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| Tracking Information | |
|---|---|
| First Received Date ICMJE | December 27, 2002 |
| Last Updated Date | March 5, 2008 |
| Start Date ICMJE | December 2002 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE |
To establish the maximally tolerated dose of enzastaurin in combination with carboplatin in patients with refractory primary brain tumors not on any enzyme-inducing anti-epileptic drugs (EIAED) and for patients on EIAEDs. |
| Change History | Complete list of historical versions of study NCT00050869 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE |
To obtain exploratory data regarding the relationship between clinical outcome and GSK3-b activation in peripheral blood mononuclear cells in treated patients. |
| Descriptive Information | |
| Brief Title ICMJE | Learning a Motor Task Through Observation |
| Official Title ICMJE | Encoding a Motor Memory by Action Observation |
| Brief Summary | Motor training results in use dependent plasticity (UDP), thought to underlie recovery of motor function after brain injury. The purpose of this protocol is to determine (a) if movement observation results in encoding of a motor memory in the primary motor cortex and (b) if observation of motor training can enhance the effects of physical training in healthy volunteers. If so, this may become an important tool in rehabilitative treatment for patients who are unable or partially able to train. We will test our hypotheses by means of focal single pulse transcranial magnetic stimulation (TMS) in a group of healthy volunteers. Our outcome measure will be the change in TMS-evoked movement direction as a function of training strategy. So far we found that this is the case in healthy volunteers (see data in analysis of the study). The purpose of this amendment is to determine if action observation can elicit the same effects in adult chronic ischemic stroke patients who have had originally significant motor weakness but recovered to the point of being able to perform the motor tasks, possibly resulting in a useful rehabilitative strategy. |
| Detailed Description | Motor training results in use dependent plasticity (UDP), thought to underlie recovery of motor function after brain injury. The purpose of this protocol is to determine (a) if movement observation results in encoding of a motor memory in the primary motor cortex and (b) if observation of motor training can enhance the effects of physical training in healthy volunteers. If so, this may become an important tool in rehabilitative treatment for patients who are unable or partially able to train. We will test our hypotheses by means of focal single pulse transcranial magnetic stimulation (TMS) in a group of healthy volunteers. Our outcome measure will be the change in TMS-evoked movement direction as a function of training strategy. So far we found that this is the case in healthy volunteers (see data in analysis of the study). The purpose of this protocol is to determine if action observation can elicit the same effects in adult chronic ischemic stroke patients who have had originally significant motor weakness but recovered to the point of being able to perform the motor tasks, possibly resulting in a useful rehabilitative strategy. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE | Healthy |
| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * | Strafella AP, Paus T. Modulation of cortical excitability during action observation: a transcranial magnetic stimulation study. Neuroreport. 2000 Jul 14;11(10):2289-92. |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 56 |
| Completion Date | November 2007 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE |
Healthy volunteers and patients with thromboembolic non-hemorrhagic hemispheric lesions at least 6 months after the stroke, aged 18 to 80 years. 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, and those in whom isolated thumb movements can be evoked by TMS. Handedness will be assessed by the Edinburgh inventory scale. Subjects should be able to sustain attention to the task over 30 minutes. EXCLUSION CRITERIA History of surgery with metallic implants or known history of metallic particles in the eye. Patients with cardiac pacemaker, neural stimulators, cochlear implants, implanted medication pumps. Patients with history of alcohol and drug abuse, psychiatric illness (depression, attention deficit disorder, or dementia). Patients with severe uncontrolled medical problems (e.g. cardiovascular diseases, hypertension, diabetes mellitus, arthritis, active cancer, renal, liver, severe pulmonary diseases, infectious diseases). Patients with epilepsy or history of loss of consciousness. Patients with use of medications that influence synaptic plasticity as evaluated by the investigator, like antipsychotic, antidepressant acting drugs, benzodiazepines. Patients above 80 and less than 18 years of age. Children. Pregnant women in the last trimester. Patients with more than one stroke in the middle cerebral artery territory. Patients with bilateral motor impairment. Patients with cerebellar or brainstem lesions. Patients unable to perform the task (wrist or elbow flexion at least MRC grade 2). Patients with unstable cardiac arrhythmia. Patients with h/o hyperthyroidism or individuals receiving drugs acting primarily on the central nervous system that lower the seizure threshold or influence synaptic plasticity like neuroleptics, benzodiazepines, tricyclic antidepressants, antiepileptic medication. |
| Gender | Both |
| Ages | 18 Years to 80 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00050869 |
| Responsible Party | |
| Study ID Numbers ICMJE | 030074, 03-N-0074 |
| Study Sponsor ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | November 2007 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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