A Randomized Clinical Trial of tDCS to Remediate Phonological Impairment in Aphasia

Medical College of Wisconsin1 个研究点分布在 1 个国家目标入组 200 人2023年10月3日

适应症Aphasia Stroke

干预措施Speech Therapy Targeted Transcranial Direct Current Stimulation

概览

阶段: 不适用
干预措施: Speech Therapy
疾病 / 适应症: Aphasia
发起方: Medical College of Wisconsin
入组人数: 200
试验地点: 1
主要终点: Behavioral outcome
状态: 进行中（未招募）
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This study will investigate the effects of mild electrical stimulation in conjunction with speech therapy for people with post-stroke aphasia to enhance language recovery.

详细描述

Aphasia is a disturbance of language, primarily caused by brain injury to the left cerebral hemisphere. Aphasia treatments include speech and language therapy and pharmacologic therapy, but several studies have found that these treatments are not completely effective for patients with aphasia, leaving them with residual deficits that significantly add to the cost of stroke-related care. Additionally, the amount and frequency of speech and language therapy delivered may have a critical effect on recovery. Therefore, there is a need for new treatments or adjuncts to existing treatments, such as brain stimulation interventions, that have the potential to show greater improvements in patients with aphasia. One such new approach for non-invasive brain stimulation is transcranial direct current stimulation (tDCS). This study will examine the effects of tDCS during speech therapy to further examine which method or methods is best for patient recovery. Patients enrolled in the study will undergo language testing that covers a broad range of language functions. Functional Magnetic Resonance Imaging (fMRI) will be completed before and after speech therapy intervention arms to investigate the neural processes affected by tDCS and speech therapy. Study design: Patients will be randomly assigned to one of 2 speech therapy groups as well as randomly assigned to one of 2 stimulation groups (active anodal stimulation or sham). Patients will receive one of two different speech therapy treatment interventions to focus on specific processing deficits. Participants will undergo neuropsychological evaluation and fMRI assessment before receiving targeted anodal-tDCS or sham-tDCS for 10 therapy sessions. Participants will then be re-tested using the behavioral assessment measure and fMRI before crossing over to receive the tDCS intervention again, along with the same speech therapy arm. They will complete a behavioral assessment and fMRI at 3 months post Treatment 2 and a final behavioral assessment at 6 months post Treatment 2.

注册库

clinicaltrials.gov

开始日期

2023年10月3日

结束日期

2033年1月1日

最后更新

上个月

研究类型

Interventional

研究设计

Crossover

性别

All

研究者

发起方

Medical College of Wisconsin

责任方

Principal Investigator

主要研究者

Priyanka Shah-Basak, PhD

Assistant Professor

Medical College of Wisconsin

入排标准

入选标准

•Patients must be 18 or older.
•Patients may not be older than
•Patients must have a language deficit from left-sided focal neurologic damage (e.g. stroke, tumor).
•Patients must be adults and have English-language fluency.
•Patients must be eligible to undergo MRI.
•Beyond meeting the inclusion criteria, no preference will be given on the basis of race, ethnicity or gender.

排除标准

•Advanced neurodegenerative disease (i.e. Stage 3 Alzheimer's disease)
•Neurologic disease (e.g. idiopathic epilepsy, seizure disorders that are not well managed, Parkinson's disease, ALS),
•Severe psychopathology (e.g. schizophrenia, bipolar disorder, acute major depressive episode)
•Suspected or diagnosed uncorrectable hearing or vision difficulties, or developmental disabilities (i.e. intellectual disability or learning disability).
•Contraindications to MRI such as claustrophobia, implanted electronic devices, MRI-incompatible metal in the body, extreme obesity, pregnancy, inability to lie flat, inability to see or hear stimulus materials.
•Younger than 18 or older than
•\< 6 months post tumor resection.