EUCTR2005-004215-30-GB进行中（未招募）1 期
Imaging the neural correlates of cholinergic and behaviour driven rehabilitation in patients with Wernicke’s aphasia: a double-blinded, cross-over, randomised controlled trial. - Imaging the neural correlates of rehabilitation in Wernicke’s aphasia.
Joint Sponsorship: University College London (UCL) & University College London Hospitals (UCLH)0 个研究点目标入组 60 人开始时间: 2006年1月30日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •60 Patients with a Wernicke-type aphasia caused by a stroke will be recruited, that is: those with either a deficit in auditory processing of normal speech, or with a speech error pattern consistent with this syndrome (high-output, paraphasic or jargon aphasia), or both. It is likely that these patients will have sustained damage to the dominant temporal lobe or its connections as judged by CT/MRI scans. Subjects will be English native speakers; those with significant medical or psychiatric co-morbidity will be excluded, as will those with an absolute contraindication to either donepezil or MRI scanning. Patients will be in the post-acute phase (>3 month post stroke), but those with a chronic deficit may also be included as these patients can benefit from even quite late intervention. These subjects will be studied longitudinally over 7 time points, to assess the effects of the two therapeutic interventions.
- •Patients with Wernicke-type aphasia will be recruited. That is, those with either a deficit in auditory processing of normal speech, or with a speech error pattern consistent with this syndrome (high-output, paraphasic or jargon aphasia), or both. The language deficit will have to be of a sufficient severity for the patients or their carers to complain of communication problems. Other criteria (and associated justifications):
- •Subjects will be English native speakers.
- •Subjects will be over the age of 18.
- •Patients will not be entered into the treatment part of the trial until three months or more has elapsed after their aphasic stroke (to allow for acute changes in cerebral auto-regulation to normalize and for early ‘spontaneous’ recovery of language function to have largely occurred. See Appendix 2 for graphs depicting rates of recovery over time).
- •There will be no upper limit of time since aphasic stroke (patients with a chronic deficit can benefit from even quite late intervention).
- •Only consent competent patients will be enrolled.
- •30 normal, aged-matched volunteers will also be recruited. These subjects will be right-handed, English native speakers. Those with significant medical or psychiatric co-morbidity will be excluded, as will those with an absolute contraindication to MRI scanning. Control subjects will be tested in the same manner as patients but only studied once and not exposed to either therapy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Significant medical or psychiatric co-morbidity (unable to comply with: either the treatment regime, including the computer-based BT; or scanning (lying flat for up to 1.5 hours at a time)).
- •Clinical or neuroimaging evidence of significant multifocal cerebral disease (it will be difficult to interpret functional neuroimaging data).
- •Patients with contraindications to cholinesterase inhibitors (sick sinus syndrome, pregnancy).
- •Patients with contraindications to fMRI/MEG (pacemaker, non-compatible metallic implant, etc (see FIL scanning checklist for other absolute and relative contraindications)).
- •Severe hearing impairment (this will be checked using an audiometer).
- •Less than 18 years old.
- •Patient unable to provide informed consent (see written and pictorial information sheets for patients and their carers)
- •Normal subjects:
- •Significant medical or psychiatric co-morbidity.
- •Contraindications to fMRI/MEG (pacemaker, non-compatible metallic implant, etc (see FIL scanning checklist for other absolute and relative contraindications)).
- •Severe hearing impairment.
- •Less than 18 years old (this population needs to be age-matched to the patient group).
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