Assessment of tDCS-Induced Neuronal Responses in Multiple Sclerosis (MS) With Advanced MRI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Neuronal Reactivity (NR)
研究概览
简要总结
The objective of this trial is to measure the changes in neural activities during tDCS session using Magnetic Resonance Imaging (MRI). Participants (N=60) (20 Healthy Controls and 40 participants with neurological disorders, ie. multiple sclerosis) will be recruited to complete self-report measures and a brief cognitive assessment and then undergo an hour long stand-alone MRI scan while simultaneously undergoing tDCS stimulation. Methodology for this study is the administration of 15-minutes of of active tDCS during MRI acquisition compared to time without active tDCS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for MS Patients:
- •Participants must be 18 years of age or older
- •Standardized SDMT Z-score > - 3.0
- •Fatigue Severity Scale score > 36
- •Definite MS diagnosis as assessed by licensed physician any subtype including Relapsing Remitting (RRMS), Primary Progressive (PPMS) or Secondary Progressive (SPMS)
- •Score of ≤ 7.0 on the Expanded Disability Status Scale
- •Clinically stable without disease progression in the past 3 months
- •Has stable and continuous access to internet service at home compatible with the study laptop (Wi-Fi or Ethernet cable)
- •Adequate internet capacity for remote monitoring, as tested by http://www.speedtest.net/
- •Adequate home facilities (enough space, access to quiet and distraction free area)
- •Able to commit to the four-week period of training sessions with baseline and two follow-up visits
排除标准
- •for MS Patients:
- •Extreme claustrophobia
- •Relapse or steroid use in previous month
- •History of mental retardation, pervasive developmental disorder, or other neurological condition associated with cognitive impairment
- •Primary psychiatric disorder that would influence ability to participate
- •Current uncontrolled seizure disorder
- •Current substance abuse disorder
- •Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
- •Treatment for a communicable skin disorder currently or over the past 12 months
- •Have any irremovable piercings, MRI-contraindicated implantations or metallic based-tattoos
- •Pregnant or breastfeeding
- •Wide Range Achievement Test-4th Edition (WRAT-4) Reading Recognition Scaled Score < 85
- •Beck Depression Inventory - Fast Screen (BDI-FS) score > 9
- •Inclusion Criteria for Healthy Controls:
- •Participants must be 18 years of age or older
- •Standardized SDMT Z-score > - 3.0
- •Have not been diagnosed with MS or other neurological disorder
- •Adequate internet capacity for remote monitoring, as tested by http://www.speedtest.net/ (HC subgroup only)
- •Adequate home facilities including enough space, access to quiet and distraction free area (HC subgroup only)
- •Able to commit to the four-week period of training sessions with baseline and one follow-up visit (HC subgroup only)
- •Exclusion Criteria for Healthy Controls:
- •Extreme claustrophobia
- •History of mental retardation, pervasive developmental disorder or other neurological condition associated with cognitive impairment
- •Primary psychiatric disorder that would influence ability to participate
- •Current uncontrolled seizure disorder
- •Current substance abuse disorder
- •Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
- •Treatment for a communicable skin disorder currently or over the past 12 months
- •Have any irremovable piercings, MRI-contraindicated implantations or metallic based-tattoos
- •Pregnant or breastfeeding
研究组 & 干预措施
Healthy Controls
Healthy Controls will be given approximately 15 minutes of active tDCS during MRI during the initial visit.
干预措施: tDCS Administration during MRI (Device)
MS Patients
MS patients will be given approximately 15 minutes of active tDCS during MRI during the initial visit. After the first MRI visit, MS patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC. Around 3 months after the 20-session treatment, MS patients only will be asked to come to the clinic for neuropsychological assessments.
干预措施: tDCS Administration during MRI (Device)
MS Patients
MS patients will be given approximately 15 minutes of active tDCS during MRI during the initial visit. After the first MRI visit, MS patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC. Around 3 months after the 20-session treatment, MS patients only will be asked to come to the clinic for neuropsychological assessments.
干预措施: Remotely-supervised Daily tDCS Administration (Device)
Healthy Control subgroup
The Healthy Control subgroup will be given approximately 15 minutes of active tDCS during MRI during the initial visit. Participants in the healthy control subgroup will be given the option to have an additional 15 minutes of brain imaging, which will include 10 minutes of simultaneous tDCS at up to 4.0mA, added to the end of their baseline scan. After the first MRI visit, HC subgroup patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC.
干预措施: tDCS Administration during MRI (Device)
Healthy Control subgroup
The Healthy Control subgroup will be given approximately 15 minutes of active tDCS during MRI during the initial visit. Participants in the healthy control subgroup will be given the option to have an additional 15 minutes of brain imaging, which will include 10 minutes of simultaneous tDCS at up to 4.0mA, added to the end of their baseline scan. After the first MRI visit, HC subgroup patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC.
干预措施: Remotely-supervised Daily tDCS Administration (Device)
Healthy Control subgroup
The Healthy Control subgroup will be given approximately 15 minutes of active tDCS during MRI during the initial visit. Participants in the healthy control subgroup will be given the option to have an additional 15 minutes of brain imaging, which will include 10 minutes of simultaneous tDCS at up to 4.0mA, added to the end of their baseline scan. After the first MRI visit, HC subgroup patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC.
干预措施: Optional 15 minutes of imaging + simultaneous tDCS up to 4.0mA (Device)
结局指标
主要结局
Neuronal Reactivity (NR)
时间窗: Baseline, Intermediate Visit (Month 1)
NR represents tDCS-induced global neural reactivity measured by CMRO2 levels in cells available to respond to neural stimuli. NR is measured as the percentage change of CMRO2 from no tDCS to real tDCS.
Cerebral Metabolic Rate of Oxygen (CMRO2)
时间窗: Intermediate Visit (Month 1)
Measured via MRI. CMRO2 is the amount of O2 the brain consumes per unit of time (in μmol O2/100g tissue per minute)
Cerebral Metabolic Rate of Oxygen (CMRO2)
时间窗: Baseline Visit
Measured via MRI. CMRO2 is the amount of O2 the brain consumes per unit of time (in μmol O2/100g tissue per minute)
Neuronal Reactivity (NR)
时间窗: Baseline Visit (pre-tDCS, post-tDCS)
NR represents tDCS-induced global neural reactivity measured by CMRO2 levels in cells available to respond to neural stimuli. NR is measured as the percentage change of CMRO2 from no tDCS to real tDCS. tDCS will be administered in one visit and will last for approximately 15 minutes.
次要结局
- Quality of Life in Neurological Disorders (Neuro-QOL) Score(Final Visit (Month 4))
- Quality of Life in Neurological Disorders (Neuro-QOL) Score(Baseline Visit)
- Quality of Life in Neurological Disorders (Neuro-QOL) Score(Intermediate Visit (Month 1))