Pilot Study of Neuromodulation for Enhancement of Emotion Regulation in Bipolar Mood Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Affective Multisource Interference Task - Reaction Time During Negative Interference Trials
研究概览
简要总结
The investigators are conducting this research study to better understand how individuals with bipolar disorder regulate their emotions, and if the study can use a technique called "transcranial magnetic stimulation" or TMS to help improve emotion regulation for individuals with bipolar disorder.
详细描述
Emotion dysregulation contributes to the development and maintenance of a wide range of psychopathology, but is especially relevant for individuals with bipolar mood disorders (BD). These individuals experience severe and episodic emotion dysregulation associated with maladaptive functioning, interpersonal problems, decreased work productivity, and suicidal ideation and behavior. To date, both pharmacological and psychosocial treatments fail to normalize emotion dysregulation for many bipolar patients. As a consequence, all too many experience poor outcomes. Thus, there is a significant need for new innovative approaches to target and improve emotion dysregulation in bipolar patients. Non-invasive neuromodulation using transcranial magnetic stimulation (TMS) may provide a viable strategy to help improve emotion dysregulation in bipolar mood disorders. As a first step to test this hypothesis, the current proposal seeks to experimentally identify specific neural target sites for improving emotion regulation using TMS. If the investigators can demonstrate target engagement of emotion regulation at the behavioral level using TMS, this will provide an important first step towards examining the potential utility of TMS as a viable strategy to help improve emotion dysregulation in bipolar mood disorders. While this is not a definitive clinical trial, the sham-controlled double-crossover design of this study will provide valuable information for target site selection for the development of TMS as an intervention strategy to improve emotion dysregulation in BD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None (Participant)
盲法说明
Participants are blinded to whether they received active versus sham (placebo) TMS.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women
- •Ages 18-50 years
- •Patients diagnosed with bipolar I disorder (BD-I), current mood state euthymic.
- •On a stable psychiatric medication regimen for at least a month prior to and during study participation
- •Healthy Controls:
- •Men and women
- •Ages 18-50 years
- •Without major psychiatric illness
排除标准
- •Any change in psychiatric medications within a month prior to and during study participation
- •Legal or mental incompetency
- •Intellectual disability
- •Current manic (YMRS > 12) or severe depressive episode (HAM-D-17 > 5)
- •Substance use disorder (abuse or dependence) with active use within the last 3 months
- •Significant medical or neurological illness
- •Prior neurosurgical procedure
- •History of seizures
- •History of ECT treatment or clinical TMS within the past three months
- •Implanted cardiac pacemakers
- •Patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or neck, or are non-removable and within 30 cm of the treatment coil. These include:
- •Aneurysm clips or coils
- •Carotid or cerebral stents
- •Metallic devices implanted in the head (e.g. Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt)
- •Magnetically active dental implants
- •Cochlear/otologic implants
- •CSF shunts
- •Ferromagnetic ocular implants
- •Pellets, bullets, fragments less than 30 cm from the coil
- •Facial tattoos with metallic ink, permanent makeup less than 30 cm from the coil
- •Pregnant women
- •Healthy Controls:
- •History of major psychiatric illness, including psychosis
- •Has a first-degree relative with psychosis
- •Active use of neuropsychoactive medications
- •Legal or mental incompetency
- •Intellectual disability
- •Substance use disorder (abuse or dependence) with active use within the last 3 months
- •Significant medical or neurological illness
- •Prior neurosurgical procedure
- •History of seizures
- •History of ECT treatment or clinical TMS within the past three months
- •Implanted cardiac pacemakers
- •Individuals who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or neck, or are non-removable and within 30 cm of the treatment coil. These include:
- •Aneurysm clips or coils
- •Carotid or cerebral stents
- •Metallic devices implanted in the head (e.g. Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt)
- •Magnetically active dental implants
- •Cochlear/otologic implants
- •CSF shunts
- •Ferromagnetic ocular implants
- •Pellets, bullets, fragments less than 30 cm from the coil
- •Facial tattoos with metallic ink, permanent makeup less than 30 cm from the coil
- •Pregnant women
研究组 & 干预措施
Patients
Individuals with Bipolar 1 Disorder
干预措施: Transcranial Magnetic Stimulation (TMS) (Device)
结局指标
主要结局
Affective Multisource Interference Task - Reaction Time During Negative Interference Trials
时间窗: Task administered 10 minutes pre TMS and 5 minutes post TMS
The Affective Multisource Interference Task is a behavioral task measuring the ability to identify an oddball number when overlayed on affective images as a proxy for emotion regulation. Outcome Measure 1: Slope of reaction time during trials with negative valenced stimuli where the oddball number is other than zero and in a location incongruent with the location on the button box
Affective Multisource Interference Task - Reaction Time During Positive Interference Trials
时间窗: Task administered 10 minutes pre TMS and 5 minutes post TMS
The Affective Multisource Interference Task is a behavioral task measuring the ability to identify an oddball number when overlayed on affective images as a proxy for emotion regulation. Outcome Measure 2: Slope of reaction time during trials with positive valenced stimuli where the oddball number is other than zero and in a location incongruent with the location on the button box
Emotion Conflict Resolution Task - Incongruent Fear Trials Reaction Time
时间窗: Task administered 10 minutes pre TMS and 5 minutes post TMS
The Emotion Conflict Resolution Task is a behavioral task requiring correct identification of an emotion word overlayed on photographs of facial expressions of emotion. Outcome measure 3: Slope of reaction time during trials when the image is of a fearful facial expression but the word is "Happy" (incongruent)
Emotion Conflict Resolution Task - Incongruent Happy Trials Reaction Time
时间窗: Task administered 10 minutes pre TMS and 5 minutes post TMS
The Emotion Conflict Resolution Task is a behavioral task requiring correct identification of an emotion word overlayed on photographs of facial expressions of emotion. Outcome measure 4: Slope of reaction time during trials when the image is of a happy facial expression but the word is "Fear" (incongruent)
次要结局
未报告次要终点
研究者
Kristen K. Ellard, Ph.D.
Instructor in Psychology
Massachusetts General Hospital