Mexiletine for the Treatment of Focal Dystonia
关键词
抽象
描述
Dystonia is a complex neurological disorder with an unknown pathogenesis likely involving the basal ganglia. There is no adequate treatment for dystonia. Recent studies using intramuscular and intravenous lidocaine have shown improvement in dystonic movements. It has been proposed that patients with dystonia have reduced presynaptic inhibition of alpha motoneurons leading to overactivation in response to movement. This may also reflect a hyperexcitability at the cortical level, which can be reduced by altering peripheral input.
Mexiletine, an antiarrhythmic similar to lidocaine, but available orally, may benefit patients with dystonia, as has been shown in several recent open-label studies. This trial offers the possibility of treating dystonia as well as further elucidating the level of dysfunction in the nervous system in dystonic patients. We propose a double-blind cross over study comparing mexiletine to placebo in the treatment of patients with idiopathic dystonia. The patients will be evaluated by clinical rating scales as well as neurophysiological studies. In order to study the physiologic effect and attempt to localize the neuroanatomic sight of action of mexiletine, studies of peripheral reflexes, reciprocal inhibition and cortical excitation will be performed. These studies will include blink reflex recovery curves, tonic vibration reflex, H-reflex and transcranial magnetic stimulation.
日期
最后验证: | 06/30/2002 |
首次提交: | 11/02/1999 |
提交的预估入学人数: | 11/02/1999 |
首次发布: | 11/03/1999 |
上次提交的更新: | 03/02/2008 |
最近更新发布: | 03/03/2008 |
实际学习开始日期: | 06/30/1998 |
预计完成日期: | 06/30/2002 |
状况或疾病
干预/治疗
Drug: Mexiletine
相
资格标准
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | INCLUSION CRITERIA: Patients with focal dystonia, specifically writer's cramp and blepharospasm, will be eligible for study. Patients will need medical clearance, specifically, cardiac clearance, by their primary care physician. This will include an EKG within the past 12 months and no history of underlying cardiac disease. EXCLUSION CRITERIA: Patients with any of the following conditions will be excluded from the study: structural brain lesions, identifiable etiology for dystonia (such as stroke, trauma, Parkinson's Disease, Wilson's Disease, or peripheral neuropathy), contractures or fixed joint deformities, current or past use of neuroleptics, seizures, prior neurosurgery, or co-existent neurologic or general medical illness, including history of cardiovascular disease or peptic ulcer disease and pregnant or breast-feeding women. Patients who are taking or have taken mexiletine will be excluded as well. |