Neuroanatomical and Neurophysiological Basis of Motor Recovery Associated With Treatment of Recent Stroke Using Amphetamine and Physical Therapy
0-15 Water
Enfermedades del Cerebro+7
+ Enfermedades Cardiovasculares
+ Enfermedades del Sistema Nervioso Central
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de abril de 1998
Fecha en la que se inscribió al primer participante.The purpose of this study is to determine if administration of dextroamphetamine (amph) linked with customarily used Rehabilitation Medicine accelerates motor recovery after stroke. Additionally, if motor recovery occurs, this study will allow identification of the brain regions activated in association with this recovery. Techniques used will include longitudinal rating of motor function, neuro-imaging with positron emission tomography (PET) and functional magnetic resonance tomography (fMRI), electroencephalography (EEG) and transcranial magnetic stimulation (TMS). Patients will be assigned to one of the two groups: amph linked with PT, and placebo linked with PT. Every patient will receive the standard of care PT. Motor recovery will be evaluated in the two groups. If motor recovery is accelerated in any of the groups, then neuroimaging and neurophysiological data will allow identification of areas and networks in the brain associated with this recovery. This is a Phase II study with potential major impact on how stroke patients are treated.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 34 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
INCLUSION CRITERIA: Hemiparetic patients (right or left) (defined as a score of 55 or lower on Fugl-Meyer Scale) who had a single thromboembolic non-hemorrhagic infarction (documented by CT or MRI) 5 to 30 days before. Patients will be recruited from referrals from the community particularly from Suburban Hospital. EXCLUSION CRITERIA: Large hemorrhagic or brain stem stroke. Multiple cerebral lesions with residual deficits. Less than 5 days after stroke or greater than 30 days after stroke. Age younger than 18 or older than 80 years. History of head injury with loss of consciousness. Terminal illness such as AIDS or cancer. Severe neurological diseases other than stroke. History of severe alcohol or drug abuse. History of psychiatric illness. Unstable cardiac dysrhythmia or unresponsive arterial hypertension (greater than 160/100 mmHg). Untreated hyperthyroidism. Receiving alpha-adrenergic antagonists or agonists. Receiving major/minor tranquilizers, clonidine, prazosin, phenytoin, GABA, benzodiazepines, scopolamine, haloperidol, other neuroleptics, barbituates. Degree of aphasia or cognitive deficit that makes patients unable to give informed consent. Pregnancy. A pregnancy test will be done on admission.
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, United StatesAbrir National Institute of Neurological Disorders and Stroke (NINDS) en Google Maps