"Neuroband": The Effect of Perioperative Enhancement of the Brain Circuit of Inhibitory Control in Obese Patients Undergoing Laparoscopic Adjustable Gastric Banding (LAGB)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Weight Change
研究概览
简要总结
In this project the investigators aim to improve eating control and weight loss outcomes in patients undergoing LAGB with an innovative brain-based intervention. Specifically, the investigators will enhance the activity of the right inferior frontal gyrus, a core region of the brain circuit of inhibitory control, using transcranial direct current stimulation (tDCS).
详细描述
Laparoscopic Adjustable Gastric Banding (LAGB) is a minimally invasive and reversible procedure in bariatric surgery that has a good safety record. Despite these advantages, success rates following LAGB are quite variable across individuals. Recent data suggest that complementing LAGB with interventions targeting factors along the brain-behavior spectrum could enhance weight loss results following this procedure.
The study will have the following three aims:
Aim #1: To evaluate whether enhancement of the right inferior frontal gyrus with tDCS in patients undergoing LAGB can improve inhibitory control capacity. For this aim the investigators will evaluate participants' performance in a computerized test of inhibitory control. Results from this aim will provide evidence for target engagement, and thus confirm that the brain circuit of interest was affected as a result of the intervention.
Aim #2: To examine whether enhancement of the right inferior frontal gyrus with tDCS in patients undergoing LAGB can lead to improvements in a self-reported measure of eating control (disinhibition subscale of the three-factor eating questionnaire). Results form this aim will provide evidence for an effect of the intervention on an intermediate, behavioral variable.
Aim #3: To preliminary evaluate whether enhancement of the right inferior frontal gyrus with tDCS in patients undergoing LAGB can improve postoperative weight loss outcomes. This aim will provide preliminary evidence for the clinical efficacy of the intervention over a time window period of 12 months. Weight loss at 12 months will be the primary outcome of the study.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 20-55 years old
- •BMI: 35-60 kg/m2
- •Planning to undergo or having undergone laparoscopic adjustable gastric banding (LAGB) within the previous week
排除标准
- •Unstable medical conditions including poorly controlled diabetes and hypertension
- •Pregnancy or planning pregnancy during study period
- •Personal or family history of epilepsy or other unexplained loss of consciousness
- •Current or past medical history of skin disease or damaged skin on the scalp at site of stimulation
- •Active psychiatric or neurological condition
- •Prior neurological procedure
- •Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculoperitoneal shunt
- •Intake of common medications that affect the central nervous system will be allowed if determined okay by MD
研究组 & 干预措施
Active tDCS
In this arm, participants will receive active tDCS (2mA, 20 min per session). The anode electrode will be placed over the right inferior frontal gyrus, defined as F8 (10-20 EEG system), with the cathode electrode placed over the contralateral supraorbital area, above the left eyebrow. During each session they will also perform a computerized task designed to engage the inhibitory control circuit when confronted with food stimuli.
干预措施: Transcranial Direct Current Stimulation (tDCS) (Device)
Sham tDCS
Participants will receive sham tDCS sessions with the same duration and electrode montage as in the real tDCS arm. In this case, current will be applied for 30 s only according to standard procedures, and participants will perform a control task where they will observe and provide responses for the same food and non-food pictures as in the active group task, but without requirement of inhibitory control for performance.
干预措施: Transcranial Direct Current Stimulation (tDCS) (Device)
结局指标
主要结局
Weight Change
时间窗: Baseline, 2 weeks after surgery, 10 days of tDCS, 1 month, 3 months, 6 months and 12 months follow up
Participants will be weighed at the indicated time points. Weight loss at 12 months will be the primary outcome of the study.
次要结局
- Eating Disinhibition as Measured by the Three Factor Eating Questionnaire (TFEQ)(Baseline and 12 months follow up)
- Change From Baseline in Inhibitory Control Over Food as Measured by the Stop Signal Reaction Task(12 month follow-up vs. Baseline)
研究者
Miguel Alonso-Alonso, MD
Assistant Professor of Surgery
Beth Israel Deaconess Medical Center