跳至主要内容
临床试验/NCT04883229
NCT04883229撤回不适用

tDCS and Speech Therapy for Motor Speech Disorders Caused by FTLD Syndromes: a Feasibility Study

University of California, San Francisco0 个研究点开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Change in speech intelligibility

研究概览

简要总结

The investigators will test the feasibility of using transcranial direct current stimulation (tDCS) and speech therapy to treat participants with motor speech disorders caused by Frontotemporal Lobar Degeneration Pathology including nonfluent variant Primary Progressive Aphasia, Progressive Supranuclear Palsy, Corticobasal Syndrome, or behavioral variant Frontotemporal Dementia.

The investigators will deliver transcranial direct current stimulation (tDCS) either in a clinic setting at the University of California San Francisco, or in patients' homes, via a consumer tDCS device and videoconferencing. Transcranial direct current stimulation (tDCS) is a neuromodulation technique that can enhance the benefits of speech therapy treatment. Participants will receive a dose of tDCS stimulation + speech therapy and a dose of sham tDCS + speech therapy in a randomized double blind crossover study performed either in the clinic or at home via videoconferencing. This study can be performed entirely remotely.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Device Feasibility
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mini Mental Status Exam score > 10
  • diagnosis of nfvPPA via Gorno-Tempini 2011 criteria, or a diagnosis of FTLD syndrome including progressive supranuclear palsy, corticobasal syndrome or behavioral variant frontotemporal dementia PLUS a motor speech disorder (apraxia of speech and/or dysarthria)
  • able to give consent
  • right-handed
  • native English speaker
  • having a caregiver who is also able to sign and understand the caregiver's consent form.

排除标准

  • History of:
  • brain cancer
  • craniotomy, skull surgery or fracture
  • metallic implant in head
  • pacemaker or cardioverter-defibrillator
  • pregnancy.

结局指标

主要结局

Change in speech intelligibility

时间窗: baseline and three months post treatment

Percent intelligible words, calculated by an SLP scoring each word spoken as intelligible or unintelligible, divided by total number of words spoken, during trained and untrained scripted speech.

次要结局

  • Feasibility of remote use of device(Immediately after the second block of treatment)

研究者

申办方类型
Other
责任方
Sponsor

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