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临床试验/NCT05502822
NCT05502822Unknown不适用

High Definition Transcranial Alternating Current Stimulation (HD-tACS) for Post-stroke Aphasia

Anhui Medical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年3月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
resting-state functional connectivity

研究概览

简要总结

To investigate the intervention effect of high definition transcranial alternating current stimulation(HD-tACS) in chronic post-stroke aphasia and its underlying neural mechanism by MRI.

详细描述

Aphasia is one of the most frequent cognitive deficits in poststroke survivor. More than 20% of stroke patients suffered from language impairment. The recovery of language dysfunction after stroke is highly variable. Some patients recover spontaneously in the early phases of stroke, but about two thirds of patients never fully restore language ability. The purpose of this study was to explore the intervention effect of high definition transcranial alternating current stimulation in chronic post-stroke aphasia.

40 patients with language disorder diagnosed by the Aphasia Battery of Chinese (ABC) were recruited from the first affiliated Hospital of Anhui Medical University. All participants underwent a structured interview and routine laboratory examination before and after receiving HD-tACS. After meeting the inclusion criteria and obtaining informed consent, each participant will complete the clinical evaluation, functional magnetic resonance imaging (fMRI) and HD-tACS treatment conducted by trained researchers at the Neuropsychological Synergetic Innovation Center of Anhui Medical University.

All the participants were randomized (1:1) to receive "real" or "sham" treatment protocol. Stimulation electrodes were arranged in a 4 × 1 ring configuration at F1, F2, C1 ,C2 and FCz, with the central one delivering an alternating current 2 mA and the surrounding 4 electrodes delivering one-fourth of the central electrode's current in the opposite polarity. The average peak-to-peak stimulation intensity across participants was 2 mA for the 6-Hz tACS. In the sham condition, 6-Hz tACS was delivered only during the ramp-up and ramp-down periods (30 s); no current was delivered during the 30-minute intervention. The tACS stimulation lasted 30 minutes, a duration that is common in cognitive neuroscience research. During the tACS, participants sat comfortably in front of a screen, training the speech and comprehension functions to follow a speech therapist.

Before and after the HD-tACS treatment, the patients had receiving a battery measure of neuropsychological tests and Magnetic resonance imaging scan in multimodalities. Neuropsychological assessment included ABC, VFT, Token, MMSE, MoCA, HAMD, HAMA, ADL. Multimodal fMRI includes 3D-T1, rs-fMRI, DTI and ASL.

Neuropsychological evaluation and magnetic resonance imaging data were obtained again 24 hours after the last treatment. The symptoms of the patients were followed up one month after the end of treatment.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aphasia diagnosed by the ABC.
  • 18-75 years old.
  • native Chinese speaker.
  • right-handed.
  • post onset of stroke ≥6months.

排除标准

  • mental illness .
  • severe dysarthria.
  • a history of head injury or surgery.
  • alcohol or substance abuse.
  • cerebral tumor or abscess.

研究组 & 干预措施

sham stimulation

Sham Comparator

In the sham condition, 6-Hz tACS was delivered only during the ramp-up and ramp-down periods (30 s); no current was delivered during the 30-minute intervention. Participants will receive sham tDCS once daily for two weeks.

干预措施: sham high definition transcranial alternating current stimulation (Device)

real stimulation

Active Comparator

Stimulation electrodes were arranged in a 4 × 1 ring configuration at F1, F2, C1 ,C2 and FCz, with the central one delivering an alternating current 2 mA and the surrounding 4 electrodes delivering one-fourth of the central electrode's current in the opposite polarity. The average peak-to-peak stimulation intensity across participants was 2 mA for the 6-Hz tACS. Participants will receive real tACS once daily for two weeks.

干预措施: High definition transcranial alternating current stimulation (Device)

结局指标

主要结局

resting-state functional connectivity

时间窗: baseline and immediately after intervention

the change of resting-state functional connectivity strength between stimulated target and the whole brain areas will be measured by functional MRI.

language function

时间窗: baseline and immediately after intervention

Language deficit was assessed by the same professional language therapist using the Aphasia Battery of Chinese (ABC). The multidimensional test contains four subtypes, including spontaneous speech (semi-standardized interview, assessment of the fluency, and information of speech; total score 20 points), auditory comprehension (yes or no question, auditory picture matching task, and verbal instruction; total score 230 points), repetition (words and sentences; total score 100 points), and naming (simple objects, colors, pictures, and situations; total score 80 points). The combined score is used to calculate an aphasia quotient (AQ) reflecting the overall severity of language impairment. Patients with AQ below 93.8 points were considered as aphasic.

次要结局

  • MMSE(Mini Mental State Examination)(baseline and immediately after intervention)
  • comprehension function(baseline and immediately after intervention)

研究者

发起方
Anhui Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

WANG KAI

Director of medical psychological department, Anhui Medical University

Anhui Medical University

研究点 (1)

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