Thalamic and Anterior Cingulate Cortex GABA and Glutamate in Restless Legs Syndrome: A 1-HMRS Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Regional GABA and glutamate levels derived from 4T MRS.
研究概览
简要总结
The purpose of the study is to understand the brain chemistry of people with Restless Legs Syndrome (RLS). The primary hypothesis is that patients with RLS will have reduced GABA levels in their Thalamus and elevated Glutamate levels in their Anterior Cingulate Cortex. The study will use MRS imaging to examine the regional levels of these neurochemicals, GABA and Glutamate, in the brain.
详细描述
The study will involve a screening visit, a washout period for those taking RLS medications, a night of actigraphy, an overnight polysomnogram, an MRI scan, and an MRS scan. The polysomnography and MR scan visits will occur on consecutive days.
Visit 1: Screening Visit
The informed consent process for the study will be completed and a signed informed consent form will be obtained. All subjects with RLS will undergo a clinical interview in order to confirm or exclude an RLS diagnosis consistent with the International Restless Legs Syndrome Study Group criteria and to determine the presence of any psychiatric or medical disorders. The following study assessments will be completed:
- International Restless Legs Syndrome Scale (IRLS) (RLS subjects only)
- Clinical Global Impression-Severity (CGI) (RLS subjects only)
- Insomnia Severity Index (ISI)
- Beck Depression Inventory
- Pittsburgh Sleep Quality Index (PSQI)
- Hamilton Anxiety Scale (HAM-A)
- Sleep Health Centers Questionnaire
- Metal implant questionnaire
All women will have a urine pregnancy test and all subjects will have a urine sample for drug screening collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects at least 18 years of age
- •Subjects with a diagnosis of RLS using the International RLS Study Group (IRLSSG) criteria
- •Subjects with a history of RLS symptoms at least 15 nights in the prior month, or, if on treatment, this frequency of symptoms before treatment was started
排除标准
- •Subjects who are unable to discontinue prohibited medications prior to sleep study and 1H-MRS. These include any CNS-active medications. For RLS subjects, RLS-related medications (e.g. dopaminergic agents and alpha 2-delta agents) must be discontinued a minimum of 48 hours prior to PSG. In the RLS group, benzodiazepines must be discontinued a minimum of one week prior to PSG. For normal controls with regular treatment (>1 time/wk) with CNS active agents within 1 month of screening visit will also be excluded.
- •Subjects with an active or unstable major psychiatric disorder requiring further treatment (e.g., major depressive disorder). Subjects with clinically significant depression, or with clinically significant anxiety, or who, in the investigator's judgment might require intervention with either pharmacological or non-pharmacological therapy over the course of the study.
- •Subjects with clinical evidence of any untreated moderate to severe sleep disorder other than RLS (forRLS group) (e.g. obstructive sleep apnea, insomnia, narcolepsy, delayed sleep phase syndrome, etc.) within the preceding year
- •Subjects with an apnea-hypopnea index (AHI) > 15 at the polysomnography visit
- •Subjects who consume beverages containing more than 400mg of caffeine per day
- •Subjects who consume more than 14 alcoholic units in any week, or more than 5 alcoholic units in any single day, over the month preceding the screening visit.
- •Females who are pregnant or lactating
- •Subjects with a history of neurologic illness (e.g. brain neoplasm, multiple sclerosis), significant or unstable medical illness (e.g. congestive heart failure, diabetes mellitus), or history of significant head trauma or loss of consciousness > 30 minutes
- •Subjects who have positive urine drug screening (phencyclidine, cocaine, amphetamines, tetrahydrocannabinol, and opiates) at the screening visit or at the MRS visit.
- •Contraindications to MRS scans, including:
- •Cardiac pacemakers
- •Aneurysm clips and other vascular stents, filters, clips or other devices
- •Prosthetic heart values
- •Other prostheses
- •Neuro-stimulator devices
- •Implanted infusion pumps
- •Cochlear (ear) implants
- •Ocular (eye) implants or known metal fragments in eyes
- •Exposure to shrapnel or metal filings (sheetmetal workers, welders, and others)
- •Other metallic surgical hardware in vital areas
- •Severe claustrophobia
结局指标
主要结局
Regional GABA and glutamate levels derived from 4T MRS.
时间窗: 2 years
次要结局
未报告次要终点
研究者
John W. Winkelman, MD, PhD
Associate Professor of Psychiatry, Harvard Medical School
Brigham and Women's Hospital