NCT04652583已完成2 期
Auricular Muscle Zone Stimulation for Parkinson Disease (Earstim-PD)
Stoparkinson Healthcare Systems LLC16 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2021年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 16
- 主要终点
- Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Score) at 20 minutes
研究概览
简要总结
A Multicenter, Randomized, Blinded, Electronic Device in Subjects with Parkison Disease.
详细描述
This study is a multi-center, prospective, randomized, double-blinded, sham-controlled, within-subject design, 3-treatment, 3-period cross-over study involving 38 subjects with Parkinson's Disease who have the wearing-off phenomenon on oral levodopa therapy. All participants will receive three treatments on different days, each with different stimulation conditions. All subjects will wear the Earstim device on the ear ipsilateral to the side of the body more affected by Parkinson's Disease for 120 minutes during each of the three treatment applications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Subject is a male or female ≥18 years of age.
- •Subject has Parkinson's Disease and is on levodopa therapy.
- •Subject experiences OFF periods with an "ON" score ≥20% better than the OFF score as measured by the MDS-UPDRS motor score (MDS-UPDRS Part III).
- •The subject's daily "OFF" time duration is ≥2 hours per day.
- •The subject's Hoehn-Yahr stage when "OFF" must be less than Stage 4 (i.e., subject must be able to walk without the use of an assisted device, such as a cane or a walker).
- •Subject receives levodopa at least TID with a minimum of 100 mg levodopa administered with each dose.
- •Subject can tolerate 2 hours in an "OFF" period without requiring rescue medication.
- •Subject is willing and able to not change Parkinson's Disease medications or dosages during the up to 2 week study therapy period.
- •Subject is willing to provide Informed Consent to participate in the study.
- •Subject is willing and able to comply with all study procedures and required availability for study visits.
排除标准
- •Subject has a medical or psychiatric comorbidity that can compromise participation in the study.
- •Subject has cognitive dysfunction defined by a Montreal Cognitive Assessment (MoCA) score <
- •Subject has moderate levodopa-induced dyskinesias as indicated by a score >2 on items 4.1 and/or 4.2 in the MDS-UPDRS Part IV.
- •Subject has clinically significant depression as determined by the Beck Depression Inventory-II score >
- •Subject is pregnant as determined by a urine pregnancy test at the screening visit.
- •Subject is of childbearing potential and is not surgically sterilized or does not use a reliable measure of contraception.
- •Subject has a form of Parkinsonism other than Parkinson's Disease, such as Drug-induced Parkinsonism or Multiple System Atrophy.
- •Subject has an implanted deep brain stimulator (DBS).
- •Subject is receiving direct intestinal infusions of levodopa.
- •Subject has epilepsy.
- •Subject medications are anticipated to change during the two (2) week study period (Note: the study requires stable medications during the device testing period).
- •Subject has a cardiac pacemaker or defibrillator, bladder stimulator, spinal cord stimulator or other active electronic medical device.
结局指标
主要结局
Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Score) at 20 minutes
时间窗: Baseline, 20 minutes after the stimulation is initiated
The primary efficacy endpoint is the overall change from baseline to 20 minutes after onset of stimulation in MDS-UPDRS motor score (MDS-UPDRS Part III), comparing the sham arm vs the average 20-minute change of the 20-minute and 60-minute auricular stimulation. Each parkinsonian sign or symptom is rated on a 5-point Likert-type scale (ranging from 0 to 4), with higher scores indicating more severe impairment.
次要结局
- Patient Global Impression of Change (PGIC) scored by the subject prior to stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.(120 minutes after stimulation is initiated.)
- Kinesia-ONE™ Variable: Hand Grasp Amplitude Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.(120 minutes after stimulation is initiated.)
- Area Under Curve(120 minutes after stimulation is initiated.)
- Timed Get Up and Go test prior to stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.(120 minutes after stimulation is initiated.)
- Kinesia-ONE™ Variable: Finger Tapping Amplitude Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.(120 minutes after stimulation is initiated.)
- Kinesia-ONE™ Variable: Rapid Alternating Amplitude Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.(120 minutes after stimulation is initiated.)
- Kinesia-ONE™ Variable: Rest Tremor Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.(120 minutes after stimulation is initiated.)
- Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores comparison between each study arm at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.(120 minutes after stimulation is initiated.)
- Kinesia-ONE™ Variable: Postural Tremor Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.(120 minutes after stimulation is initiated.)
- Kinesia-ONE™ Variable: Rapid Alternating Movement Speed Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.(120 minutes after stimulation is initiated.)
- Maximal improvement in MDS-UPDRS motor score (MDS-UPDRS Part III) from prior to stimulation to any of the follow-up time points up to 120 minutes after onset of stimulation.(120 minutes after stimulation is initiated.)
- Clinical Global Impression of Change (CGIC) prior to stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.(Baseline, 120 minutes after stimulation is initiated.)
- Kinesia-ONE™ Variable: Finger Tapping Speed Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.(120 minutes after stimulation is initiated.)
- Kinesia-ONE™ Variable: Hand Grasp Speed Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.(120 minutes after stimulation is initiated.)
- Kinesia-ONE™ Variable: Dyskinesia Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.(120 minutes after stimulation is initiated.)
- Determination by the investigator of dyskinesia severity by MDS-UPDRS Part IV prior to stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.(120 minutes after stimulation is initiated)
- Change in mood as measured by the Anxiety Mood Score from baseline to 120 minutes after onset of stimulation.(120 minutes after stimulation is initiated.)
- Change in mood as measured by the Depressed Mood Score from baseline to 120 minutes after onset of stimulation.(120 minutes after stimulation is initiated.)
- Change in subjects' sense of well-being as measured by an exploratory ordinal scale prior to stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.(120 minutes after stimulation is initiated.)
- Determination by a consensus between subject and investigator of whether the subject is "OFF" or "ON" prior to stimulation and at the follow-up time points up to 120 minutes after onset of stimulation.(120 minutes after stimulation is initiated.)
研究者
研究点 (16)
Loading locations...
相似试验
已完成
不适用
Effect of Auricular Stimulation on Locomotion in Patients With Parkinson's DiseaseParkinson DiseaseNCT03907007Inventram10
终止
不适用
Transcutaneous Vibro-Acoustic Therapy in Parkinson DiseaseParkinson DiseaseNCT05962476University of Michigan1
招募中
不适用
Effect of Sensory Electrical Stimulation on Resting Tremors in Patients with Parkinson's DiseaseParkinson DiseaseNCT06646510Cairo University30
招募中
1 期
Trial of electrical stimulation therapy for Parkinson's disease patients with postural abnormalitiesParkinson's diseaseJPRN-UMIN000050866Medical Corporation Kayoukai Kawaguchi Neurosurgery Rehabilitation Clinic12
终止
不适用
Evaluation of Using Vibrotactile Coordinated Reset for Management of Parkinson's DiseaseParkinson DiseaseNCT03857867Peter Tass, MD, PhD7