跳至主要内容
临床试验/NCT06048159
NCT06048159招募中不适用

TACS for the Recovery of Phonological STM After Stroke

Medical College of Wisconsin2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年11月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
2
主要终点
Accuracy on a phonological STM task

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.

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. 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, potentially with 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 stroke survivors with aphasia. TACS differs from trancranial direct current stimulation (tDCS), a widely used brain stimulation paradigm, in that sinusoidal or alternating currents are delivered rather than direct currents. TACS is shown to manipulate ongoing oscillatory brain activity and also to modulate synchronization (or connectivity) between targeted brain areas. This feature of tACS is quite attractive, given the new body of evidence suggesting that language impairments stem from diminished brain connectivity and ensuing disruptions in the language network due to stroke.

The study will employ high-definition tACS (HD-tACS) in a parallel, double-blinded, sham-controlled design combined with language therapy targeting phonological short-term memory (STM) function in stroke survivors with aphasia. Magnetoencephalography (MEG) and fMRI BOLD data collection will occur to determine tACS parameters and to evaluate stimulation-induced neural changes, respectively. The investigators plan to recruit 120 stroke survivors with aphasia in a 2-group tACS study design.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with left hemisphere stroke/aphasia
  • Consent date >= 1 month after stroke onset
  • 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
  • Contraindications to MRI or tACS, e.g. patients with metallic implants, and/or history of skull fractures, pregnancy, skin diseases
  • History of ongoing or unmanaged seizures
  • History of dyslexia or other developmental learning disabilities

研究组 & 干预措施

High Definition tACS with Short-term Memory Focused Speech Therapy

Experimental

High-Definition-tACS will be delivered via a battery operated alternating current stimulator (Soterix) using two 3x1 center-surround montages.The current is turned on and increased in a ramplike fashion over approximately 30 seconds. Participants will undergo tACS stimulation for 20-minutes with 2 milliampere (mA) peak-to-peak intensity. Stimulation will be maintained no longer than 20 minutes. This will be paired with short-term memory focused speech therapy.

干预措施: HD-tACS (Device)

Sham-High Definition tACS with Short-term Memory Focused Speech Therapy

Sham Comparator

High-Definition-tACS will be delivered via a battery operated alternating current stimulator (Soterix) using two 3x1 center-surround montages. The current is turned on and increased in a ramplike fashion for 10 to 30 seconds and then ramped down. In this way, the participants experience the same initial sensations (mild tingling) as the active tACS groups. This will be paired with short-term memory focused speech therapy.

干预措施: Sham HD-tACS (Device)

结局指标

主要结局

Accuracy on a phonological STM task

时间窗: Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post

Accuracy changes in a delayed sample-to-match task assessing phonological STM after tACS.

fMRI measures of language network activation after tACS

时间窗: Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post

Activation in the language network regions involved in phonological STM will be assessed before and after tACS

次要结局

  • Functional Communication Outcome(Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post)

研究者

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

Priyanka Shah-Basak, PhD

Principal Investigator

Medical College of Wisconsin

研究点 (2)

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