Improvement of Use Dependent Plasticity in Chronic Stroke Patients
Colección de datos
Trastornos Cerebrovasculares+3
+ Enfermedades del Sistema Nervioso Central
+ Enfermedades Cardiovasculares
Estudio de Tratamiento
Resumen
Fecha de inicio: 6 de noviembre de 2003
Fecha en la que se inscribió al primer participante.OBJECTIVES: There is no universally accepted strategy to promote recovery of motor function after chronic stroke, the main cause of long-term disability among adults. It is desirable to develop strategies to enhance motor training in this patient group. A recent study in stroke patients and healthy volunteers demonstrated that somatosensory nerve stimulation prior to motor training leads to improvements in use-dependent plasticity (UDP), a process thought to underlie recovery of motor function after brain injury (Sawaki et al., unpublished information). Interestingly, the effects of sensory input on cortical plasticity can be enhanced by a single dose of amphetamine. The objective of this protocol is to further enhance the effect that somatosensory nerve stimulation has on motor training by means of pre-medication with amphetamine. This effect over motor training will be measured by the magnitude of training-induced UDP. Our hypothesis is that the amphetamine-enhanced effects of somatosensory nerve stimulation will increase the magnitude of training-induced UDP. STUDY POPULATION: We plan to study 24 patients with chronic strokes and 24 healthy age- and gender matched normal volunteers. DESIGN: All subjects will participate in 5 different randomized sessions on separate days. The first session will be a familiarization with the behavioral tasks. A second experiment will consist of training with no further interventions to obtain baseline UDP changes. In another two sessions, subjects will be premedicated in a blind manner with amphetamine or placebo before administration of somatosensory nerve stimulation followed by motor training to induce UDP. In the last experiment, the participants will be premedicated with amphetamine and will be exposed to sham somatosensory stimulation prior to the motor training to induce UDP. OUTCOME MEASURES: Primary outcome measure will be the magnitude of UDP (training-induced changes in transcranial magnetic stimulation-evoked kinematic responses). Secondary outcome measures are pinch force; and a functional measure of activities of daily life (ADL): Jebsen-Tailor-Test. To better understand the mechanisms underlying the proposed behavioral gains, we will use TMS to identify changes in corticomotor excitability.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 48 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.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
* INCLUSION CRITERIA: We will include patients with thromboembolic non-hemorrhagic hemispheric lesions at least 12 months after the stroke. We will choose patients who initially had a severe motor paresis (below MRC grade 2), which subsequently recovered to the point that they have a residual motor deficit but can perform the required tasks. As a control group, we will include age- and gender matched normal volunteers with matched non-dominant/dominant hand (to the affected hand of the stroke patients). EXCLUSION CRITERIA: Patients with more than one stroke in the middle cerebral artery territory. Patients with bilateral motor impairment. Patients with cerebellar or brainstem lesions. Patients receiving alpha-adrenergic antagonists or agonists, major/minor tranquilizers, clonidine, prazosin, phonation, benzodiazepines, scopolamine, haloperidol, other neuroleptics, barbiturates and MAO inhibitors. Patients or normal volunteers unable to perform the task (wrist or elbow flexion at least MRC grade 2). Patients or normal volunteers with history of severe alcohol or drug abuse, psychiatric illness like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 23 or less). Patients or normal volunteers with severe uncontrolled medical problems (e.g. hypertension, cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, uncontrolled epilepsy or others). Patients or normal volunteers with increased intracranial pressure as evaluated by clinical means. Patients or normal volunteers with unstable cardiac arrhythmia. Patients or normal volunteers with history of hyperthyroidism or individuals receiving drugs acting primarily on the central nervous system. Patients and normal volunteers with more than moderate to severe microangiopathy, polyneuropathy, diabetes mellitus, or ischemic peripheral disease. Pregnancy. Patients and normal volunteers less than 18 years of age. Lactating women.
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 Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United StatesVer ubicación