Modulating the Left - Anterior Temporal Lobe with Intermittent theta Burst Stimulation to target Language and Cognitive dysfunctions in patients with schizophrenia: An Open label Pilot study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Verbal fluency Test scores.
研究概览
简要总结
This open label single arm study will look at targeting anterior temporal lobe using iTBS (intermittent theta burst) as potential method of alleviating language and cognitive dysfunctions seen in patients with schizophrenia. In addition it will also look at understanding the neural correlates of language and cognitive dysfunctions that occur in this disorder. A target sample of 30 participants will recruited who will receive treatment of 5 days with MRI, Language and cognitive tests will be done before and after treatment.
Aim(s) Evidence suggests that inhibiting the left ATL using cTBS leads to a deceleration in semantic processing speed, accompanied by structural and functional connectivity alterations at the stimulation site and areas functionally linked to the left ATL (Jung and Lambon Ralph, 2021). Moreover, this decline in semantic cognition due to cTBS over the left ATL is influenced by the baseline excitatory-inhibitory balance of the region, contributing to inter-individual variability in responses. This highlights the importance of examining the biological factors in this region alongside behavioural measures to comprehend individual-level response differences.
In light of these findings, which establish a connection between left ATL modulation and alterations in semantic cognition in healthy individuals, coupled with the observed language and cognitive deficits in patients with schizophrenia that are associated with the ATL, these collective insights form the basis for our study hypothesis. Our study aims to investigate
A. Primary a. To examine the effects of intermittent Theta Burst Stimulation (iTBS) over the left ATL (targeted via their T1 image) on verbal fluency in participants with a diagnosis of schizophrenia.  Hypothesis: iTBS will enhance verbal fluency as measured via categorical-fluency, phonemic-fluency, and picture-based word production tests B. Secondary a. To examine the effects of iTBS over left ATL on global measures of cognition, NLP measures of speech and language, symptoms, and interpersonal functioning.  Hypothesis: iTBS will enhance cognition, and functioning and alleviate symptoms. b. To examine the functional connectivity changes of the left ATL following iTBS during task and rest states  Hypothesis: Patients with poorer performance on Category Fluency task (more errors/decreased number of words) will have decreased activation of left ATL regions. And will have aberrant connectivity to frontal executive networks. c. At baseline to examine TMS-EEG measures over Left ATL (TMS Evoked Potentials) as moderators of verbal fluency change with iTBS.  Hypothesis: The TEP’s measured at baseline will inform about the state dependent dynamics of the ATL which may explain the variance in response to neuromodulation (iTBS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with schizophrenia with capacity to consent.
- •Age range: 18 – 45 years
- •Patients with schizophrenia exhibiting cognitive deficits, defined as BACS scores (any domain) falling 1 or more standard deviations below the mean and standard deviation derived from a local healthy population cohort.
- •Right handed individuals assessed by Edinburgh Handedness scale.
- •Having moderate level of symptoms as measured by a score of 4 or more on Global rating on any domains in SAPS or SANS scale.
- •No contraindication for MRI and TMS (as assessed by TASS checklist)
- •No risk of harm to self or harm to others
- •No active substance use in the last 3 months (apart from nicotine).
排除标准
- •Features suggestive of risk of harm to self (for example: suicidal risk, catatonia, prolonged nutritional deprivation) or others (for example: aggression or excitement)
- •Unstable medical condition
- •History of uncontrolled seizures
- •Co morbid medical or neurological disorder that can affect structure of the brain.
- •Pregnancy or postpartum state
- •Comorbid substance abuse or dependence
- •Significant neurologic disorder
- •Left/mixed Handedness.
结局指标
主要结局
Verbal fluency Test scores.
时间窗: Time point 1 (T1)- Baseline | Time point 2 (T2)- End of intervention of the study i.e End of 10th session (5DAYS) or termination of the trial for any predefined reasons)
次要结局
- 1. Scale for the Assessment of Positive Symptom (SAPS)(2. Scale for the Assessment of Negative Symptom (SANS))
研究者
Dr Kiran Basawaraj Bagali
NIMHANS