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临床试验/NCT05221632
NCT05221632招募中不适用

Accelerated cTBS and 1HZ-rTMS in the Treatment of Obsessive-compulsive Disorder With Individualized Stimulation Target

Anhui Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月1日最近更新:
适应症
干预措施

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
Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale

研究概览

简要总结

The therapeutic effects of high-dose accelerated continue theta-burst stimulation (acTBS) and 1-Hz repetitive transcranial magnetic stimulation (rTMS) on obsessive-compulsive disorder (OCD) and its neural mechanism were investigated by functional MRI.

详细描述

All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after transcranial magnetic stimulation (rTMS) treatment. Patients were randomly allocated to 1-Hz rTMS group,acTBS group and sham group. Patients ware allocated by random number. The decision to enroll a patient was always made prior to randomization. The 1-Hz rTMS group received one round of stimulation every day for 30 minutes with a total stimulation of 1800 pulses for 5 consecutive days. Patients in the acTBS group received 10 two-minute rounds of stimulation each day, spaced 50 minutes apart, with a total of 18,000 pulses for five days.

Before the TMS treatment, Y-BOCS, Obsessions Symptom Scale revised (OCI-R), Hamilton Depression Scale (HAMD-17) and Hamilton Anxiety Scale (HAMA-14) were obtained by a trained investigator to assess baseline severity and other symptoms. The patients had receiving a battery measure of neuropsychological tests (standardized tests to investigate their cognitive problems, anxiety and depressive symptoms in daily life), magnetic resonance imaging scan in multimodalities。

After the last treatment, Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), OCI-R, HAMD-17 and HAMA-14 were obtained, as well as the Global Index of Safety to assess adverse events of the treatment. Patients were instructed to focus their answers on the past 5 days.The patients had also receiving a battery measure of neuropsychological tests and magnetic resonance imaging scan in multimodalities.

Participants were interviewed for two and four weeks after their last treatment to obtain a Y-BOCS score, and they were asked to focus their answers on the past week.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Clinical diagnosis of obsessive-compulsive disorder
  • •Voluntarily participated and cooperated with the experiment.

排除标准

  • •History of significant head trauma or neurological disorders.
  • •Alcohol or drug abuse.
  • •Organic brain defects on T1 or T2 images.
  • •History of seizures or unexplained loss of consciousness.
  • •Family history of medication refractory epilepsy.
  • •Recent aggression or other forms of behavioral dyscontrol.

研究组 & 干预措施

accelerated continue theta-burst stimulation

Experimental

Fifty intermittent TBS sessions (1800 pulses per session, 50 minute inter-session interval ) were delivered as ten daily sessions over five consecutive days at 80% resting motor threshold (RMT). The MRI data set should be collected before the first cTBS session and after the last cTBS session.

干预措施: Accelerated transcranial magnetic stimulation with real coil (Device)

1-HZ repetition transcranial magnetic stimulation Stimulation

Active Comparator

The repetition transcranial magnetic stimulation(rTMS) lasted 30 mins and delivered at 1 Hz with 1s duration, a total of 1800 pulses at 80% of the rest motor threshold (RMT) . MRI dataset should be acquired before the first rTMS session and after the last rTMS session.

干预措施: Transcranial magnetic stimulation with real coil (Device)

accelerated continue theta-burst stimulation (sham)

Sham Comparator

Fifty intermittent TBS sessions (1800 pulses per session, 50 minute inter-session interval ) were delivered as ten daily sessions over five consecutive days at 80% resting motor threshold (RMT). The MRI data set should be collected before the first cTBS session and after the last rTMS session. No actual magnetic stimulation was applied on the head of the volunteers. MRI dataset should be acquired before the first cTBS session and after the last cTBS session.

干预措施: Transcranial magnetic stimulation with sham coil (Device)

结局指标

主要结局

Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale

时间窗: pre-treatment; 1 day post-treatment; Change from baseline score at 1 month

The Yale-Brown Obsessive Compulsive Scale is a test to rate the severity of obsessive-compulsive disorder symptoms, which measures obsessions separately from compulsions. The scale includes 10 items, the first 5 items are evaluated obsessions, the rest are assessments compulsions. Each item 0-4 points, a total of 40 points. The lower the score, the better the outcome.

次要结局

  • Stroop word test(pre-treatment; 1 day post-treatment)
  • Hamilton Depression Scale(HAMD)(pre-treatment; 1 day post-treatment)
  • Hamilton Anxiety Scale(HAMA)(pre-treatment; 1 day post-treatment)
  • Obsessive Compulsive Inventory-Revised (OCI-R)(pre-treatment; 1 day post-treatment)
  • Behavioral index TMT=TMT-B reaction time - TMT-A reaction time.(pre-treatment; 1 day post-treatment)

研究者

发起方
Anhui Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chunyan Zhu

A/Prof.

Anhui Medical University

研究点 (1)

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