Functional Brain Network Changes in Patients Undergoing Deep Brain Stimulation for Essential Tremor
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- CTCM Coherence
研究概览
简要总结
The purpose of this study is to collect electrophysiological data related to functional brain network changes in patients undergoing deep brain stimulation for the treatment of essential tremor. Participants will either 1) have electroencephalography (EEG) scalp electrodes placed, or 2) remain seated with their head inside of a magnetoencephalography (MEG) recording system, as resting-state and task-related data are acquired. Spontaneous electrophysiological activity will be recorded in both the eyes open and eyes closed conditions with the participant seated comfortably. These recordings will be repeated in the DBS OFF and DBS ON states, with the ON state involving specific settings identified as optimal, sub-optimal, or ineffective at achieving tremor control. They will also be repeated following the optional administration non-DBS tremor mitigation techniques, which may include one or more of the following: 1) cooling the limb, 2) oral administration of alprazolam, 3) oral consumption of ethanol (alcohol), or 4) peripheral nerve stimulation.
详细描述
Electrophysiological data from participants will be collected during electroencephalography (EEG) or magnetoencephalography (MEG) procedures. The EEG or MEG experiments will also include recordings from the DBS system that may be synchronized to externally recorded signals (e.g., MEG, EEG, EMG, accelerometry) via gentle tap-induced motion artifacts, and/or by applying a small, barely perceptible electrical current at the skin over the DBS system with use of a transcutaneous electrical nerve stimulation (TENS) unit.
It is hypothesized that the chronic, electrical stimulation of the target region has both local and circuit-wide effects, the net effect of which is to disrupt the pathophysiological neural activity present across both cortical and subcortical brain regions that and thought to underlie disease manifestation (i.e., tremor). By systemically characterizing the pathways involved in propagating tremor-related activity as well as mediating treatment-related benefits, the investigators hope to identify potential new therapeutic targets or treatment paradigms to further optimize tremor control in this population.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 30 and 80 years of age;
- •Ability to provide informed consent;
- •Clinical diagnosis of ET by a movement disorders neurologist with a disease duration of at least 3 years and being treated with a DBS; OR
- •Clinical diagnosis of ET by a movement disorders neurologist with a disease duration of at least 3 years and not being treated with a DBS; OR
- •No known neurological disease or disorder.
排除标准
- •The individual has a condition that, in the opinion of the investigator, would significantly increase the risk for interference with study compliance, safety, or outcome;
- •Presence of active psychiatric symptoms meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Axis-I disorder on formal psychiatric evaluation other than depression or anxiety;
- •History of cognitive impairment meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for dementia on formal neuropsychological evaluation, as documented in chart;
- •Lack of English-language fluency which would interfere with the ability to understand the study consenting process and potential study risks;
- •Hearing or visual impairment precluding testing;
- •Motor impairment impacting test responses (i.e., orthopedic injury or disease);
- •Anyone currently taking medications with Antabuse-like effects (e.g. Flagyl, Bactrim, Tindamax) will be excluded from any alcohol administration.
研究组 & 干预措施
No Known Neurological Disease or Disorder
- 30-80 years of age
- No known neurological disease or disorder
干预措施: Alcohol (Drug)
Essential Tremor without DBS
- 30-80 years of age
- Diagnosis of ET
- Has not been previously implanted with a DBS system for disease management per standard of care
干预措施: Alcohol (Drug)
Essential Tremor with DBS
- 30-80 years of age
- Diagnosis of ET
- Previously implanted with a DBS system for disease management per standard of care
干预措施: Alcohol (Drug)
No Known Neurological Disease or Disorder
- 30-80 years of age
- No known neurological disease or disorder
干预措施: Cold Therapy (Device)
Essential Tremor with DBS
- 30-80 years of age
- Diagnosis of ET
- Previously implanted with a DBS system for disease management per standard of care
干预措施: Cold Therapy (Device)
Essential Tremor with DBS
- 30-80 years of age
- Diagnosis of ET
- Previously implanted with a DBS system for disease management per standard of care
干预措施: Peripheral Nerve Stimulation (Procedure)
Essential Tremor without DBS
- 30-80 years of age
- Diagnosis of ET
- Has not been previously implanted with a DBS system for disease management per standard of care
干预措施: Cold Therapy (Device)
Essential Tremor without DBS
- 30-80 years of age
- Diagnosis of ET
- Has not been previously implanted with a DBS system for disease management per standard of care
干预措施: Peripheral Nerve Stimulation (Procedure)
No Known Neurological Disease or Disorder
- 30-80 years of age
- No known neurological disease or disorder
干预措施: Peripheral Nerve Stimulation (Procedure)
No Known Neurological Disease or Disorder
- 30-80 years of age
- No known neurological disease or disorder
干预措施: Alprazolam (Drug)
Essential Tremor without DBS
- 30-80 years of age
- Diagnosis of ET
- Has not been previously implanted with a DBS system for disease management per standard of care
干预措施: Alprazolam (Drug)
Essential Tremor with DBS
- 30-80 years of age
- Diagnosis of ET
- Previously implanted with a DBS system for disease management per standard of care
干预措施: Alprazolam (Drug)
结局指标
主要结局
CTCM Coherence
时间窗: up to 8 hours in-lab during experiment
Coherence, a unitless measure of correlation between signals, calculated across the cerebellothalmocorticomuscular (CTCM) circuit, will be computed from neurophysiological recordings including electroencephalography (EEG), electromyography (EMG), magnetoencephalography (MEG), and/or local field potential (LFP), using data collected at rest, during tremor-eliciting tasks, with DBS OFF, with DBS ON (when available), and when using non-DBS tremor interventions (limb cooling and/or peripheral nerve stimulation and/or alprazolam or alcohol).
Power of oscillatory activity across the CTCM network in response to tremor interventions
时间窗: up to 8 hours in-lab during experiment
Power of tremor-related oscillatory activity, in the form of mean power in the 4-12Hz frequency band with units in mV\^2, will be computed from neurophysiological recordings including electroencephalography (EEG), electromyography (EMG), magnetoencephalography (MEG), and/or local field potential (LFP), using data collected at rest, during tremor-eliciting tasks, with DBS OFF, with DBS ON (when available), and when using non-DBS tremor interventions (limb cooling and/or peripheral nerve stimulation and/or alprazolam or alcohol).
次要结局
- Essential tremor severity: Limb acceleration(up to 8 hours in-lab during experiment)
- Essential tremor severity: Tremor Research Group Essential Tremor Rating Scale (TETRAS)(up to 8 hours in-lab during experiment)
- Essential tremor severity: Grip force(up to 8 hours in-lab during experiment)
研究者
James Liao
Principal Investigator
The Cleveland Clinic