Treatment of Cognitive Deficits in Multiple Sclerosis With High-Definition Transcranial Direct Current Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Treatment group differences in change from Baseline to 1-week Post-Treatment on Category Fluency
研究概览
简要总结
The purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., presupplementary motor area) thought to aid in memory will improve verbal retrieval in multiple sclerosis patients. The primary outcome measures are neuropsychological assessments of verbal retrieval, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures. Additionally, the study will examine the degree to which baseline assessments of cognition and concussion history predict responses to treatment over time, both on assessments administered within the intervention period and at follow-up.
详细描述
Using two treatment arms, the study will examine improvement of verbal retrieval and other cognitive deficits associated with multiple sclerosis by comparing (1) 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to presupplementary motor area for 20 minutes over 10 sessions to (2) sham tDCS following the same schedule. Additionally, after completing the initial active or sham treatment and immediate and 2-month follow-up testing sessions, selected participants will be invited back for newly assigned treatment conditions, 20 minutes over 10 sessions and will be re-evaluated at immediate and 2-month follow-up testing sessions.
Patients with multiple sclerosis and observed cognitive deficits will be randomly assigned to one of the two treatment arms (and re-assigned for the second round of intervention, as described above). Primary outcome verbal retrieval measures, secondary neuropsychological and electroencephalography (EEG) measures, and prescreening assessments for study concussion history and contraindications for treatment will be collected prior to being assigned to a treatment arm (i.e., baseline).
Primary outcome verbal retrieval measures and secondary neuropsychological and electroencephalography (EEG) measures will be at baseline and two times following treatment competition (i.e., immediate and 2-months). For participants selected for the second round of intervention, primary outcome verbal memory measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected again two times immediately following completion of the last treatment and 2-months afterward.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, assessors, and technicians interacting with participants will be blind to assigned conditions. The software for the transcranial direct current system allows for maintaining blinds when uploading and running protocols.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •º Diagnosed with relapsing-remitting multiple sclerosis (RRMS)
- •º Memory retrieval deficit based on neuropsychological testing done in our lab
- •º Must be fluent in speaking and reading English.
排除标准
- •º Relapse or acute MS exacerbation or a course of steroids in the two months preceding the testing
- •º Participants using benzodiazepines must have been on a stable dose for at least two months
- •º Potentially confounding psychological or neurological disorder, including:
- •dementia of any type
- •epilepsy or other seizure disorders
- •severe traumatic brain injury
- •brain tumor
- •present drug abuse
- •blood vessel abnormalities in the brain
- •Parkinson's disease
- •Huntington's disease
- •º inability to give informed consent
- •º cranial implants
- •º skull defects that affect tDCS administration
- •º use of medications that interact with or potentially interact with tDCS effects, including:
- •anti-convulsants
- •carbamazepine
- •sulpiride
- •pergolide
- •lorazepam
- •rivastigmine
- •dextromethorphan
- •D-cycloserine
- •flunarizine
- •ropinirole
- •stimulants (dextroamphetamine/amphetamine/modafinil/armodafinil) must be stopped during enrollment
研究组 & 干预措施
Sham transcranial direct current stimulation
Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of electrodes placed at Fz, F7, FP1, FP2, and F8 (International 10/10 System for electroencephalography electrode placement). All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes.
干预措施: Sham transcranial direct current stimulation (Device)
Transcranial direct current stimulation
Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds.
Other Names:
tDCS
1 milliamp tDCS High definition tDCS High definition transcranial direct current stimulator, Neuroelectrics Starstim tES, SN E20200930-10
干预措施: Transcranial Direct Current Stimulation (Device)
结局指标
主要结局
Treatment group differences in change from Baseline to 1-week Post-Treatment on Category Fluency
时间窗: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Evaluation of treatment group differences in change on Category Fluency from baseline to 1-week post-treatment. Metric: Number of Correct Items Generated
Treatment group differences in change from Baseline to 1-week Post-Treatment on COWAT
时间窗: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
Evaluation of treatment group differences in change on COWAT from baseline to 1-week post-treatment. Metric: Number of Correct Items Generated
Treatment group differences in change from Baseline to 2-months Post-Treatment on Category Fluency
时间窗: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
Evaluation of treatment group differences in change on Category Fluency from baseline to 2-months post-treatment. Metric: Number of Correct Items Generated
Treatment group differences in change from Baseline to 2-months Post-Treatment on COWAT
时间窗: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Evaluation of treatment group differences in change on COWAT from baseline to 2-months post-treatment. Metric: Number of Correct Items Generated
次要结局
- Treatment group differences in change from Baseline to 1-week Post-Treatment on the Digit Span Backward(Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment)
- Treatment group differences in change from Baseline to 2-months Post-Treatment on the Delis Kaplan Color Word Interference Test(Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment)
- Treatment group differences in change from Baseline to 1-week Post-Treatment on on the Digit Span Forward(Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment)
- Treatment group differences in change from Baseline to 1-week Post-Treatment on on the the Rey-Osterrieth Complex Figure Test(Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment)
- Treatment group differences in change from Baseline to 2-months Post-Treatment on the Auditory Verbal Learning Test(Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment)
- Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Inhibition Task EEG spectral power(Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 2-months Post-Treatment)
- Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Object Retrieval EEG event-related potential(Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment)
- Treatment group differences in change from Baseline to 1-week Post-Treatment on the Trail Making Test (Part B)(Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment)
- Treatment group differences in change from Baseline to 1-week Post-Treatment on the Delis Kaplan Color Word Interference Test(Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment)
- Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Object Retrieval Test(Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment)
- Treatment group differences in change from Baseline to 1-week Post-Treatment on the Auditory Verbal Learning Test(Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment)
- Treatment group differences in change from Baseline to 2-months Post-Treatment on the Trail Making Test (Part A)(Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment)
- Treatment group differences in change from Baseline to 1-week Post-Treatment on the Trail Making Test (Part A)(Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment)
- Treatment group differences in change from Baseline to 1-week Post-Treatment on the Digit Symbol Substitution Test(Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment)
- Treatment group differences in change from Baseline to 1-week Post-Treatment on the Grooved Pegboard Test(Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment)
- Treatment group differences in change from Baseline to 1-week Post-Treatment on the Boston Naming Test(Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment)
- Treatment group differences in change from Baseline to 2-months Post-Treatment on the Trail Making Test (Part B)(Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment)
- Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Span Forward(Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment)
- Treatment group differences in change from Baseline to 2-months Post-Treatment on the Rey-Osterrieth Complex Figure Test(Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment)
- Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Symbol Substitution Test(Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment)
- Treatment group differences in change from Baseline to 2-months Post-Treatment on the Grooved Pegboard Test(Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment)
- Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Span Backward(Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment)
- Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Object Retrieval EEG spectral power(Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment)
- Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Object Retrieval Test(Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment)
- Treatment group differences in change from Baseline to 2-months Post-Treatment on the Boston Naming Test(Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment)
- Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Inhibition Task EEG spectral power(Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment)
- Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Inhibition Task EEG Event-Related Potential (N2/P3)(Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment)
- Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Object Retrieval EEG event-related potential(Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment)
- Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Inhibition Task EEG Event-Related Potential (N2/P3)(Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment)
- Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Object Retrieval EEG spectral power(Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 1-week Post-Treatment)
研究者
John Hart, Jr.
Professor
The University of Texas at Dallas