Combined tDCS and Cognitive Training to Reduce Impulsivity in Patients With Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Change in Barratt Impulsiveness Scale (BIS)
研究概览
简要总结
Behavioral changes following a traumatic brain injury (TBI) are one of the biggest challenges for patients, as well as their family members and others involved in their recovery. One of the most common behavioral changes following TBI is the emergence of impulsive behavior, which has been associated with destructive, suicidal, and aggressive behavior, and is related to poor rehabilitation program adherence. The primary objective of this study is to investigate the effect of a novel neuroplasticity based intervention that combines cognitive training and transcranial direct current stimulation (tDCS) to reduce impulsivity and to improve outcomes and quality of life for those who have suffered a TBI.
详细描述
Behavioral changes following a traumatic brain injury (TBI) are one of the biggest challenges for patients, as well as their family members and others involved in their recovery. One of the most common behavioral changes following TBI is the emergence of impulsive behavior, which has been associated with destructive, suicidal, and aggressive behavior, and is related to poor rehabilitation program adherence. The primary objective of this study is to investigate the effect of a novel neuroplasticity based intervention approach utilizing transcranial direct current stimulation (tDCS) to alter brain neuroplasticity combined with cognitive training tasks selected to functionally target cognition and brain circuits that are impaired in those TBI patients with impulsive behavior.
This double-blind, randomized, placebo (sham) controlled study will recruit 30 Veterans with a history of mild, moderate or severe TBI, who exhibit a variety of impulsive behaviors. Participants will be randomly assigned to receive either active or sham tDCS, both paired with cognitive training tasks, once a day for five days. Additionally, participants will attend three follow up visits at 1, 2, and 3 months after the course of intervention visits is completed. Functional magnetic resonance imaging (fMRI) will be collected before and after intervention, to measure brain activity changes across time depending on intervention type.
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, 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
- 是
入选标准
- •Participants will be included in the study if they:
- •have a clinical history of impulsive behavior, including substance abuse, gambling problems, legal issues such as DUI, violent acts, aggression, history of suicidality, or ADHD as assessed by the patient's clinical provider and/or screen of medical records
- •are age 18 or older
- •are receiving services from the Minneapolis VA Health Care System
- •are stable on any medications for at least 1 week at the baseline visit
- •have a diagnosis of mild, moderate, or severe TBI (as defined by VA/DoD Clinical Practice Guidelines criteria)
排除标准
- •Persons will be excluded from this study if they:
- •have a significant neurological disorder based on the Principal Investigators judgment that would impact risk
- •diagnosed with current active psychosis or mania
- •have metallic cranial plates/screws or implanted devices
- •have eczema on scalp or other scalp lesions or skin disorders that may become irritated by stimulation
- •are pregnant
研究组 & 干预措施
Active tDCS
Participants will receive 5 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over left frontal cortex, cathode over right frontal cortex; 2 mAmps for 20 minutes).
干预措施: Active Transcranial Direct Current Stimulation (tDCS) (Device)
Sham tDCS
Participants will receive 5 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session.
干预措施: Sham Transcranial Direct Current Stimulation (tDCS) (Device)
结局指标
主要结局
Change in Barratt Impulsiveness Scale (BIS)
时间窗: Change between baseline and 1 week follow-up; 1, 2, and 3 months following intervention
Differences in magnitude of change in BIS scores between active tDCS and sham groups from baseline to follow-up sessions. Higher total score on the BIS indicates higher levels of impulsivity.
次要结局
- Change in Brain Functional Connectivity as measured by functional magnetic resonance imaging (fMRI)(Change between baseline and 1 week follow-up)
- Change in choice of higher risk option in the Risk Task(Change between baseline and 1 week follow-up; 1, 2, and 3 months following intervention)
研究者
Casey Gilmore, PhD
Research Scientist
Minneapolis Veterans Affairs Medical Center