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Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke (PART-CN)

2026年10月27日 更新者：Johns Hopkins University

Predicting Aphasia Recovery and Testing Cerebellar Neuromodulation (PART-CN): A Pilot Wait-List Randomized Trial of Cathodal Cerebellar Transcranial Direct Current Stimulation Plus Computerized Language Therapy in Stroke Survivors Predicted to Have Poor Language Recovery

This pilot study tests whether a mild form of brain stimulation to the cerebellum, combined with computer-based language therapy, helps people recover language after a stroke when a poor natural recovery is predicted.

People already taking part in a Johns Hopkins study of stroke and language recovery, whose early data suggest the aphasia is unlikely to resolve without treatment, are invited about 3 months after the stroke. Half begin 15 treatment sessions right away and half begin about 3 months later. Each session pairs 25 minutes of transcranial direct current stimulation (tDCS) over the right cerebellum with 45 to 60 minutes of language exercises, with a speech-language pathologist present.

The main question is whether language ability, measured with the Western Aphasia Battery-Revised Aphasia Quotient, improves more by 6 months after stroke in the group treated first than in the group still waiting. The study also checks how accurately a machine learning model, built from data collected in the first days after stroke, predicted each person's language ability 12 months after stroke.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

About one third of people with aphasia after stroke respond poorly to language therapy, and current clinical tools cannot identify these individuals early, when recovery is steepest. This study pairs a recovery prediction model with a targeted treatment.

Aim 1: A machine learning model trained on acute-phase data from the parent longitudinal study (Johns Hopkins IRB NA_00042097; neuroimaging, cognitive-linguistic testing, demographics) predicts each participant's 12-month Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ). Participants predicted to remain below 93.8 (aphasia not expected to resolve) are eligible. Prediction accuracy is evaluated prospectively against observed 12-month scores (mean absolute error, correlation, and sensitivity, specificity, positive predictive value and F1 for the below-93.8 classification).

Aim 2: Eligible participants are randomized 1:1 to early intervention (treatment beginning about 3 months post-stroke) or wait-list control (usual care until about 6 months post-stroke, then the same treatment). Treatment is 15 sessions, up to 5 per week over about 3 to 5 weeks. In each session, cathodal tDCS (2 mA, 25 minutes; cathode over the right cerebellum, 1 cm below the inion and 4 cm lateral; anode over the right deltoid; Soterix Medical 1×1 device) is delivered during the first 25 minutes of 45 to 60 minutes of computer-delivered language therapy targeting picture naming, auditory comprehension, reading and spelling, with a speech-language pathologist present throughout. Sessions may take place at a Johns Hopkins site or at home with a study team member present.

The primary comparison is change in WAB-R AQ from baseline (about 3 months post-stroke) to 6 months post-stroke between the treated early group and the untreated wait-list group. Secondary measures include naming of trained items, discourse (content units and syllables per content unit in picture description), functional communication (Communication Activities of Daily Living, Third Edition), emotional well-being (General Health Questionnaire), quality of life (Stroke and Aphasia Quality of Life Scale), and resting-state functional connectivity measured with functional near-infrared spectroscopy (fNIRS). Participants are followed to 12 months post-stroke.

As a pilot, the study is designed to show feasibility of the predict-then-intervene approach and to estimate effect sizes for a future fully powered, sham-controlled trial.

研究类型

介入性

注册 (估计的)

8

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Manuel J Marte, PhD, CCC-SLP
  • 电话号码：845-598-6911
  • 邮箱：mmarte1@jh.edu

研究联系人备份

学习地点

  • 美国
    • Maryland
      • Baltimore、Maryland、美国、21287
        • The Johns Hopkins Hospital, Phipps Building
        • 接触：
          • Manuel J Marte, PhD, CCC-SLP
          • 电话号码：845-598-6911
          • 邮箱：mmarte1@jh.edu

