Targeted Transcranial Magnetic Stimulation for Cognitive Rehabilitation After Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Auditory target detection task
研究概览
简要总结
A novel and promising therapy for cognitive dysfunction is non-invasive brain stimulation, of which transcranial magnetic stimulation (TMS) is a form. TMS is currently FDA-approved for use in depression and migraine. It is under investigation for use in a number of other neurologic and psychiatric disorders. In addition to its potential to improve affective symptoms, recent research has suggested that TMS targeted to select cortical regions can also improve cognition. In trials of TMS therapy for psychiatric disorders, several studies have shown benefits for cognitive function alongside symptom amelioration. In healthy persons, a course of stimulation of the parietal area improved objective measures of learning and memory. Among persons with TBI, there have been case reports supporting improvement in cognitive function and postconcussive symptoms; however, there have not yet been any controlled studies of TMS for TBI-related cognitive dysfunction.
详细描述
Subjects with a history of TBI will be recruited into this double-blind, sham controlled, crossover with washout study design. Study will involve one week (5 consecutive days) of treatment, a 7 day off period, followed by a second week of rTMS treatment. Motor threshold will determine level of stimulation, and active rTMS stimulation will occur of the right DLPFC. Subjects will be paid for their time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
double blinded
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
- •one or more mild to moderate TBIs*;
- •at least one year but no more than 20 years from worst injury;
- •ability to complete cognitive and neurophysiological testing;
- •available for duration of study;
- •between 18 and 65 years of age;
- •mild or greater cognitive symptoms on the TBI-QOL Cognition General Concerns scale
排除标准
- •severe or penetrating TBI;
- •history of psychotic or manic illness;
- •history of intracranial surgery;
- •history of skull fracture;
- •history of seizures in candidate or candidate's family
- •ferrous metallic implants or implantable medical device;
- •medications that are known to reduce seizure threshold;
- •history of multiple sclerosis, stroke, brain tumor, epilepsy
结局指标
主要结局
Auditory target detection task
时间窗: 10 minutes
subjects listen to a series of sounds, and will monitor for a specific sounds.
California Verbal Learning Test II
时间窗: 10 minutes
subjects are required to learn and recall an unfamiliar word list.
DKEFS Verbal Fluency
时间窗: 10 minutes
a measure of internal search and selection process, requires subject to generate several lists of items.
Ruffs 2 and 7 selective attention test
时间窗: ~5 minutes
subjects must visually search for the numbers 2 and 7 among other distractors.
次要结局
- EEG(10 minutes)
研究者
George Gitchel
Director of Clinical Research, Parksinon's Disease Education, Research and Clinical Center (PADRECC)
Hunter Holmes Mcguire Veteran Affairs Medical Center