跳至主要内容
临床试验/NCT05093673
NCT05093673招募中不适用

Cerebellar Stimulation for Aphasia Rehabilitation

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年10月25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
60
试验地点
1
主要终点
Change in accuracy of naming untrained pictures (Philadelphia Naming Test)

研究概览

简要总结

The optimal site of neuromodulation for post-stroke aphasia has yet to be established. This study will investigate whether multiple sessions of cerebellar transcranial direct current stimulation (tDCS) boosts language therapy in helping people recover from aphasia as well as predict who is likely to respond to cerebellar tDCS.

详细描述

Aphasia is a devastating complication of stroke. Speech and language treatment (SLT) can be helpful in restoring language function, but not all individuals show improvement. Recent studies indicate that Transcranial Direct Current Stimulation (tDCS) is a promising adjuvant approach to enhance the effectiveness of SLT. tDCS is a noninvasive, non-painful, electrical stimulation of the brain. It is believed that tDCS boosts neural plasticity that underlies recovery with SLT. A majority of the tDCS studies of aphasia have stimulated the left hemisphere regions. However, left hemisphere lesions common in post-stroke aphasia affect the electrical field in unpredictable ways, potentially preventing stimulation from reaching perilesional tissue associated with optimal recovery. The investigators' prior work addressed this problem by stimulating a novel region, the right cerebellum. The right cerebellum is connected to the left hemisphere and involved in a variety of cognitive and language functions, including naming, which is often impaired in people with aphasia. The investigators' work has shown that cerebellar tDCS is safe, easily tolerated, and improved language skills in a number of stroke participants with aphasia. The proposed project will build on these findings by conducting a randomized, double-blind, sham-controlled, trial to determine the effectiveness of cathodal tDCS to the right cerebellum for the treatment of post-stroke aphasia. The investigators will test the hypothesis that 15 sessions of cerebellar tDCS combined with an evidenced-based anomia treatment (semantic feature analysis, SFA) is associated with greater gains in accuracy in naming pictures, compared to 15 sessions of sham combined with semantic feature analysis

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic ischemic or hemorrhagic left hemisphere stroke
  • Fluent speaker of English by self-report
  • Age 18 or older
  • 6 months post onset of stroke
  • Diagnosis of aphasia and naming impairment using the Western Aphasia Battery-Revised

排除标准

  • Lesion in the right cerebellum
  • Previous neurological disorder (other than stroke) affecting the brain, or any other neurodegenerative disorder or psychiatric disorder
  • Seizures during the previous 6 months
  • Uncorrected visual loss or hearing loss by self-report
  • Use of medications that lower the seizure threshold (e.g., methylphenidate)
  • Use of N-methyl-D-aspartate (NMDA) antagonists (e.g., memantine)
  • History of brain surgery or any metal in the head
  • Severely impaired auditory comprehension (lower than 2 on the Comprehension subscore on the Western Aphasia Battery-Revised)
  • Severely limited verbal output (lower than 2 on the Spontaneous Speech rating scale on the Western Aphasia Battery-Revised)
  • Individuals with severe claustrophobia, cardiac pacemakers or ferromagnetic implants, and pregnant women will be excluded from the MRI portion of the study.

研究组 & 干预措施

Cathodal Cerebellar tDCS and SFA

Active Comparator

Cathodal cerebellar tDCS, 2 milliamp (mA) plus Semantic Feature Analysis (SFA) naming treatment for 15 sessions (25-minutes per each 60-minute treatment session) over the course of 3-5 weeks. The electrical current will be administered to the right cerebellum. The stimulation will be delivered at an intensity of 2 mA for a maximum of 25 minutes. SFA will be delivered by a Speech and Language Pathologist to improve naming

干预措施: Cathodal Cerebellar tDCS (Device)

Cathodal Cerebellar tDCS and SFA

Active Comparator

Cathodal cerebellar tDCS, 2 milliamp (mA) plus Semantic Feature Analysis (SFA) naming treatment for 15 sessions (25-minutes per each 60-minute treatment session) over the course of 3-5 weeks. The electrical current will be administered to the right cerebellum. The stimulation will be delivered at an intensity of 2 mA for a maximum of 25 minutes. SFA will be delivered by a Speech and Language Pathologist to improve naming

干预措施: Semantic Feature Analysis (SFA) (Behavioral)

Sham Cerebellar tDCS and SFA

Sham Comparator

Sham cerebellar tDCS plus SFA for 15 sessions (25-minutes per each 60-minute treatment session) over the course of 3-5 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SFA will be delivered by a Speech and Language Pathologist to improve naming.

干预措施: Semantic Feature Analysis (SFA) (Behavioral)

Sham Cerebellar tDCS and SFA

Sham Comparator

Sham cerebellar tDCS plus SFA for 15 sessions (25-minutes per each 60-minute treatment session) over the course of 3-5 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SFA will be delivered by a Speech and Language Pathologist to improve naming.

干预措施: Sham (Device)

结局指标

主要结局

Change in accuracy of naming untrained pictures (Philadelphia Naming Test)

时间窗: Pre-treatment to one week after the end of SFA treatment

Behavioral measure of change in untrained naming. Scores ranges from 0 to 175 with higher scores meaning better naming ability.

次要结局

  • Change in the total content units produced during picture description.(Pre-treatment, 1 week, 1, 3, and 6 months post treatment)
  • Change in the syllable per content units produced during picture description.(Pre-treatment, 1 week, 1, 3, and 6 months post treatment)
  • Change in accuracy of naming untrained pictures (Philadelphia Naming Test)(Pre-treatment and at 1, 3 and 6 months post treatment)
  • Change in accuracy of naming trained pictures(Pre-treatment and at 1, 3 and 6 months post treatment)
  • Change in functional communication skills(Pre-treatment, 1 week, 1, 3, and 6 months post treatment)
  • Change in Stroke and Aphasia Quality of Life (SAQOL) scale(Pre-treatment, 1 week, 1, 3, and 6 months post treatment)
  • Change in General Health Questionnaire-12 item (GHQ-12)(Pre-treatment, 1 week, 1, 3, and 6 months post treatment)
  • Change in accuracy of naming trained pictures(Pre-treatment to one week after the end of SFA treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验