The Effects of High-Frequency Repetitive Transcranial Magnetic Stimulation on Impulse Control Disorders in Parkinson's Disease Patients on Dopamine Replacement Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Delay-Discounting
研究概览
简要总结
This study's objective is to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (dlPFC) of patients with Parkinson's Disease (PD) who experience impulse control disorders (ICDs) on impulse control symptoms and cognitive behaviors linked to ICDs: reinforcement learning and delay-discounting. This is a randomized sham-controlled cross-over trial. All patients will undergo a session of active rTMS and a session of sham rTMS, with the order of sessions randomized across participants. Following recruitment and eligibility screening, the eligible participants will undergo two sessions of rTMS (active and sham), immediately followed by neurocognitive tasks and questionnaires, no more than 1-2 weeks apart. Each session will have a duration of approximately 1-1.5 hours.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinician-confirmed diagnosis of PD
- •Ability to provide informed consent, written and verbal
- •Clinician-diagnosed impulse control disorder or impulse control behaviors including punding/hobbyism and dopamine dysregulation syndrome
- •A Beck Depression Inventory (BDI) (Beck et al., 1961) score of 14 or lower
- •A Montreal Cognitive Assessment (MoCA) (Nasreddine et al., 2005) score of 20 or higher
- •On dopamine-replacement therapy
排除标准
- •History of seizures or epilepsy
- •History of brain lesions (such as multiple sclerosis, tumor) reported
- •History of vascular issues in the brain, such as stroke
- •History of a moderate to severe traumatic brain injury
- •Meeting the criteria for a major psychiatric illness such as schizophrenia or depression (BDI score of 14 or higher).
- •Having significant cognitive impairment (assessed by MoCA, cutoff score of 20) (Nasreddine, et al., 2005)
- •Having had TMS done in the recent past (within a year)
- •Pregnancy assessed in female patients
- •Intracranial metallic objects (except for dental fillings)
- •Current use of substances or medications known to significantly reduce seizure threshold.
研究组 & 干预措施
rTMS Active
the participant will receive a type of TMS called repetitive TMS (rTMS) wherein the magnetic pulses delivered will be close together in a rapid sequence over the dlPFC. Participants receive excitatory rTMS with a stimulation frequency of 20 Hz between 100-120% of their resting motor threshold.
干预措施: rTMS Active (Device)
rTMS Sham
Sham rTMS will be the same as real rTMS, except a special sham coil will be used, which produces the same sensation on the scalp of the patients as the real coil but delivers no magnetic stimulation to the brain.
干预措施: rTMS Sham (Device)
结局指标
主要结局
Change in Delay-Discounting
时间窗: Baseline to 1 hour following the intervention
Change in performance on a task assessing delay-discounting. Delay-discounting assesses the participants' impulsivity by requiring them to make choices between smaller sooner hypothetical money rewards and larger later hypothetical money rewards (e.g. $10 today vs $100 in a year). This is a hypothetical choice, and the participant will not be receiving the chosen rewards. A short preliminary version of the task will be completed at the start of the first session (prior to TMS) to optimize task parameters for each participant. The task will be completed on a laptop computer.
Change in Reinforcement Learning
时间窗: Baseline to 1 hour following the intervention
Change in performance on a task assessing reinforcement learning. The reinforcement learning task assesses how well participants learn from rewards vs. punishments. The task will ask participants to choose from two stimuli that predict reward (gaining points) or punishment (losing points) at different rates, which they will learn in the course of the task based on feedback. At the end of the task, participants will be asked to rate how well each stimulus predicted reward or punishment.
次要结局
- Change in impulse control disorder symptoms(Baseline to 1 hour following the intervention)
研究者
Mariya V. Cherkasova
Assistant Professor
West Virginia University