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临床试验/NCT06891638
NCT06891638已完成不适用

Enhancing Reading Recovery in Aphasia With tDCS and PMT

Kessler Foundation2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2025年5月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6
试验地点
2
主要终点
Reading aloud accuracy

研究概览

简要总结

This study is designed for individuals with aphasia, a language disorder that affects many stroke survivors, making it difficult to read, speak, and understand language. Up to 70% of people with aphasia struggle with reading, which impacts their ability to communicate, work, and engage in daily life.

The study aims to test a new approach to reading rehabilitation by combining Phono-Motor Treatment (PMT), a language therapy adapted to improve reading, with transcranial direct current stimulation (tDCS), a safe and painless brain stimulation technique. tDCS delivers a mild electrical current to the brain, which may enhance learning. This study will assess whether adding tDCS to PMT improves reading therapy outcomes.

详细描述

This study aims to improve reading rehabilitation for individuals with aphasia, a language disorder that affects many stroke survivors. The goal is to determine whether adding transcranial direct current stimulation (tDCS), a safe and painless brain stimulation technique, to Phono-Motor Treatment (PMT), a language therapy adapted for reading, enhances treatment effectiveness.

Participants will be randomly assigned to one of three treatment groups, each receiving different combinations of PMT and tDCS over six weeks. Some will receive active tDCS at different points in therapy, while others will receive a placebo (sham) version. By comparing how the timing of tDCS affects reading improvement, this study aims to optimize treatment strategies for individuals with aphasia.

Reading and language skills will be assessed before, during, and after treatment using standardized tests to measure progress. The study will take place at two sites: Kessler Foundation and the Medical College of Wisconsin (MCW), where participants will complete therapy sessions.

Findings from this research may help develop more effective and accessible treatments for stroke survivors with aphasia, improving their ability to read and communicate.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Chronic (>6 months) left-hemisphere stroke
  • •Aphasia diagnosis.
  • •Deficits in reading aloud.

排除标准

  • •Eye condition not correctable with lenses and interfering with reading (e.g., blindness)
  • •Severe apraxia of speech or cognitive deficits preventing participation.
  • •Participation in one-on-one aphasia rehabilitation during the study period.
  • •Brain disorders other than stroke (such as Alzheimer's Disease or Dementia, Parkinson's Disease, etc)
  • •Contraindications of tDCS or MRI
  • •Skin condition affecting the scull (e.g., psoriasis) or open wounds at the stimulation site.
  • •Presence of metallic implants (e.g., cardiac stimulators or pacemakers, cochlear implants)
  • •History of ongoing/unmanaged seizers
  • •Pregnancy
  • •Claustrophobia
  • •Inability to lie flat on the back

研究组 & 干预措施

Early tDCS

Experimental

This group will undergo Active tDCS + PMT for weeks 1-3 and Sham tDCS + PMT for weeks 4-6.

干预措施: Schedule of tDCS administration (Device)

Late tDCS

Sham Comparator

This group will undergo Sham tDCS + PMT for weeks 1-3 and Active tDCS + PMT for weeks 4-6.

干预措施: Schedule of tDCS administration (Device)

Interleaved tDCS

Active Comparator

This group will receive PMT + Active/Sham tDCS on alternate days for 6 weeks.

干预措施: Schedule of tDCS administration (Device)

结局指标

主要结局

Reading aloud accuracy

时间窗: before treatment, midway through treatment, and immediately after treatment

Participants will read words and pronounceable pseudowords that appear one at a time on the computer screen. Each testing session will be audio recorded and independently scored by 2 raters, with ties resolved by a 3rd rater.

次要结局

  • Reading Comprehension Battery for Aphasia 2nd Edition(before treatment, midway through treatment, and immediately after treatment)
  • Western Aphasia Battery(before treatment, midway through treatment, and immediately after treatment)

研究者

发起方
Kessler Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Olga Boukrina

Assistant Director, Center for Stroke Rehabilitation Research

Kessler Foundation

研究点 (2)

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