Electrical Field Guided Transcranial Magnetic Stimulation to Treat Subacute Post-stroke Aphasia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Overall language function
研究概览
简要总结
The goal of this clinical trial is to determine if Transcranial Magnetic Stimulation (TMS) combined with modified Constraint Induced Language Therapy (mCILT) is an effective treatment for aphasia when delivered in the subacute stage after stroke.
The main questions this study aims to answer are:
- Can TMS combined with mCILT improve overall speech?
- Can we identify specific behavioral and biological characteristics that would benefit most from the TMS and mCILT treatment?
Researchers will compare real TMS to sham (fake) TMS to see whether TMS can treat subacute aphasia.
Importantly, this trial will use electric field guided TMS to identify optimal and individualized stimulation intensity and site targeting.
Participants will:
- Complete a screening and medical intake to determine eligibility
- Undergo MRI scans
- Participate in 10 consecutive sessions (Monday-Friday) of TMS and mCILT treatment
- Complete follow-up assessments immediately and 4 months after treatment
详细描述
Aphasia is an acquired disorder of language that occurs in approximately 30% of individuals with stroke and impacts approximately 1 million Americans (see NINDS.NIH.gov). Current treatments for aphasia are only modestly beneficial, so there is a clear need for more efficacious therapy.
Most studies of TMS as a therapy for aphasia have investigated treatment in the chronic phase after stroke (>6 months post-stroke). Previous research has demonstrated that TMS improves language performance in persons with chronic aphasia and the benefit has been shown to be sustained. Several lines of evidence, however, suggest that TMS treatment in the subacute period may be more effective than interventions in the chronic stage.
One limitation of TMS has been variability in response; TMS has shown good within-subject reliability but more substantial variability between subjects. In recognition of these issues, "electrical field" (e-field) models have been developed to account for these individual differences in anatomy. We will the utilize e-field models in conjunction with an individually determined resting motor threshold to generate a personalized treatment regimen that is likely to ensure that all subjects receive the same TMS intensity relative to their individual motor threshold and greatly reduces the possibility of under- or over-dosing with respect to TMS intensity. We will employ continuous theta-burst stimulation, 600 brief electrical pulses delivered in 40 seconds, over the right front part of the brain (pars triangularis).
Participants who are enrolled can expect to undergo a battery of tests to define their language function as well as a research MRI scan that will be used to guide TMS therapy and to assess the size and location of the stroke and its impact on brain pathways. After baseline testing, subjects will undergo treatment using TMS (or sham) + mCILT for 10 sessions (Monday-Friday) over the course of 2 consecutives week. Follow-up assessment of language functioning will be assessed immediately and 4 months after treatment.
Participants will be compensated for their time and travel.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Left hemisphere stroke resulting in aphasia
- •The stroke must have occurred between 2 and 6 weeks prior to enrollment
- •Must be able to understand the nature of the study, and give informed consent
- •English proficiency
- •Right-handed
排除标准
- •History of serious and/or ongoing issues with substance abuse
- •Previous head trauma with loss of consciousness for more than 5 minutes
- •History of major psychiatric illness
- •Dementia, or other neurological conditions
- •Epilepsy, or seizure after the stroke event
- •Pacemaker
- •Diagnosis of tinnitus
- •Pregnancy
研究组 & 干预措施
Real TMS
Some of our participants will be randomized to the real treatment arm where they will receive 10 sessions of real TMS paired with language therapy.
干预措施: Transcranial Magnetic Stimulation (TMS) (Device)
Real TMS
Some of our participants will be randomized to the real treatment arm where they will receive 10 sessions of real TMS paired with language therapy.
干预措施: Modified Constraint Induced Language Therapy (mCILT) (Behavioral)
Fake TMS
Some of our participants will be randomized to the sham treatment arm where they will receive 10 sessions of fake TMS paired with language therapy.
干预措施: Modified Constraint Induced Language Therapy (mCILT) (Behavioral)
结局指标
主要结局
Overall language function
时间窗: From Baseline to 4 months post-interventions
Change in performance on the Western Aphasia Battery (WAB-AQ score). WAB AQ Score is out of 100, where a higher score means less language impairment.
次要结局
未报告次要终点