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Enrolled in the Johns Hopkins longitudinal stroke and aphasia study (IRB NA_00042097)
  • Consented to future contact for research studies
  • Predicted to have poor language recovery from acute-phase data, defined as a predicted Western Aphasia Battery-Revised Aphasia Quotient below 93.8 at 12 months post-stroke
  • Ischemic left hemisphere stroke
  • Aphasia with naming impairment on the Western Aphasia Battery-Revised
  • Approaching 3 months post-stroke at enrollment
  • Fluent speaker of English by self-report
  • Age 18 or older

Exclusion Criteria:

  • Lesion in the right cerebellum
  • Previous neurological disorder other than stroke affecting the brain, or any neurodegenerative or psychiatric disorder
  • Seizures during the previous 6 months
  • Uncorrected visual or hearing loss by self-report
  • Use of medications that lower the seizure threshold (e.g., methylphenidate)
  • Use of N-methyl-D-aspartate (NMDA) receptor antagonists (e.g., memantine)
  • History of brain surgery or any metal in the head
  • Severely impaired auditory comprehension (below 2 on the Western Aphasia Battery-Revised Auditory Verbal Comprehension sub-score)
  • Severely limited verbal output (below 2 on the Western Aphasia Battery-Revised Spontaneous Speech rating)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Early intervention

15 sessions of cathodal right cerebellar transcranial direct current stimulation (tDCS; 2 mA, 25 minutes) during computerized language therapy (45 to 60 minutes per session, with a speech-language pathologist present), up to 5 sessions per week over about 3 to 5 weeks, beginning about 3 months post-stroke.
设备：Cathodal cerebellar transcranial direct current stimulation

Cathode (saline-soaked sponge electrode) over the right cerebellum, 1 cm below the inion and 4 cm lateral; anode over the right deltoid. Constant current of 2 mA for 25 minutes, ramped up over the first 15 seconds, from a battery-powered Soterix Medical 1x1 stimulator with pre-programmed parameters. Delivered during the first 25 minutes of each language therapy session.

其他名称：
  • 时间点DCS
  • Soterix Medical 1x1 tDCS
行为的：Computerized language therapy

Computer-delivered language exercises on a tablet, targeting spoken and written picture naming, auditory comprehension, reading and spelling, 45 to 60 minutes per session, with difficulty adjusted to performance and a speech-language pathologist present. Each participant uses the same delivery platform for all sessions.

其他名称：
  • Computer-delivered naming treatment
其他：Wait-list control (delayed intervention)

Usual care, which may include outpatient speech-language therapy, from about 3 to 6 months post-stroke; then the same 15-session protocol of cathodal right cerebellar tDCS plus computerized language therapy, beginning about 6 months post-stroke.
设备：Cathodal cerebellar transcranial direct current stimulation

Cathode (saline-soaked sponge electrode) over the right cerebellum, 1 cm below the inion and 4 cm lateral; anode over the right deltoid. Constant current of 2 mA for 25 minutes, ramped up over the first 15 seconds, from a battery-powered Soterix Medical 1x1 stimulator with pre-programmed parameters. Delivered during the first 25 minutes of each language therapy session.

其他名称：
  • 时间点DCS
  • Soterix Medical 1x1 tDCS
行为的：Computerized language therapy

Computer-delivered language exercises on a tablet, targeting spoken and written picture naming, auditory comprehension, reading and spelling, 45 to 60 minutes per session, with difficulty adjusted to performance and a speech-language pathologist present. Each participant uses the same delivery platform for all sessions.

其他名称：
  • Computer-delivered naming treatment

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ)
大体时间：Baseline (approximately 3 months post-stroke) and 6 months post-stroke

The WAB-R AQ is a composite measure of overall language impairment, with scores ranging from 0 to 100; higher scores indicate milder aphasia (better outcome). Change from baseline to 6 months post-stroke is compared between the early intervention group (after treatment) and the wait-list group (before treatment).
Baseline (approximately 3 months post-stroke) and 6 months post-stroke
Mean Absolute Error Between Predicted and Observed 12-Month Western Aphasia Battery-Revised Aphasia Quotient
大体时间：12 months post-stroke

Mean absolute difference, in WAB-R AQ points (scale 0 to 100), between the machine learning model's predicted 12-month Western Aphasia Battery-Revised Aphasia Quotient (generated from acute-phase data) and the observed 12-month score. Lower values indicate more accurate prediction.
12 months post-stroke

