Circuitry Assessment and Reinforcement Training Effects on Recovery (CARTER)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change in Number of Items Correctly Named on the Philadelphia Naming Test
研究概览
简要总结
This study investigates if electroencephalography (EEG) neurofeedback training is more beneficial than sham feedback training for the improvement of communication, anxiety, and sleep quality in individuals with aphasia. Half of the participants will receive active EEG neurofeedback sessions first, followed by sham feedback sessions in a crossover design. The other half of participants will undergo sham feedback sessions first, followed by active neurofeedback.
详细描述
Neurofeedback, a form of biofeedback, provides a visual and/or audio representation of an individual's neural electrical activity from live EEG recording. Using operant conditioning principles, individuals are trained to increase or reduce patterns of brainwave activity to modify behavior and performance. Although neurofeedback has not yet been investigated as a treatment for aphasia or other communication deficits due to stroke or neurodegenerative disease, it may be effective. Previous studies have observed improvement in cognitive and behavioral measures in those with conditions such as Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder. Furthermore, it has been associated with reduced anxiety and sleep disruption, which both exacerbate language and communication impairments. Research is needed to determine if neurofeedback may be an effective treatment for language disorders such as PPA and post-stroke communication disorders.
It is possible that EEG neurofeedback, which focuses on improving abnormal brainwave patterns, could provide certain therapeutic benefits to individuals with PPA or post-stroke aphasia, either by directly affecting neural networks that underlie language, or more generally by reducing anxiety and inattention through behavioral conditioning. Reduction of anxiety in neurological diseases can be beneficial not only for functional performance but also sleep duration and quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PPA or aphasia secondary to stroke and presence of naming deficits with confirmation of diagnosis by neurologist
- •Capable of giving informed consent or indicating another to provide informed consent
- •Age 18 or older.
- •If aphasia is secondary to stroke, the stroke must have occurred between 6 months and 5 years prior to enrollment in the study.
排除标准
- •Lack of English proficiency
- •Not medically stable
- •Picture naming accuracy above 80% on the Philadelphia Naming Test (PNT)
- •Prior history of neurologic disease affecting the brain (e.g., brain tumor, multiple sclerosis, traumatic brain injury) other than stroke or PPA and its underlying neurological pathologies: Alzheimer's Disease, Frontotemporal Lobar Degeneration or Dementia with Lewy bodies
- •Prior history of severe psychiatric illness, developmental disorders or intellectual disability (e.g., PTSD, major depression, bipolar disorder, schizophrenia, obsessive compulsive disorder (OCD), autism spectrum disorders)
- •Uncorrected severe visual loss or hearing loss by self-report and medical records
研究组 & 干预措施
Active EEG Neurofeedback
15 sessions of active EEG neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
干预措施: EEG Neurofeedback (Device)
Sham Feedback
15 sessions of sham neurofeedback at a frequency of 3-5 sessions per week for a duration of 3-5 weeks.
干预措施: Sham Feedback (Device)
结局指标
主要结局
Change in Number of Items Correctly Named on the Philadelphia Naming Test
时间窗: Baseline, 1 week following each intervention period
Change in number of items correctly named on a behavioral picture naming assessment. The score range is 0 - 175 (higher scores reflect more accurate naming/better naming ability)
次要结局
- Change in Sleep Medication Frequency(Baseline, 1 week following each intervention period and 8 weeks following both intervention periods)
- Change in Controlled Oral Word Association Test (COWA) Score(Baseline, 1 week following each intervention period)
- Change in Quality of Sleep as Assessed by the Pittsburgh Sleep Quality Index (PSQI)(Baseline, 1 week following each intervention period and 8 weeks following both intervention periods)
- Change in Anxiety as Assessed by the State Trait Anxiety Inventory (STAI)(Baseline, 1 week following each intervention period and 8 weeks following both intervention periods)
- Change in Sleep Medication Dosage(Baseline, 1 week following each intervention period)
- Change in Absolute Power on EEG(Baseline, 1 week following each intervention period)
- Change in Peak Amplitude Frequency on EEG(Baseline, 1 week following each intervention period)
- Change in EEG Absolute Power Z-scores(Baseline, 1 week following each intervention period)
- Change in EEG Peak Amplitude Frequency Z-scores(Baseline, 1 week following each intervention period)
- Change in EEG Coherence Z-scores(Baseline, 1 week following each intervention period)