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临床试验/NCT01717079
NCT01717079终止不适用

Effect of Transcranial Magnetic Stimulation on Disturbance of Body Shape Perception in Patients With Anorexia Nervosa

University Hospital, Rouen2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2013年5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
终止
发起方
入组人数
22
试验地点
2
主要终点
BSQ-34 scale (Body Shape Questionnaire)

研究概览

简要总结

Anorexia nervosa (AN) is a frequent, potentially life-threatening eating disorder characterized by a resistance to maintaining body weight at or above a minimally normal weight for age and height, an intense fear of weight gain or being "fat" even though underweight, a loss of menstrual periods in girls and women post-puberty and a disturbance in the experience of body weight or shape. Body weight and shape dissatisfaction is linked to the development, maintenance and relapse of AN. Neuroimaging studies have shown that the inferior parietal cortex is involved in body image perception and less activated in patients with AN compared with healthy subjects. Repetitive transcranial magnetic stimulation (rTMS) is used to modulate cortical excitability, and particularly to increase excitability with high-frequency rTMS. The aim of this study was to investigate the effect of "excitatory" high-frequency rTMS over the "hypoactive" inferior parietal cortex of 54 patients with AN.

This randomized, double-blind, placebo-controlled study will compare effective rTMS (2000 ten-Hz stimulations per session, applied at 90% of the resting motor threshold, with 10 sessions in two weeks) versus placebo rTMS.

Assessments will be performed before rTMS and after the last rTMS session (immediately after, at 15 days and three months). The principal criteria for judgement is a body image satisfaction scale (Boby Shape Questionnaire, BSQ-34). The secondary criteria for judgement are eating behaviour scales (Eating Attitude Test, EAT-40; Bulimia test, BULIT and Eating Disorders Inventory, EDI-2), the Hamilton depression rating scale and Hamilton anxiety rating scale, a quality of life scale (Short-Form Health Survey, SF-36), a body composition analysis using a Dual-energy X-ray absorptiometry and the alpha-MSH autoantibodies levels (biomarker for eating disorders recently described).

Inferior parietal cortex rTMS could not only improve body image perception, but also help in the treatment of eating disorders, allowing weight gain with a decreased anxiety and improving patients' quality of life. Also positive results could have direct therapeutic implications with the possibility to complete regular rTMS sessions, or to implant extradural electrodes for chronic parietal cortex stimulation.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age above 18
  • Restrictive anorexia nervosa with a disease duration more than one year and less than three years.
  • Body Mass Index below 16
  • Patient receiving or having received optimal treatment for anorexia nervosa
  • Right-handed
  • Normal blood ionogramme
  • Previous stable antidepressor treatment for one month and no expected modification in the three following months
  • Patients arriving by car with someone else or by public transportation

排除标准

  • Pregnancy
  • Contraindication to transcranial magnetic stimulation i.e. pace-maker, cardiac valve protheses, metallic protheses etc.
  • History of epileptic seizure
  • Cerebral lesion of any etiology (post-traumatic, tumoral, vascular etc.)
  • History of previous rTMS

研究组 & 干预措施

Effective arm

Active Comparator

Effective coil

干预措施: rTMS (Procedure)

Placebo arm

Placebo Comparator

Placebo coil

干预措施: Sham rTMS (Procedure)

结局指标

主要结局

BSQ-34 scale (Body Shape Questionnaire)

时间窗: Just after rTMS

次要结局

  • EAT-40 scale (eating attitude test)(Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS)
  • BULIT scale (bulimia test)(Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS)
  • Quality of Life Scale, MOS 36 Item Short-Form Health Survey or SF-36(Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS)
  • The body mass index(Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS)
  • body composition analysis using dual energy X-ray absorptiometry(Before rTMS and 3 months after rTMS)
  • autoantibodies against alpha-melanocyte stimulating hormone(Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS)
  • The adverse effects(After rTMS)
  • EDI-2 scale (eating disorder inventory)(Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS)
  • BSQ-34 scale (Body Shape Questionnaire)(Before rTMS, 15 days after rTMS and 3 months after rTMS)
  • Hamilton scale(Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMSBefore rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS)
  • Weight(Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS)

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (2)

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