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临床试验/NCT04697316
NCT04697316已完成不适用

Transcranial Direct Current Stimulation (tDCS) as a Cognitive Functioning Enhancement Treatment for ADHD Patients Compared to Healthy Controls

Hebrew University of Jerusalem1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2021年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
1
主要终点
Navon task

研究概览

简要总结

This study will examine the possible effects of tDCS (Transcranial Direct Current Stimulation) treatment to the left DLPFC on cognitive functions which were found to be deficient amongst ADHD patients. The study will include 100 subjects, 50 of whom diagnosed with ADHD. Subjects will complete the ASRS questionnaire to measure ADHD symptoms severity. Next, subjects will complete a series of cognitive tasks, after which they will receive either tDCS treatment or a sham treatment. Finally, subjects will repeat the cognitive tasks. Later that day, a telephonic follow up will take place. ADHD symptoms will be assessed again the next day.

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)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participation criteria for healthy participants
  • Right hand dominance.
  • No psychiatric nor neural diagnosis.
  • Participants must be able to comprehend the study's procedure and sign an informed consent.
  • Participation criteria for ADHD diagnosed participants
  • ADHD diagnosis (according to DSM V).
  • Right hand dominance.
  • Participants must be able to comprehend the study's procedure and sign an informed consent.
  • Participants who regularly use Methylphenidate will be required to avoid the medication for 24 hours prior to study and 12 hours post study.

排除标准

  • a. Other psychiatric diagnoses (additional to ADHD). b. Drug use (excluding Methylphenidate). c. Neurological disorders. d. Pacemaker, Insulin pump

研究组 & 干预措施

Healthy control tDCS

Experimental

干预措施: Transcranial Direct Current Stimulation (Device)

Healthy control Sham

Sham Comparator

干预措施: Sham (Device)

ADHD tDCS

Experimental

干预措施: Transcranial Direct Current Stimulation (Device)

ADHD Sham

Sham Comparator

干预措施: Sham (Device)

结局指标

主要结局

Navon task

时间窗: through study completion, up to 1 hour after treatment

change in accuracy, shorter RT's

Stop-signal

时间窗: through study completion, up to 1 hour after treatment

change in response inhibition: shorter SSRT

N-back

时间窗: through study completion

change in working memory: increase in hit rate

Stroop

时间窗: through study completion, up to 1 hour after treatment

change in interference control: smaller interference effect

Time Reproduction task

时间窗: through study completion, up to 1 hour after treatment

change in time perception: increased accuracy

Continuous Performance Task

时间窗: through study completion, up to 1 hour after treatment

change in continuous concentration: increase in accuracy

次要结局

未报告次要终点

研究者

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

Noa Beiman

Principal Investigator

Hebrew University of Jerusalem

研究点 (1)

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