Testing Personalized High Definition Transcranial Direct Current Stimulation (HD-tDCS) as a Treatment of Posterior Cortical Atrophy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in network connectivity measured via fMRI
研究概览
简要总结
This study is being completed to learn if high-definition transcranial direct current stimulation (HD-tDCS) has an effect on visual and thinking abilities in persons with posterior cortical atrophy (PCA). Participants will be randomized to receive real or sham HD-tDCS (8 sessions over 4 days).
Following the randomized treatment, participants will have optional open-label phase with real HD-tDCS up to 26 weeks and other possible testing.
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
- Double (Participant, Investigator)
盲法说明
Randomized first 4 days of treatment.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis or symptoms consistent with PCA
- •Fluent in English
- •HD-tDCS compatible
- •Stable on relevant medications for at least approximately 4 weeks prior to study enrollment
- •If completing any additional, optional, long-term study visits in a remote location (i.e., not our office), a study partner is required in order to administer HD-tDCS. Those choosing to return to our office may have, but are not required to have, a study partner.
排除标准
- •Other relevant neurological disease (e.g., epilepsy) or injuries (e.g., large vessel stroke, moderate-severe traumatic brain injury) viewed as primary to deficits since these could interfere with etiologic considerations and confound study results
- •Active, relevant psychiatric conditions (e.g., bipolar disorder, schizophrenia) since the symptoms of these conditions may confound study participation.
- •A recent (e.g., within the past 2 years) significant history of, or current, alcohol or drug abuse/dependence. Remote history of abuse/dependence is not exclusionary as long as it is not considered to be the primary etiology for visuospatial deficits.
- •Women that are lactating/breastfeeding, pregnant, or may potentially be pregnant will be excluded from the study.
研究组 & 干预措施
Real stimulation - Randomized
Four consecutive days (2 sessions for 20 minutes each day for a total of 8 sessions) of this blinded stimulation.
干预措施: HD-tDCS sessions (Device)
Sham stimulation - Randomized
Four consecutive days (2 sessions for 20 minutes each day for a total of 8 sessions) of this blinded stimulation.
干预措施: Sham HD-tDCS sessions (Device)
Real stimulation - post randomized treatment
Participants that agree to this will have up to 26 weeks of additional HD-tDCS sessions at home or in-person.
干预措施: HD-tDCS sessions - Open-label (after randomized treatment) (Device)
结局指标
主要结局
Change in network connectivity measured via fMRI
时间窗: Baseline and Day 5 (after 4 days of HD-tDCS)
Functional connectivity measures whether activity in different brain regions show similar patterns of change over time. Graph theory metrics of resting-state fMRI can characterize functional connectivity within the Dorsal Attention Network (DAN).
Measure of form coherence
时间窗: Baseline and at end of study intervention (up to 6 months)
This will evaluate dorsal and ventral visual stream functioning using a visual paradigm.
Long-term change in network connectivity via fMRI
时间窗: Baseline and end of study intervention (up to 6 months)
Functional connectivity measures whether activity in different brain regions show similar patterns of change over time. Graph theory metrics of resting-state fMRI can characterize functional connectivity within the Dorsal Attention Network.
Measures of motion tasks
时间窗: Baseline and at end of study intervention (up to 6 months)
This will evaluate dorsal and ventral visual stream function. Motion coherence is measured using a visual paradigm.
次要结局
- Measures of motion tasks(Baseline and day 5 (after 4 days of HD-tDCS))
- Measure of form coherence tasks(Baseline and day 5 (after 4 days of HD-tDCS))
- Eye tracking - Number of fixations(Baseline and day 5 (after 4 days of HD-tDCS))
- Self-ratings of cognitive change using the Posterior Cortical Atrophy Questionnaire (PCA-Q)(Baseline and at end of study intervention (up to 6 months))
- Immersive virtual reality (IVR) path length(Baseline and at end of study intervention (up to 6 months))
- functional near infrared spectroscopy (fNIRS) - Activation magnitude of DAN (processed)(Baseline and at end of study intervention (up to 6 months))
- Partner rating of cognitive change using the PCA-Q(Baseline and at end of study intervention (up to 6 months))
- Eye tracking - Number of fixations(Baseline and at end of study intervention (up to 6 months))
- Self-ratings of cognitive change using the Posterior Cortical Atrophy Questionnaire (PCA-Q)(Baseline and day 5 (after 4 days of HD-tDCS))
- Partner rating of cognitive change using the PCA-Q(Baseline and day 5 (after 4 days of HD-tDCS))
研究者
Benjamin Hampstead, PhD
Professor
University of Michigan