Targeting the adenosinergic system in restless legs syndrome: a proof-of-concept” placebo-controlled transcranial magnetic stimulation-based protocol

Oasi Research Institute-IRCCS0 个研究点目标入组 30 人开始时间: 2024年2月13日最近更新: 2024年5月27日

试验速览

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38728342/ (added 14/05/2024)

•1. Age 18-65 years
•2. Diagnosis of RLS according to the latest criteria by the International RLS Study Group
•3. RLS symptoms on 3 or more days per week for at least 3 months
•4. International RLS Rating Scale (IRLS-RS) score >15 (i.e., moderate symptomatology, at least)
•5. Normal brain magnetic resonance imaging (MRI) and upper limb electromyography (EMG), including the study of the F-waves
•6. Women of childbearing potential must have a negative pregnancy test and agree not to become pregnant during the whole experimental procedure
•7. Personally signed and dated informed consent obtained before any procedure. All personal information about potential and enrolled participants will be collected and maintained, in order to protect confidentiality before, during, and after the whole procedure

•1. Drug intake affecting cortical excitability or cognitive performance, including those used for RLS
•2. Mini Mental State Examination score <24
•3. Any major psychiatric disease
•4. Other neurological or sleep disorders
•5. Severe, untreated, acute, or not compensated medical illness
•6. Any secondary form of RLS (i.e. renal failure, anemia, low serum iron and ferritin levels, pregnancy, peripheral neuropathy, etc.)
•7. Contraindication to dipyridamole and/or caffeine intake
•8. Any condition precluding MRI or TMS execution, such as the presence of a cardiac pacemaker, defibrillator, or mechanical valve, presence of non-compatible joint prostheses, previous neurosurgical procedures, and, for TMS only, seizure or history of epilepsy. A conventional EEG will be also performed in order to exclude a predisposition to seizure.

发起方

Oasi Research Institute-IRCCS