Bilateral Deep Brain Stimulation of Forel's H Field in Tourette's Syndrome: Prospective, Randomized, Crossover, Double-blind Study
试验速览
- 阶段
- 不适用
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Percent of change in the score of Yale Global Tic Severity Scale (YGTSS) pré and pós stimulation, comparing device On(active) and device OFF (sham) conditions.
研究概览
简要总结
Tourette's Syndrome (TS) is a neurodevelopmental disease characterized tics that start before the age of 18 years. About 5% of cases do not respond to drug treatment and can be classified as refractory and in these cases surgical treatment, with deep brain stimulation, appears as a therapeutic possibility, but with still conflicting results. Our hypothesis is that DBS in Forel's H Field could improve tourette's symptoms, neurological and psychiatric ones.
详细描述
Sixteen patients with TS will be included in our protocol. The tics must have a negative influence in the quality of life of these patients. Patients will be submitted to a neuronavigation protocol for the precise location of the surgical target. After the surgery all patients will have the device turned ON for 6 months.
After the first 6 months participants will be randomly in two groups, one to stay with device ON or turned OFF at a period of 3 months. After that the groups will cross over for more 3 months. Clinical and video evaluations will be conducted before the surgery, at end of open fase, in the moment of cross over and at end of all.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Tourette's Syndrome diagnosis.
- •Age equal to or above 14 years.
- •Severe impairment of motor tics (Yale Global Tic Severity Scale ≥ 35/50).
- •Patients who are refractory to drug treatment.
- •Patients intellectually able to understand and sign the consent form.
- •Possibility to adhere to research and periodic medical visits after surgery.
排除标准
- •Inability to consent to your participation in the study.
- •Patients with non-stabilized psychiatric comorbidities, such as anxiety and depression.
- •Concomitant treatment with other experimental drugs.
- •Women who are pregnant or breastfeeding.
- •Patients undergoing previous neurosurgical procedures for the treatment of Tourette's Syndrome.
结局指标
主要结局
Percent of change in the score of Yale Global Tic Severity Scale (YGTSS) pré and pós stimulation, comparing device On(active) and device OFF (sham) conditions.
时间窗: month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.
Assess 5 items: number, frequency, intensity, complexity, interference. Each item is scored for phonic and motor tic symptom by the patient on a 0 to 5 numerical scale. The maximum possible score for these part is 50. Add to that the impairment score, which also has 50 as the maximum score. Total Yale Global Tic Severity Scale Score (Total Tic Severity Score + Impairment). The maximum possible score for the total scale is 100. Lower scores of YGTSS represents less tics.
次要结局
- Change in Quality of Life(month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.)
- assessment of structural connectivity patterns(month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.)
- Change in psychiatric symptom - obsessive-compulsive disorder(month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.)
- Change in psychiatric symptoms - Anxiety(month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.)
- Change in psychiatric symptom - attention deficit hyperactivity disorder(month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.)
- Change in psychiatric symptom - Depression(month 0: baseline; month 8: end off open label phase. All patients had de device ON for 6 months. month 11: after 3 months of device ON or OFF. month 14: after 3 months of device in opposite situation at evaluation at month 11.)
研究者
Rubens Gisbert Cury
Medical Assistant, Movement Disorders Unit. Principal Investigator. MD, PhD
University of Sao Paulo General Hospital