Coordinated Reset Deep Brain Stimulation for Parkinson's Disease
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III
研究概览
简要总结
Deep brain stimulation (DBS) is a surgical implant procedure for the treatment of Parkinson's Disease (PD) utilizing medical devices approved by the FDA. A novel approach to current DBS approaches is called "Coordinated Reset" DBS (CR-DBS) which uses different patterns of stimulation at lower currents and can address the limitations of traditional DBS (T-DBS) that uses continuous high amplitude and high frequency stimulation. This study will evaluate the safety and short-term efficacy of CR-DBS in PD. The results from this study will significantly advance the development of CR-DBS for the treatment of PD. Findings in this study will also provide the rationale for further development of this novel DBS approach for other neurological and psychiatric disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Idiopathic Parkinson's Disease
- •Minimum age of 21 years old
- •Will be or has been implanted with the Boston Scientific Vercise Genus Rechargeable DBS system
排除标准
- •History of musculoskeletal disorders that affect movement of the limbs/gait
- •Other significant neurological disorder
- •Significant psychiatric disorder
- •History of dementia or cognitive impairment that precludes them from getting DBS surgery or per study staff judgment, MacCAT-CR assessment does not deduce that the participant has capacity to consent
- •Other significant medical disorder that could impede study participation
- •Pregnant women
研究组 & 干预措施
CR-DBS
Randomized to either T-DBS occurring first or CR-DBS occurring first (50/50 chance of being assigned to either, but will be assessing both)
干预措施: DBS (Device)
T-DBS
Randomized to either T-DBS occurring first or CR-DBS occurring first (50/50 chance of being assigned to either, but will be assessing both)
干预措施: DBS (Device)
结局指标
主要结局
Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III
时间窗: Through participant study completion, an average of two months
The MDS-UPDRS is a standard rating scale for PD that has been widely used in clinical settings and PD research. It utilizes a 4-subscale structure and 5-point (Normal = 0 to Severe = 4) severity scale. Part III of the Scale assesses the motor signs of PD through 18 items, with a maximum possible score of 72.
次要结局
- Frequency and Severity of Bradykinesia, Dyskinesia, Tremor, Sleep Quality and Fragmentation Scores Measured via KinetiGraph.(Through participant study completion, an average of two months)
- Amplitude Decrement via Rapid Alternating Movements (RAMs)(Through participant study completion, an average of two months)
- Forearm Rigidity(Through participant study completion, an average of two months)
- Cognitive Measurements (TMT-B)(Through participant study completion, an average of two months)
- Verbal Fluency Measurement (DKEFS)(Through participant study completion, an average of two months)
- Working Memory Assessment via N-Back Task(Through participant study completion, an average of two months)
- Dyskinesia Assessment via Rush Dyskinesia Rating Scale (RDRS)(Through participant study completion, an average of two months)
- Frequency of participants with adverse events as assessed by CTCAE v6.0(Through participant study completion, an average of two months)
- Step Length ("Steady-State Gait")(Through participant study completion, an average of two months)
- Gait Speed ("Steady-State Gait")(Through participant study completion, an average of two months)
- Cadence ("Steady-State Gait")(Through participant study completion, an average of two months)
- Step Variability ("Steady-State Gait")(Through participant study completion, an average of two months)
- Step Asymmetry ("Steady-State Gait")(Through participant study completion, an average of two months)
- Swing Time Variability ("Steady-State Gait")(Through participant study completion, an average of two months)
- Frequency of Freezing of Gait ("Steady-State Gait")(Through participant study completion, an average of two months)
- Duration of Freezing of Gait ("Steady-State Gait")(Through participant study completion, an average of two months)
- Difference in Step Length (w/ and w/o 1-Back; "Dual-Task Effect on Gait")(Through participant study completion, an average of two months)
- Difference in Gait Speed (w/ and w/o 1-Back; "Dual-Task Effect on Gait")(Through participant study completion, an average of two months)
- Difference in Cadence (w/ and w/o 1-Back; "Dual-Task Effect on Gait")(Through participant study completion, an average of two months)
- Difference in Step Variability (w/ and w/o 1-Back; "Dual-Task Effect on Gait")(Through participant study completion, an average of two months)
- Difference in Step Asymmetry (w/ and w/o 1-Back; "Dual-Task Effect on Gait")(Through participant study completion, an average of two months)
- Difference in Swing Time Variability (w/ and w/o 1-Back; "Dual-Task Effect on Gait")(Through participant study completion, an average of two months)