Efficacy of Adjunctive Cerebellar Theta Transcranial Alternating Current Stimulation in Negative Symptoms of Schizophrenia: A Randomized Sham Controlled Proton Magnetic Resonance Spectroscopy (H1-MRS) Based Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cerebellar theta tACS results in a change in the negative symptoms at the end of 10 sessions.
研究概览
简要总结
Schizophrenia is a complex, chronic mental health disorder characterized by an array of symptoms, including delusions, hallucinations, disorganized speech or behavior, and impaired cognitive ability. Negative symptoms continue to remain as one of the greater causes of morbidity in patients with schizophrenia leaving the patient non-functional and thereby increasing the caregiver burden further. The pharmacological managements have proven to be of little use in managing the negative symptoms manifesting the need for other interventions. Transcranial alternating current stimulation (tACS) uses bidirectional biphasic current that periodically fluctuates/alternate from positive to negative charges across the 2 electrodes. It is hypothesized that if sinusoidal current is applied externally, it can increase or decrease the power of endogenous oscillatory rhythms in the brain and can potentially rectify the abnormalities in brain oscillations. A study has shown that stimulation of cerebellum using theta tACS has resulted in the changes in theta activity in frontal cortex. Thus this technique can thus be used to bring about activation in frontal cortex which can probably help in alleviating the negative symptoms.
Magnetic Resonance Spectroscopy can be used to measure the levels of various neuronal metabolites which can increase or decrease based on brain pathology. In neurodegenerative diseases, there is usually a decrease seen in the levels of various metabolites, owing to cell death happening. In psychiatric disorders like schizophrenia, there is an increased glutamate predicted which may cause excitotoxicity, leading to focal neuronal death in the affected regions. Thus, much later in the disease process, one would expect the pyramidal cells to die off, leading to decreased glutamate levels, decreased NAA and choline levels, and further decreased GABA levels as negative feedback inhibition is further decreased.
To the best of our knowledge, there has been no study assessing the efficacy of adjunctive theta tACS in negative symptoms of schizophrenia and one evidencing the changes in metabolites of cerebellum in patients of negative symptoms of schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant 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
- •Diagnosis of Schizophrenia using International Classification of Diseases-11th edition (ICD-11) (WHO, 2019).
- •Patients giving written informed consent.
- •Right-handed patients.
- •Illness duration of equal to or more than 2 years.
- •The Positive and Negative Syndrome Scale for Schizophrenia (PANSS) with negative symptoms score of more than
- •Scale for Assessment of Negative Symptoms (SANS) score more than 20.
排除标准
- •Presence of co-morbid neurological or other psychiatric disorder(s).
- •Patient with co-morbid substance dependence, except nicotine and caffeine.
- •Patients having any metallic implants in the body.
- •Subjects who have received ECT in past 1 month.
结局指标
主要结局
Cerebellar theta tACS results in a change in the negative symptoms at the end of 10 sessions.
时间窗: Improvement in the scores of PANSS, SANS, CGI at the end of 10 sessions(2 weeks) & 6 weeks as compared to baseline.
次要结局
- Changes in the levels of GABA, Glutamate, Glutamine, NAA & NAAG in cerebellum using Proton MR Spectroscopy post theta tACS administration to cerebellum.(Baseline, at the end of 10 theta tACS sessions(2 weeks).)