次要结果测量

结果测量
措施说明
大体时间
Percentage of Treatment Items Produced Correctly
大体时间：During treatment, up to one week post final treatment session (about 4 to 6 weeks after treatment starts)

Percentage of items trained during treatment that are produced correctly, scored 0 to 100%; higher values indicate better performance.
During treatment, up to one week post final treatment session (about 4 to 6 weeks after treatment starts)
Change in Number of Content Units in Picture Description
大体时间：Baseline (approximately 3 months post-stroke) and 6 months post-stroke

Total number of content units (accurate, relevant pieces of information) produced when describing the Modern Cookie Theft picture and the Precarious Painter picture. Higher values indicate more informative discourse.
Baseline (approximately 3 months post-stroke) and 6 months post-stroke
Change in Syllables per Content Unit in Picture Description
大体时间：Baseline (approximately 3 months post-stroke) and 6 months post-stroke

Number of syllables produced per content unit in the same picture descriptions
Baseline (approximately 3 months post-stroke) and 6 months post-stroke
Change in Communication Activities of Daily Living, Third Edition (CADL-3) Total Score
大体时间：Baseline (approximately 3 months post-stroke) and 6 months post-stroke

The Communication Activities of Daily Living, Third Edition measures everyday functional communication in people with aphasia. Total raw score ranges from 0 to 100; higher scores indicate better functional communication.
Baseline (approximately 3 months post-stroke) and 6 months post-stroke
Change in General Health Questionnaire (GHQ) Total Score
大体时间：Baseline (approximately 3 months post-stroke) and 6 months post-stroke

The General Health Questionnaire (Goldberg and Hillier) measures psychological distress and emotional well-being. Items are rated using 0 to 3 Likert scale, giving a total score from 0 to 84; higher scores indicate greater psychological distress (worse outcome).
Baseline (approximately 3 months post-stroke) and 6 months post-stroke
Change in Stroke and Aphasia Quality of Life Scale (SAQOL-39) Mean Score
大体时间：Baseline (approximately 3 months post-stroke) and 6 months post-stroke

The Stroke and Aphasia Quality of Life Scale-39 measures health-related quality of life after stroke and aphasia. Mean score ranges from 1 to 5; higher scores indicate better quality of life.
Baseline (approximately 3 months post-stroke) and 6 months post-stroke
Change in Resting-State Functional Connectivity Between Cortical Language Regions and the Right Cerebellum
大体时间：Baseline (approximately 3 months post-stroke), 6 months, and 9 months post-stroke

Resting-state functional connectivity (correlation coefficient of oxygenated hemoglobin signals) between cortical language regions and the right cerebellum, measured with functional near-infrared spectroscopy (fNIRS). Higher values indicate stronger connectivity.
Baseline (approximately 3 months post-stroke), 6 months, and 9 months post-stroke

其他结果措施

结果测量
措施说明
大体时间
Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ) at 9 Months Post-Stroke
大体时间：9 months post-stroke

The WAB-R AQ is a composite measure of overall language impairment (range 0 to 100; higher scores indicate milder aphasia). Compared between groups to explore the effect of treatment timing (treatment starting about 3 versus 6 months post-stroke).
9 months post-stroke
Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ) at 12 Months Post-Stroke
大体时间：12 months post-stroke

The WAB-R AQ is a composite measure of overall language impairment (range 0 to 100; higher scores indicate milder aphasia). Used to assess durability of treatment effects in all participants.
12 months post-stroke

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Johns Hopkins University

合作者

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

调查人员

  • 首席研究员：Melissa D Stockbridge, PhD, CCC-SLP、Johns Hopkins University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2028年6月1日

研究完成 (估计的)

2028年6月1日

研究注册日期

首次提交

2026年10月27日

首先提交符合 QC 标准的

2026年10月27日

首次发布 (实际的)

2026年11月3日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年10月27日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IRB00562650
  • 2T32HD007414-31 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be shared outside Johns Hopkins. Data collected in this study are coded protected health information under the approved protocol and consent. Aggregate results will be published.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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