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临床试验/NCT04375722
NCT04375722招募中不适用

Exogenous Tuning of Neural Oscillations as a Mode of Treatment in Post-stroke Aphasia

Medical College of Wisconsin1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
tACS-dependent neurophysiological changes

研究概览

简要总结

This study will assess the effects of transcranial alternating current stimulation (tACS) on language recovery after stroke as well as healthy language functions.

详细描述

Aphasia is a debilitating disorder, typically resulting from damage to the left hemisphere, that can impair a range of communication abilities, including language production and comprehension, reading, and writing. Approximately 180,000 new cases of aphasia are identified per year, and approximately 1 million or 1 in 250 are living with aphasia in the United States (NIH-NIDCD, 2015). Treatments are limited and provide modest benefits at best. The current emphasis in aphasia rehabilitation is to formulate intensive speech and language therapies and augment therapeutic benefits by providing brain stimulation concurrent with therapies.

The current study will investigate the efficacy of high-definition tACS (HD-tACS) to help restore neural oscillatory activity in aphasia. TACS differs from widely used transcranial direct current stimulation (tDCS) in that sinusoidal, alternating currents are delivered rather than constant currents. TACS can manipulate the ongoing oscillatory neuronal activity and potentially increase functional synchronization (or connectivity) between targeted areas. This feature of tACS is quite attractive, given the new body of evidence suggesting that language impairments stem from diminished functional connectivity and disruptions in the language network due to stroke. The selection of tACS frequencies in this study is guided by our preliminary work examining pathological neural oscillations found near stroke-lesioned areas (or perilesional) in aphasia and by the involvement of specific frequencies during a verbal short-term memory task. By exogenously tuning the neural oscillations with tACS, the investigators hope to up-regulate communication across regions within the language network and other connected areas to improve outcomes. If successful, tACS will be a powerful and novel treatment approach with reverberating positive impact on long-term recovery.

The study will employ HD-tACS in a within-subject and sham-controlled design, using frequencies ranging from theta to low-gamma (4-40 Hz) combined with language tasks. Magnetoencephalography (MEG) or electroencephalography (EEG) will be used to determine tACS frequencies and to evaluate behavioral and neurophysiological changes in response to tACS. Investigators plan to recruit 200 participants: 100 stroke survivors with aphasia and 100 healthy controls.

Participants will complete language testing that covers a broad range of language functions, medical history, and MRI. Eligible participants will undergo active tACS or sham-tACS over 3-4 sessions. The tACS administrator and participants will be blinded to the stimulation type. The order of stimulation type will be counterbalanced across participants. Washout period between visits will be at least 48 hours to minimize potential carryover effects. MEG will be collected prior to tACS sessions during a language task to determine tACS frequency. EEG may be acquired before and after tACS during periods of rest (resting-state) and during language tasks. Participants will complete a questionnaire at the end of stimulation visits to assess potential side effects of tACS. Total time enrolled in the study is expected to be 2-3 weeks, which may be longer depending on participant's availability.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Healthy Controls
  • 18 years of age or older
  • Fluent in English
  • No history of neurological or psychiatric disorders
  • Stroke Patients
  • Diagnosed with post-stroke aphasia by referring physician/neuropsychologist
  • Consent date >=1 months after stroke onset
  • Right-handed
  • Fluent in English
  • 18 years of age or older

排除标准

  • Severe cognitive, auditory or visual impairments that would preclude cognitive and language testing
  • Presence of major untreated or unstable psychiatric disease
  • A chronic medical condition that is not treated or is unstable
  • The presence of cardiac stimulators or pacemakers
  • Any metal implants in the skull
  • Contraindications to MRI or tACS
  • History of seizures
  • History of dyslexia or other developmental learning disabilities

结局指标

主要结局

tACS-dependent neurophysiological changes

时间窗: Changes monitored over pre and immediately after 20 minutes of tACS

Concomitant frequency-specific EEG changes in spectral power and phase synchronization are expected.

tACS changes in language performance verbal STM tasks

时间窗: Changes monitored over pre, during and immediately after 20 minutes of tACS

Improvement on verbal STM performance as determined by increases in span, accuracy or decreases in reaction time is expected with active tACS.

次要结局

  • Individual differences in tACS responsiveness(Based on immediate changes monitored after 20 minutes of tACS)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Priyanka Shah-Basak, PhD

Priyanka Shah-Basak, PhD

Medical College of Wisconsin

研究点 (1)

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