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临床试验/NCT06842745
NCT06842745招募中2 期

Personalized Transcranial Magnetic Stimulation and Constraint Induced Language Therapy to Treat Mild Post-Stroke Aphasia

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年2月11日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
招募中
入组人数
24
试验地点
1
主要终点
Sentence Processing

研究概览

简要总结

The goal of this clinical trial is to determine if Transcranial Magnetic Stimulation (TMS) combined with Speech-Language Therapy (SLT) is an effective treatment for mild aphasia in persons with chronic stroke.

The main questions this study aims to answer are:

  1. Can TMS combined with SLT improve conversational speech and comprehension?
  2. Can we identify specific behavioral and biological characteristics that would benefit most from the TMS and SLT treatment?

Researchers will compare real TMS to sham (fake) TMS to see whether TMS can treat post-stroke mild aphasia.

Participants will:

  • Complete a screening and medical intake to determine eligibility
  • Undergo a MRI
  • Participate in 10 consecutive sessions (Monday-Friday) of TMS and SLT treatment
  • Complete follow-up assessments 2 and 4 months after treatment

详细描述

Aphasia is an acquired disorder of language that occurs in approximately 30% of individuals with stroke and impacts approximately 1 million Americans (see NINDS.NIH.gov). Current treatments for aphasia are only modestly beneficial, so there is a clear need for more efficacious therapy.

Previous research has demonstrated that TMS improves language performance in persons with aphasia and the benefit has been shown to be sustained. All studies of which we are aware, however, have included participants with moderate/severe aphasia. The issue of mild aphasia has received little attention to date but as there is an increasing recognition that even very mild language deficits have important negative consequences for employment and social well-being. This study will aim to treat mild aphasia with TMS and SLT emphasizing conversations speech.

One limitation of TMS has been variability in response; TMS has shown good within-subject reliability but more substantial variability between subjects. In recognition of these issues, "electrical field" (e-field) models have been developed to account for these individual differences in anatomy. We will the utilize e-field models in conjunction with an individually determined resting motor threshold to generate a personalized treatment regimen that is likely to ensure that all subjects receive the same TMS intensity relative to their individual motor threshold and greatly reduces the possibility of under- or over-dosing with respect to TMS intensity. We will employ continuous theta-burst stimulation, 600 brief electrical pulses delivered in 40 seconds, over the right front part of the brain (pars triangularis).

Participants who are enrolled can expect to undergo a battery of tests to define their language function as well as a research MRI scan that will be used to guide TMS therapy and to assess the size and location of the stroke and its impact on brain pathways. After baseline testing, subjects will undergo treatment using TMS (or sham) + SLT for 10 sessions (Monday-Friday) over the course of 2 consecutives week. Follow-up assessment of language functioning will be assessed immediately, 2 months and 4 months after treatment.

Participants will be compensated for their time and travel.

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, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Left Hemisphere stroke
  • •Stroke occurred more than 6 months ago
  • •Mild Aphasia (WAB AQ score > 85)
  • •Proficient in English

排除标准

  • •Ongoing substance or alcohol abuse
  • •Other neurological disorders, beside stroke (i.e. dementia, traumatic brain injury, multiple sclerosis)
  • •Active psychiatric disorders (i.e. bipolar disorder, schizophrenia)
  • •Pacemaker or cardiac defibrillator
  • •Diagnosis of tinnitus
  • •Epilepsy, or seizure in the past 6 months

研究组 & 干预措施

Real TMS

Experimental

Some of our participants will be randomized to the real treatment arm where they will receive 10 sessions of real TMS paired with speech-language therapy.

干预措施: Transcranial Magnetic Stimulation (TMS) (Device)

Real TMS

Experimental

Some of our participants will be randomized to the real treatment arm where they will receive 10 sessions of real TMS paired with speech-language therapy.

干预措施: Speech-Language Therapy (SLT) (Behavioral)

Fake TMS

Sham Comparator

Some of our participants will be randomized to the sham treatment arm where they will receive 10 sessions of fake TMS paired with speech-language therapy.

干预措施: Speech-Language Therapy (SLT) (Behavioral)

结局指标

主要结局

Sentence Processing

时间窗: From baseline to 4 months post-intervention

Change in performance on the Temple Assessment of Language and Short-term Memory in Aphasia (TALSA) sentence processing composite score.

次要结局

  • Semantic and Phonological Processing(From baseline to 4 months post-intervention)
  • Elicited Speech(From baseline to 4 months post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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