Remote Stimulation and Training to Advance Recovery From TBI in Seniors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score
研究概览
简要总结
The goal of this clinical trial is to learn if combining brain stimulation with cognitive training can improve thinking skills in older adults who have had a traumatic brain injury (TBI).
The main questions are:
- Does transcranial direct current stimulation (tDCS) make cognitive training more effective for improving attention, memory, and decision-making?
- Is this type of home-based program feasible and acceptable for older adults with TBI?
Researchers will compare two groups: one group will receive active tDCS during cognitive training, and the other group will receive sham (placebo) tDCS during cognitive training.
Participants will:
- Complete computer-based cognitive training exercises (BrainHQ) to practice attention, memory, and decision-making.
- Receive either active or sham tDCS during training sessions.
- Complete assessments before and after the program to measure changes in thinking and daily functioning.
详细描述
Traumatic brain injury (TBI) is a major public health issue among older adults. Each year, thousands of seniors sustain TBIs, most often from falls. Even when the injury is classified as "mild," it can lead to long-term problems with memory, attention, decision-making, and self-control. These difficulties can make it harder to live independently, maintain social relationships, and manage everyday responsibilities. Older adults with a history of TBI are also at greater risk of experiencing faster cognitive decline as they age. Unfortunately, there are few effective treatments available to improve thinking skills in this group.
This study is designed to test a new approach that combines **computer-based cognitive training** with **transcranial direct current stimulation (tDCS)**, a safe, non-invasive form of brain stimulation. The goal is to determine whether this combined treatment can improve attention, memory, and decision-making in older adults with TBI, and whether the program is practical for participants to complete at home with remote supervision.
About the Interventions
- Cognitive training (BrainHQ): Participants will complete computerized exercises that provide structured practice in skills such as attention, working memory, and decision-making. These exercises adapt to each individual's performance, gradually increasing in difficulty as skills improve.
- tDCS: During some of the training sessions, participants will wear a device with electrodes placed on the scalp. The device delivers a very low level of electrical current (2 milliamps) that helps "tune" brain networks to make them more responsive to training. tDCS is non-invasive, painless for most people, and has been tested safely in thousands of participants in research studies worldwide.
Study Design
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veterans age 65 and older.
- •History of mild TBI (as defined by the DOD/VA criteria used in conjunction with the OSU TBI-ID) sustained at least 3 months prior to enrollment.
- •Self-reported or medically documented attention and/or concentration difficulties.
- •Stable dose of all prescription and non-prescription medications that may impact cognition or brain chemistry (except for PRN medication) for at least 3 weeks prior to the baseline session (Visit 1), in the medical opinion of the principal investigator.
- •Capable and willing to provide voluntary informed consent, in the medical opinion of the principal investigator.
排除标准
- •Presence of a medical, psychiatric, physical or non-physical disease, disorder, condition, injury, disability or pre-existent history such that study participation, in the opinion of the principal investigator: (a) may pose a significant risk to the participant, (b) raises the possibility that the participant is unlikely to successfully complete all the requirements of the study according to the study protocol, or (c) might adversely impact the integrity of the data or the validity of the study results. Specific conditions include (but are not limited to) a history of brain tumor near the stimulation site, brain surgery, stroke with current sequalae, epilepsy, multiple sclerosis, Huntington's Disease, ALS, ataxia, aphasia, Alzheimer's Disease, and dementia.
- •Moderate to severe cognitive impairment with MoCA score (assessed upon enrollment) less than
- •Prior treatment with ECT or neuromodulation in the last 12 months.
- •Current severe alcohol or substance use disorder with evidence of withdrawal or tolerance within the past 6 months, based on psychiatric history and/or a review of available medical records.
- •Psychosis or mania within 30 days of enrollment, as determined by the principal investigator, based on psychiatric history and/or a review of available medical records.
- •Contraindications for tDCS (e.g., metallic cranial plates/screws or implanted device, eczema or skin lesions on scalp near electrode site, etc.).
- •No or limited internet connection in their home.
研究组 & 干预措施
Active tDCS with cognitive training
Participants will receive 10 sessions of cognitive training concurrent with transcranial direct current stimulation (45 minutes of cognitive training with tDCS applied for first 20 minutes of session; tDCS: 2mA, 30s ramp up/down, anode at F3, cathode at F4).
干预措施: Active tDCS and Cognitive Training Intervention (Combination Product)
Sham tDCS with cognitive training
Participants will receive 10 sessions of cognitive training concurrent with sham transcranial direct current stimulation (45 minutes of cognitive training with sham tDCS: 2mA current will be ramped down immediately after the initial 30s ramp up period and then at 20 minutes ramped up and down as done at the beginning, anode at F3, cathode at F4).
干预措施: Sham tDCS and Cognitive Training Intervention (Combination Product)
结局指标
主要结局
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score
时间窗: Baseline, 1-week post, & 6-weeks post intervention
The RBANS is a commonly-used, psychometrically-sound measure of cognitive function across the lifespan. The primary outcome measure is the Total Scale score, which is a standard score (mean 100, SD 15) across five cognitive domains (Immediate/Delayed Memory, Visuospatial, Attention, Language).
Electroencephalogram (EEG) - Resting State Theta Band Functional Connectivity
时间窗: Baseline, 1-week post, & 6-weeks post intervention
Resting State EEG will be collected to assess neural dynamics or functional connectivity and spectral power of delta,theta, alpha, beta, and gamma frequency bands. The primary outcome measure will be change in prefrontal-parietal functional connectivity in the theta frequency band.
次要结局
- Patient Health Questionnaire-8 (PHQ-8) Total Score(Baseline, 1-week post, & 6-weeks post intervention)
- Neurobehavioral Symptom Inventory (NSI) Total Score(Baseline, 1-week post, & 6-weeks post intervention)
- Insomnia Severity Index (ISI) Total Score(Baseline, 1-week post, & 6-weeks post intervention)
- Groton Maze Learning Task (GMLT) Completion Time(Baseline, 1-week post, & 6-weeks post intervention)
- NIH Toolbox Quality of Life Assessment (NeuroQoL)(Baseline, 1-week post, & 6-weeks post intervention)
研究者
Casey Gilmore, PhD
Principal Investigator
Minneapolis Veterans Affairs Medical Center