered in 20 cycles.
c. Number of sessions: 5 sessions in 5 days.
d. Patient assessed for any rTMS-related side effects (i.e., rTMS induced Headache)
the patient is assessed for severity, intensity, and duration of migraine by MIDAS, Headache Impact Test-6 (HIT-6), Pain Numbering Rating Scale (NPRS) and migraine dairy in the 4th, 6th, and 12th week of the post-intervention period.
Participants recruited by purposive sampling A total of 60 participants (30 in each group) were randomized by block randomization, resulting in active and sham-controlled groups. The active arm received true stimulation, while the controlled arm received only sham protocol.
Participants are to be assessed with the help of the Hamilton Depression Rating Scale (HAMD), Migraine Disability Scale (MIDAS), Numeric Pain Rating Scale (NPRS), and Headache Impact Test-6.
We hypothesised that the theta burst stimulation of the left dorsolateral prefrontal cortex effectively reduces migraine episodes in terms of severity, frequency and duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with migraine, diagnosed according to the International Classification of Headache Disorders (ICHD-3rd edition) 2.Age between 18-60 years 3.Sex: all gender 4.Written informed consent for the study obtained from the participants.
- •5.With or without any prophylactic treatment.
排除标准
- •1.Any other type of chronic or recurrent headache such as diagnosed as sinusitis, refractive errors, cervical spondylosis, and neurological conditions.
- •2.Neuropsychiatry disorders Organic brain conditions, History of severe head injury, epilepsy, space occupying lesion, trigeminal neuralgia, hydrocephalous, meningitis, and other pain conditions.
- •3.Otherwise physically healthy conditions 4.Psychogenic pain, tension headache, Somatoform pain disorder 5.Use of botulinum toxin in head or neck region in last 6 months.
- •6.Active phase of any major Psychiatry illness (Schizophrenia, Bipolar disorder), substance use disorder (except moderate tea and nicotine use).
- •7.Active phase of depression 8.Confirmed Pregnancy • Having cochlear implant, cardiac pacemaker and metal body implanted in the body.
结局指标
主要结局
reduction in migraine days, frequency, severity, and duration in migraine in chronic migraine patient
时间窗: patient is assessed for severity, intensity, and duration of migraine by MIDAS, Headache Impact Test-6 (HIT-6)and migraine dairy at 4th, 6th, and 12th week of post-intervention period
次要结局
- To compare the improvement from the bassline in intensity of migraine attacks and burden of drugs used for the episode of migraine in the active rTMS and sham rTMS group.(4th,6th and 12th week of post intervention period)
研究者
Dr Sujita Singh
AIIMS, Raipur