Efficacy of Adjuvant Cerebellar Theta Transcranial Alternating Current Stimulation In Cognitive Symptoms of Schizophrenia: An EEG-Based Randomized Sham-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in cognitive symptoms in schizophrenia in CANTAB after 20 sessions of theta tACS.
研究概览
简要总结
Cognitive impairment in schizophrenia is one ofthe most difficult symptom domains to treat with pharmacotherapy andpsychotherapy available at present.
Noninvasive neuromodulation techniques useeither magnetic or electrical stimulation to directly target specific brainareas, alter neuronal oscillations, cause long-term neuroplasticity changes. Variousneuromodulation techniques including rTMS, tDCS, tRNS, tACS etc. are found tobe well tolerated. Their effect in improving cognitive impairments inschizophrenia is found to be equivocal. Evidence is limited due to majority ofresearch having small sample size, some having contradictory findings and lackof evidence regarding long-term efficacy. (Kar and Singh, 2022) tACS is moreeffective at entraining the endogenous brain oscillations as compared to tDCS asit mimics the alternating nature of brain oscillations. (Elyamany et al., 2021)
According to a study by Parker et. al. (2014),considering the extensive anatomical connection between cerebellum, thalamus, prefrontaland anterior cingulate cortex, cerebellar stimulation may restore prefrontalfunction and improve cognition in schizophrenia. No serious adverse event wasreported in any study administering tACS to cerebellum in healthy or diseasedpopulation. Singh et. al. conducted a study where single session of theta tACSwas applied on cerebellar vermis in schizophrenia patients which led to changesin theta activity in frontal cortex but no significant change in performance ona core cognitive-timing task, concluding that repeated or longer duration tACSsessions may induce long-lasting or more robust changes in midfrontal oscillatoryactivity at lower frequency bands that may lead to significant behaviouralimprovement. (Singh et al., 2019)
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
- •1.Diagnosis of schizophrenia (6A20) according to International Classification of Diseases, Eleventh Revision (ICD-11), World Health Organization (WHO).
- •2.Patients willing to give informed consent.
- •3.Patients aged between 18-60 years of either sex.
- •4.Illness duration of more than 2 years.
- •5.MoCA score less than or equal to 25.
排除标准
- •1.Presence of comorbid neurological or other psychiatric disorder.
- •2.Presence of comorbid substance use in dependence pattern, except nicotine and caffeine.
- •3.Patients who have received ECT in past 6 month.
- •4.Patients not ready to give informed consent.
结局指标
主要结局
Change in cognitive symptoms in schizophrenia in CANTAB after 20 sessions of theta tACS.
时间窗: Change in cognitive symptoms in schizophrenia in CANTAB after 20 sessions of theta tACS measured at baseline, at 2 weeks and at 6 weeks
次要结局
- Change in relative theta power in EEG after 20 sessions of theta tACS.(Change in relative theta power will be noted by measuring at baseline & at 6 weeks.)
