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临床试验/NCT00567242
NCT00567242已完成1 期

Treating Intention In Aphasia: Neuroplastic Substrates

University of Florida6 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2007年3月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
14
试验地点
6
主要终点
Lateralization of Frontal Lobe (and Posterior Perisylvian) Activity During Word Production

研究概览

简要总结

The purpose of this study is to determine if an "intentional act" improves treatment response for patients with nonfluent aphasia. The treatment involves naming pictures and saying members of categories. The "intentional act" requires initiating picture naming or category member trials with a left-hand movement sequence. Nonfluent aphasia is a disorder of language production in which patients with damage to the brain's language system have trouble initiating and maintaining spoken communication. All patients participating in the study take part in functional MRI scans to determine how treatments affect brain systems.

详细描述

A new treatment manipulating intention substrates for language production in "nonfluent" aphasia patients was developed. The intention component involves initiating word-finding trials with a complex left-hand movement. The study addresses (1) whether or not the intention manipulation (complex left-hand movement) makes a unique contribution to treatment outcome and (2) whether or not the intention manipulation helps to shift word production mechanisms from the left to the right frontal lobe. All study participants take part in functional magnetic resonance imaging (fMRI) scans of word-finding before and after treatment and at 3-month follow-up to measure changes in lateralization of frontal lobe activity during word finding. Only patients with a substantial degree of left frontal activity on the pre-treatment fMRI scan can participate. There are three specific aims: (1) to determine if repetitive initiation of word production with a complex left-hand movement leads to increased right-hemisphere lateralization of frontal activity and if these changes can be attributed to the intention component of treatment, (2) to determine whether activity in posterior perisylvian cortices that is entrained to right frontal activity shows a greater increase in right-hemisphere lateralization from pre- to post-treatment fMRI when the intention component is included in treatment, and (3) to determine whether onset of hemodynamic responses (HDRs) in right motor/premotor cortex becomes more closely associated with the temporal onset of participants' spoken responses across treatment when the intention component is included in treatment. If successful, the treatment can provide a new treatment vehicle for increasing language function in patients with "nonfluent" aphasia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
21 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Nonfluent aphasia caused by stroke
  • Moderate to severe word-finding problems
  • 6 or more months post stroke
  • Right handed prior to stroke
  • All strokes in left hemisphere
  • Native English speaker
  • Capable of following verbal directions

排除标准

  • Severe impairment of word comprehension
  • Brain injury or disease in addition to stroke
  • Drug or alcohol abuse within past 6 months
  • Schizophrenia or other psychiatric disorder necessitating hospitalization
  • History of learning disability
  • Claustrophobia
  • Cardiac pace-maker
  • Ferrous metal implants not attached to bone, metal fragments in body
  • Profound hearing loss

结局指标

主要结局

Lateralization of Frontal Lobe (and Posterior Perisylvian) Activity During Word Production

时间窗: immediately post-treatment scan minus pre-treatment baseline scan

Functional MRI laterality indices (LIs)were calculated for lateral frontal, medial frontal, and posterior perisylvian cortex regions of interest (ROIs): L=number of active voxels in left hemisphere ROI and R=number of active voxels in right hemisphere ROI using the following formula: (L-R)/(L+R). LIs could vary from -1 (completely right lateralized) to +1 (completely left lateralized). Then, change in LIs was calculated by subtracting the pre-treatment from the post-treatment and 3-mo follow-up LI. It was expected the intention manipulation would show a rightward shift in LI.

次要结局

  • Picture Naming Probe Scores (% Accuracy)(trend for time series of 8 baseline + 30 treatment sessions)
  • Category Member Generation Probe Scores (% Accuracy)(trend for time series of 8 baseline + 30 treatment sessions)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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