Transcranial Photobiomodulation for Executive Function in Bipolar Disorder (TPEB)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Test the Effect of Transcranial Photobiomodulation (tPBM) on Cerebral Blood Flow (CBF)
研究概览
简要总结
Transcranial light therapy, or transcranial photobiomodulation (tPBM), is a treatment that stimulates the brain by applying near-infrared light to the forehead. Transcranial light therapy has been found to promote brain metabolism, which may help improve executive function in people with bipolar disorder. The research team proposes a novel approach to treating bipolar disorder by using transcranial light therapy.
详细描述
This study involves a virtual screening visit, 7 in-office visits, and a virtual check-in call with a clinician. Participation will last approximately 3 weeks in total.
Participants will attend a baseline visit during which they will complete mood questionnaires and a gambling task. Participants will then receive five treatments of transcranial light therapy over one week. The first and last of these treatments will be administered while the participant is in an MRI scanner. At the first visit, participants will also receive a "sham" tPBM treatment, meaning that the device will simulate real treatment, but will not actually apply the near-infrared light. The check-in call will occur approximately 2-3 days after the final treatment visit. This will be a brief call with a study clinician to check-in on the participant's mental and physical health. The follow up visit will occur approximately one week after the final visit. Subjects will be asked to complete mood questionnaires and/or gambling tasks during the first and fifth treatment visits, as well as at the follow up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
During the first treatment visit within the MRI, participants will receive one active tPBM treatment and one sham tPBM treatment. Participants will be blinded as to the order in which they receive these treatments.
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
- •Adults between the ages of 18 and 65
- •Diagnosis of bipolar disorder
- •Currently experiencing symptoms of impulsivity
- •Vision normal or corrected to normal with contacts
排除标准
- •Currently in depressive, manic, or mixed episode
- •Currently psychotic
- •Judged to be at serious and imminent suicidal risk
- •Currently in alcohol or substance use disorder (meeting criteria in the past 3 months)
- •Unstable medical conditions
- •Inability to consent or to complete study procedures
- •Failure to meet standard MRI safety requirements (e.g. claustrophobia, non-removable piercings, implanted medical devices, other non-removable metals)
- •Changes in medications or use of augmentative devices and other interventions in the 2 weeks prior to the study
- •Participation in other clinical research trials that may influence primary outcomes or adherence to the proposed study
- •Current pregnancy.
结局指标
主要结局
Test the Effect of Transcranial Photobiomodulation (tPBM) on Cerebral Blood Flow (CBF)
时间窗: Day 1 of tPBM Treatment
Compare blood-oxygenation-level-dependent (BOLD) signal during sham stimulation at Day 1 versus BOLD signal during active stimulation at Day 1. Increased BOLD signal is thought to reflect increased brain activity, and thus a positive outcome. In this specific case, higher BOLD signal during active as compared to sham treatment in the right dorsolateral prefrontal cortex (rDLPFC) is thought to reflect target engagement, that is the tPBM device which is placed on the right forehead is in fact irradiating and having an effect on brain function within the rDLPFC.
Test Effect of tPBM on CBF
时间窗: Day 1 and Day 5
Compare BOLD signal during active stimulation at Day 1 versus active stimulation at Day 5. Greater BOLD signal at Day 5 compared to Day 1 would indicate an increase in brain activity following active treatment, supporting tPBM target engagement.
次要结局
- Test the Effect of tPBM on Impaired Decision Making(Baseline to Follow-Up)
- Test the Effect of Repeated t-PBM Sessions on Mood Symptoms (MOODS-SR) in Subjects With Bipolar Disorder (BD)(Baseline to Follow Up)
研究者
Paolo Cassano
Director of Photobiomodulation
Massachusetts General Hospital