跳至主要内容
临床试验/CTRI/2022/09/045759
CTRI/2022/09/045759招募中不适用

To investigate the combined neuromodulatory effects of intermittent theta burst stimulation (iTBS) and probiotics on gut-brain axis in Parkinson’s disease – a randomized controlled trial.

ICMR1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
After 12 weeks Intermittent theta burst stimulation and probiotics will improve motor symptoms and neural plasticity along with changes in gut-brain axis in PD Patients.

研究概览

简要总结

Parkinson’s disease (PD) is a progressive neurodegenerative disease characterized by the loss of dopamine neurons in the substantia nigra pars compacta. Gastrointestinal (GI) dysfunction is one of the most common non-motor symptoms of Parkinson’s disease. Abnormal gastric motility and delayed gastric emptying occur in early-stage PD even prior to pharmacological treatment, which is attributed to alterations in gut microbiota.  Neurogenic orthostatic hypotension (nOH), is a potentially serious manifestation of cardiovascular sympathetic failure that occurs in approximately 30% of patients with PD. Recently, transcranial magnetic stimulation (TMS) has been used extensively to modulate the cortical plasticity via non-invasive magnetic stimulation applied to the motor cortex. Evidence suggests probiotics may decrease pro-inflammatory cytokines, oxidative stress, and potentially pathogenic bacterial overgrowth in patients with PD. The present study is designed to unravel the therapeutic role of single-session (excitatory) intermittent theta burst stimulation (iTBS) of motor cortex along with probiotics on gut brain axis and neurogenic orthostatic hypotension in PD patients. A Battery of questionnaires, blood pressure assessment, electrogastrography (EGG), cortical excitability will be recorded and correlated with the motor cortex excitability of the PD patients. Thus, the present study will be helpful in mitigating the disease complexity of PD by the novel, non-invasive combinatorial strategy over classical pharmacological based approaches.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
40.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients should be on stable diet and any other intervention/ new drug must not be started at least one month prior to the recruitment.

排除标准

  • Use of vasoconstriction agents or long-acting antihypertensive medications.
  • Other causes of neurogenic orthostatic hypotension except Parkinson disease.
  • Presence of any metal implant.
  • History of seizure and other severe mental illness.

结局指标

主要结局

After 12 weeks Intermittent theta burst stimulation and probiotics will improve motor symptoms and neural plasticity along with changes in gut-brain axis in PD Patients.

时间窗: 1. All scales and Parameters (MDS-UPDRS, corticomotor | excitability parameters, Electrogastrography Assessment) will be recorded at Baseline (immediately after recruitment) | 2. After 12 weeks of probiotic supplementation, MDS-UPDRS, corticomotor | excitability parameters, Electrogastrography Assessment will be done.

次要结局

  • The combinatorial therapeutic strategy of probiotics along with intermittent theta bust stimulation will be able to restore the non-motor and autonomic nervous system functions in PD patients.(1. Base line assessment (after recruitment) of Orthostatic hypotension questionnaire: Orthostatic hypotension symptom assessment (OHSA) and Orthostatic hypotension daily activity scale (OHDAS), Supine, sitting and standing blood pressure assessment will be done.)

研究者

发起方
ICMR
申办方类型
Government funding agency

研究点 (1)

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