Neuromodulation and Neurorehabilitation for Treatment of Functional Deficits After mTBI and PTSD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Change in the Mayo Portland Adaptability Inventory (MPAI)
研究概览
简要总结
This study will determine (i) the magnitude of immediate and sustained effects of a current clinical standard interactive computer attention processing training (APT) when combined with intermittent theta burst stimulation (iTBS), a type of repetitive transcranial magnetic stimulation and (ii) determine how APT + iTBS changes the neurocognitive system of attention in individuals with persistent attention deficits related to mTBI +/- PTSD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age and no older than 80 years of age
- •3 months post exposure to mTBI event
- •Have a history of mTBI with PTSD OR mTBI without PTSD as defined by formalized measures to classify mTBI based on the Symptom Attribution and Classification Algorithm (SACA) and the PTSD Module L of the SCID
- •Endorse at least moderate severity on at least one of the four cognitive complaints in the Neurobehavioral Symptom Inventory
排除标准
- •Participating in another research study
- •Non-fluent in English (speaking and reading)
- •History of epilepsy pre-injury
- •Receiving antiepileptic treatment for documented active seizures in the past 6 months
- •Taking medications that lower seizure threshold including antipsychotics, trazodone and tramadol
- •History of surgery on blood vessels in brain and/or valves of the heart
- •History of brain hemorrhage, neurovascular conditions and neurodegenerative disorders
- •History or current diagnosis of psychotic spectrum disorders (i.e. bipolar, schizophrenia)
- •Significant heart disease as determined by physician review of medical chart
- •Pregnant at time of enrollment or any time during study participation
- •MRI or TMS/iTBS contraindications such as claustrophobia, metal in eyes/face or brain
- •Cardiac pacemakers/defibrillators, cochlear implants, nerve stimulators, intracranial metal clips
- •Diagnosis of moderate or severe TBI (loss of consciousness > 30 minutes, alteration of consciousness > 24 hours, post traumatic amnesia or neuropsychological testing results
- •Prescribed dosage of mental health medications have been altered within the month preceding study screening. Any participant whose mental health medication(s) has/have changed, within 30 days of study screening. The following are considered a medication change: the addition of or discontinuation of medication, a change in the dose or dosage (daily amount) of medication.
- •Taking prescribed CNS stimulants and choosing to not stop these medications during study participation
- •Taking prescribed CNS stimulants and choosing to not stop these medications during study participation
- •Testing positive for opiates and do not have a prescription for opiates. If on prescription opiates and taking more than the equivalent of 200 mg of morphine per day.
- •Questionably valid test performance as indicated by a score of ≤ 85% on the Immediate Recognition, Delayed Recognition or Consistency Scales of the Medical Symptom Validity Test (MSVT) and clinical determination of questionable performance validity by a neuropsychologist on the research team
- •Actively suicidal as evidenced by plan to harm or recent attempt communicated on the Structured Clinical Interview for DSM-V (SCID-5).
- •Increased Intracranial Pressure (ICP) as evidenced through a funduscopic evaluation or on the baseline MRI scan.
- •Moderate or severe cannabis use disorder defined by ≥ 4 symptoms on the SCID-5
- •Severe alcohol use disorder defined by ≥ 6 symptoms on the SCID-5
- •Baseline systolic BP greater or equal to 170
研究组 & 干预措施
real APT+ real iTBS
real APT+ real iTBS included 30 1-hour treatment sessions will be provided 3/week. Sessions will be conducted for 10 weeks. APT-III is a computer based cognitive training program. iTMS will be applied at 5Hz rate; each burst consists of 3 pulses delivered at 50Hz rate. The bursts are applied for 2s with 8s inter-burst-intervals, for a total of 600 pulses. The total stimulation time per session is approximately 192s (~ 3 minutes). Participants randomized to active iTBS will receive stimulation at the right dorsolateral prefrontal cortex at 80% active motor threshold .
干预措施: real iTBS (Device)
real APT+ real iTBS
real APT+ real iTBS included 30 1-hour treatment sessions will be provided 3/week. Sessions will be conducted for 10 weeks. APT-III is a computer based cognitive training program. iTMS will be applied at 5Hz rate; each burst consists of 3 pulses delivered at 50Hz rate. The bursts are applied for 2s with 8s inter-burst-intervals, for a total of 600 pulses. The total stimulation time per session is approximately 192s (~ 3 minutes). Participants randomized to active iTBS will receive stimulation at the right dorsolateral prefrontal cortex at 80% active motor threshold .
干预措施: real APT (Behavioral)
real APT + placebo iTBS
30 1-hour treatment sessions will be provided 3/week. Sessions will be conducted for 10 weeks. APT-III is a computer based cognitive training program. Participants randomized to placebo iTBS will not receive any iTBS stimulation.
干预措施: real APT (Behavioral)
real APT + placebo iTBS
30 1-hour treatment sessions will be provided 3/week. Sessions will be conducted for 10 weeks. APT-III is a computer based cognitive training program. Participants randomized to placebo iTBS will not receive any iTBS stimulation.
干预措施: placebo iTBS (Device)
placebo APT+ real iTBS
30 1-hour treatment sessions will be provided 3/week. Sessions will be conducted for 10 weeks. Placebo APT-III is a computer based active control cognitive training program. Bursts of TMS pulses will be applied at 5Hz rate; each burst consists of 3 pulses delivered at 50Hz rate. The bursts are applied for 2s with 8s inter-burst-intervals, for a total of 600 pulses. The total stimulation time per session is approximately 192s (~ 3 minutes). Participants randomized to active iTBS will receive stimulation at the right DLPFC at 80% active motor threshold .
干预措施: placebo APT (Behavioral)
placebo APT+ real iTBS
30 1-hour treatment sessions will be provided 3/week. Sessions will be conducted for 10 weeks. Placebo APT-III is a computer based active control cognitive training program. Bursts of TMS pulses will be applied at 5Hz rate; each burst consists of 3 pulses delivered at 50Hz rate. The bursts are applied for 2s with 8s inter-burst-intervals, for a total of 600 pulses. The total stimulation time per session is approximately 192s (~ 3 minutes). Participants randomized to active iTBS will receive stimulation at the right DLPFC at 80% active motor threshold .
干预措施: real iTBS (Device)
placebo APT+ placebo iTBS
30 1-hour treatment sessions will be provided 3/week. Sessions will be conducted for 10 weeks. Placebo APT-III is a computer based active control cognitive training program. Participants randomized to placebo iTBS will not receive any iTBS stimulation.
干预措施: placebo APT (Behavioral)
placebo APT+ placebo iTBS
30 1-hour treatment sessions will be provided 3/week. Sessions will be conducted for 10 weeks. Placebo APT-III is a computer based active control cognitive training program. Participants randomized to placebo iTBS will not receive any iTBS stimulation.
干预措施: placebo iTBS (Device)
结局指标
主要结局
Change in the Mayo Portland Adaptability Inventory (MPAI)
时间窗: baseline, 5 weeks, 10 weeks, 20 weeks
Self-reported ability, adjustment and community participation. It is comprised of 30 items and three subscales: Ability Index, Adjustment Index and Participation Index. Items are scored on a 5-point Likert scale, with lower scores indicating higher levels of functioning.
次要结局
- change in the PTSD Checklist (PCL)(baseline, 5 weeks, 10 weeks, 20 weeks)
研究者
Theresa Pape
Research Health Scientist
Northwestern University