Altered Brain GABA and Glutamate in Restless Legs Syndrome

Completed

Conditions studied: Restless Legs Syndrome

In brief

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.

Key facts

Study ID

NCT01109537

Run by

Brigham and Women's Hospital

People needed

75

Starts

2010-04-01

Expected to finish

2014-05-01

Last updated by the study team

2015-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sleep HealthCenters — Brighton, Massachusetts, United States

Full record on ClinicalTrials.gov

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