Investigating the Use of Complex Pulse Shapes for DBS in Movement Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Stage 1: Therapeutic window = Amplitude at which therapeutic benefit is obtained versus amplitude at which side-effects occur, both expressed in mA (milliamperes).
研究概览
简要总结
Parkinson's disease and essential tremor are chronic movement disorders for which there is no cure. When medication is no longer effective, deep brain stimulation (DBS) is recommended. Standard DBS is a neuromodulation method that uses a simple monophasic pulse, delivered from an electrode to stimulate neurons in a target brain area. This monophasic pulse spreads out from the electrode creating a broad, electric field that stimulates a large neural population. This can often effectively reduce motor symptoms. However, many DBS patients experience side effects - caused by stimulation of non-target neurons - and suboptimal symptom control - caused by inadequate stimulation of the correct neural target. The ability to carefully manipulate the stimulating electric field to target specific neural subpopulations could solve these problems and improve patient outcomes. The use of complex pulse shapes, specifically biphasic pulses and asymmetric pre-pulses, can control the temporal properties of the stimulation field. Evidence suggests that temporal manipulations of the stimulation field can exploit biophysical differences in neurons to target specific subpopulations. Therefore, our aim is to evaluate the effectiveness of complex pulse shapes to reduce side effects and improve symptom control in DBS movement patients.
详细描述
The study had three stages. In the first stage, a wide range of investigatory pulse shapes in a small number of patients. The effect of the pulses on the therapeutic window will be assessed.
Stage 2 will perform a short-term chronic evaluation in a larger number of patients of the complex pulse shape selected as most interesting from stage 1.
- ET patients will first be assessed after 3 hours of the cathodic or complex pulse (double-blind design).
- PD patients will only be assessed after 1 week of each pulse.
Stage 3 will then focus on long-term evaluation (upto 2 years). Outcomes: see stage 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double-blinded design
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-op the implanted electrodes pass an integrity check, i.e. no open or shorted electrodes.
- •Stable medications
- •Lack of dementia or depression.
- •Patient is willing and able to comply with all visits and study related procedures
- •Patient understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
- •Patient can tolerate at least 12 hours OFF medication and per clinical judgement be able to perform all study related procedures
排除标准
- •Any significant psychiatric problems, including unrelated clinically significant depression.
- •Any current drug or alcohol abuse.
- •Any history of recurrent or unprovoked seizures.
- •Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months.
结局指标
主要结局
Stage 1: Therapeutic window = Amplitude at which therapeutic benefit is obtained versus amplitude at which side-effects occur, both expressed in mA (milliamperes).
时间窗: Immediately after testing
Amplitude at which therapeutic benefit is obtained versus amplitude at which side-effects occur, both expressed in mA (milliamperes).
Stage 2 ET (3 hours): ataxia scores
时间窗: Measured after 3 hours of stimulation
ICARS (International cooperative ataxia rating scale): total score. Max 100 (higher score for more ataxia).
Stage 2 ET (1 week): number of treatment-related adverse events as assessed by CTCAE v4.0
时间窗: During 1 week of stimulation
Follow-up of (S)AE related to the study during that week
Stage 2 PD (1 week): number of treatment-related adverse events as assessed by CTCAE v4.0
时间窗: During 1 week of stimulation
Follow-up of (S)AE related to the study during that week
Stage 3 ET (2 years): number of treatment-related adverse events as assessed by CTCAE v4.0
时间窗: During 2 years of stimulation
Follow-up of (S)AE related to the study during those 2 years
Stage 2 ET (3 hours): tremor scores
时间窗: Measured after 3 hours of stimulation
FTM (Fahn-Tolosa-Marin) total score. Max 116 (higher score for more tremor).
次要结局
- Stage 2 ET (1 week): tremor measured with Kinesia One wearable(Measured after 1 week of stimulation)
- Stage 2 PD (1 week): assessment motor symptoms in Parkinson's(Measured after 1 week of stimulation)
- Stage 1: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Upto one week after the study visit of stage 1)
- Stage 2 ET (3 hours): ataxia subscores(Measured at 1 hours, 2 hours and 3 hours after start of stimulation)
- Stage 2 ET (1 week): cognition(Measured after 1 week of stimulation)
- Stage 2 ET (3 hours): tremor subscores(Measured at 1 hours, 2 hours and 3 hours after start of stimulation)
- Stage 2 ET (3 hours): speech assessment (least dysarthria)(Measured at 1 hours, 2 hours and 3 hours after start of stimulation)
- Stage 2 ET (1 week): ataxia subscores and total score(Measured after 1 week of stimulation)
- Stage 2 ET (1 week): tremor time measured with Kinesia 360(Measured during 1 week of stimulation)
- Stage 2 PD (1 week): assessment non-motor symptoms in Parkinson's(Measured after 1 week of stimulation)
- Stage 2 ET (1 week): tremor scores and subscores(Measured after 1 week of stimulation)
- Stage 2 ET (1 week): quality-of-life(Measured once daily during 1 week of stimulation)
- Stage 2 PD (1 week): assessment motor symptoms in Parkinson's with Kinesia 360 wearable(Measured after 1 week of stimulation)
- Stage 2 ET (3 hours): Therapeutic window: Amplitude to elicit tremor arrest, amplitude to elicit ataxia, amplitude to elicit stim-induced side-effects(Immediately after testing)
- Stage 2 ET (1 week): speech assessment (least dysarthria)(Measured after 1 week of stimulation)
- Stage 2 PD (1 week): therapeutic window (amplitude at loss of rigidity and amplitude at stim-induced side-effects)(Immediately after testing)
- Stage 2 PD (1 week): assessment of motor symptoms in Parkinson's with Kinesia One wearable(Measured after 1 week of stimulation)
- Stage 2 PD (1 week): assessment of speech (least dysarthria)(Measured after 1 week of stimulation)
- Stage 2 PD (1 week): cognition(Measured after 1 week of stimulation)
- Stage 2 PD (1 week): quality-of-life(Measured once daily during 1 week of stimulation)