跳至主要内容
临床试验/NCT03119402
NCT03119402Unknown不适用

Combining A Rhythmic Intervention With tDCS to Improve Reading Skills in Dyslexic Adults

Catholic University of the Sacred Heart2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年4月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Text reading speed expressed in syllables per seconds

研究概览

简要总结

The purpose of the study is to evaluate the effectiveness of the combination of Rhythmic Reading Training (RRT), a computer-assisted intervention method that combines sublexical reading exercises with rhythm processing, and transcranial direct current stimulation (tDCS) on reading abilities of a group of Italian undergraduate students with dyslexia. Two experimental conditions (active vs. sham) will be compared. Finally, the effects of the intervention on other cognitive functions involved in the process of reading (i.e., rapid automatized naming, verbal working memory, rhythm perception abilities) will be measured.

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
Single (Participant)

盲法说明

Participants are prevented from having knowledge of which experimental condition (active or sham tDCS) they are assigned to.

入排标准

年龄范围
19 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • having been diagnosed with DD (ICD-10 code: F81.0) on the basis of standard inclusion and exclusion criteria (ICD-10: World Health Organization, 1992) and of the diagnosis procedure followed in the Italian practice

排除标准

  • presence of comorbidity with other neuropsychiatric or psychopathological conditions (whereas comorbidity with other learning disabilities were allowed)
  • exclusion criteria for the use of tDCS (e.g. epilepsy, pregnancy).

研究组 & 干预措施

RRT + active tDCS

Experimental

Rhythmic Reading Training, administered for 5 hours over 10 days consecutive (30-minute training sessions per day) + simultaneous 20 minutes of active tDCS (1.5 mA, 5x5cm anodal electrode on left parieto-temporal regions and 5x5cm cathodal electrode on right parieto-temporal regions).

干预措施: Rhythmic Reading Training (Behavioral)

RRT + active tDCS

Experimental

Rhythmic Reading Training, administered for 5 hours over 10 days consecutive (30-minute training sessions per day) + simultaneous 20 minutes of active tDCS (1.5 mA, 5x5cm anodal electrode on left parieto-temporal regions and 5x5cm cathodal electrode on right parieto-temporal regions).

干预措施: Transcranial direct current stimulation (Device)

RRT + sham tDCS

Sham Comparator

Rhythmic Reading Training, administered for 5 hours over 10 days consecutive (30-minute training sessions per day) + simultaneous 20 minutes of sham tDCS (with the same active tDCS setup, current applied for 30 seconds,

干预措施: Rhythmic Reading Training (Behavioral)

RRT + sham tDCS

Sham Comparator

Rhythmic Reading Training, administered for 5 hours over 10 days consecutive (30-minute training sessions per day) + simultaneous 20 minutes of sham tDCS (with the same active tDCS setup, current applied for 30 seconds,

干预措施: Transcranial direct current stimulation (Device)

结局指标

主要结局

Text reading speed expressed in syllables per seconds

时间窗: 2 weeks

The ability to read aloud a text was assessed using the Italian standardized test 'Prova di velocità di lettura di brani' (Zoccolotti, Fondazione S. Lucia), which provides speed and accuracy scores in reading aloud age-normed texts.

Text reading accuracy expressed in number of errors

时间窗: 2 weeks

The ability to read aloud a text was assessed using the Italian standardized test 'Prova di velocità di lettura di brani' (Zoccolotti, Fondazione S. Lucia), which provides speed and accuracy scores in reading aloud age-normed texts.

Word reading speed expressed in syllables per seconds

时间窗: 2 weeks

The ability to read aloud lists of words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for word reading (4 lists of 28 words each with different lengths and frequency of use); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for word reading (4 lists of 30 words varying according to length: short vs. long and frequency of use: low vs. high frequency).

Word reading accuracy expressed in number of errors

时间窗: 2 weeks

The ability to read aloud lists of words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for word reading (4 lists of 28 words each with different lengths and frequency of use); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for word reading (4 lists of 30 words varying according to length: short vs. long and frequency of use: low vs. high frequency).

Pseudo-word reading speed expressed in syllables per seconds

时间窗: 2 weeks

The ability to read aloud lists of pseudo-words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for pseudo-word reading (2 lists of 16 pseudo-words each with different lengths); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for pseudo-words reading (2 lists of 30 pseudo-words varying for length: short vs. long).

Pseudo-word reading accuracy expressed in number of errors

时间窗: 2 weeks

The ability to read aloud lists of pseudo-words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for pseudo-word reading (2 lists of 16 pseudo-words each with different lengths); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for pseudo-words reading (2 lists of 30 pseudo-words varying for length: short vs. long).

次要结局

  • Rapid Automatized Naming(2 weeks)
  • Verbal Working Memory(2 weeks)
  • Rhythm Discrimination(2 weeks)

研究者

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

Alice Cancer

Principal Investigator

Catholic University of the Sacred Heart

研究点 (2)

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