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临床试验/NCT05188833
NCT05188833Unknown不适用

Electrophysiological Results of the Efficacy of Deep Transcranial Magnetic Stimulation on Mood State and Quality of Life in Obsessive Compulsive Disorder Patients

Istanbul Medipol University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年5月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Electroencephalography

研究概览

简要总结

Obsessive Compulsive Disorder (OCD) is a psychiatric disorder in which involuntary thoughts and irresistible behaviors are seen and its prevalence affects 2%-3% of the general population. Deep TMS is a treatment method that provides stimulation of lower parts of the brain and larger brain volume, and in addition to drug treatment and psychotherapy approaches, magnetic stimulation of localized brain regions and disease symptoms are addressed. The presence of the medial prefrontal cortex and anterior cingulate cortex in the dysfunction on the specified cycle seen in OCD patients indicates that the stimulation of these regions is necessary for a meaningful result in the treatment of deep TMS; studies show that the effect of the deep TMS method emerges as a result of the stimulation of these regions. 30 patients with OCD will included into the study and dividen into 3 groups (DTMS (n=10), DTMS + Paroxetine (n=10), Control(n=10)). Patients will evaluated in terms of depression, quality of life, and EEG before and after the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being diagnosed with Obsessive Compulsive Disorder within the framework of DSM-5 criteria

排除标准

  • Not volunteering to comply with the research program
  • Presence of a metal piece on the head
  • Having a pacemaker inserted
  • Having had a previous epileptic seizure

研究组 & 干预措施

Deep Transcranial Magnetic Stimulation

Active Comparator

The treatment will be carried out for 6 weeks, 5 days a week, in total 30 sessions; 20 hz using Brainsway H-7 helmet. It will be applied to the mPFC and ACC simultaneously with a total of 2000 beats at a frequency of 50 beats in each string.

干预措施: Deep Transcranial Magnetic Stimulation (Device)

Deep Transcranial Magnetic Stimulation and Paroxetine

Experimental

The treatment will be carried out for 6 weeks, 5 days a week, in total 30 sessions; 20 hz using Brainsway H-7 helmet. It will be applied to the mPFC and ACC simultaneously with a total of 2000 beats at a frequency of 50 beats in each string. In addtion to DTMMS, paroxetine will applied.

干预措施: Deep Transcranial Magnetic Stimulation (Device)

Deep Transcranial Magnetic Stimulation and Paroxetine

Experimental

The treatment will be carried out for 6 weeks, 5 days a week, in total 30 sessions; 20 hz using Brainsway H-7 helmet. It will be applied to the mPFC and ACC simultaneously with a total of 2000 beats at a frequency of 50 beats in each string. In addtion to DTMMS, paroxetine will applied.

干预措施: Paroxetine (Drug)

Paroxetine

Active Comparator

Paroxetine is a type of antidepressant known as an SSRI (selective serotonin reuptake inhibitor). It's often used to treat depression in OCD.

干预措施: Paroxetine (Drug)

结局指标

主要结局

Electroencephalography

时间窗: 6 weeks after baseline

It is an electrophysiological neuroimaging method frequently used in neuroscience and clinic, in which the activity between neural circuits can be measured and observed non-invasively in the form of electrical waves.

次要结局

  • Beck Depression Scale(6 weeks after baseline)
  • World Health Organization Quality of Life Scale Short Form(6 weeks after baseline)

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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