Effect of Menthol on Motor Deficits and Sleep Disturbances in Patients With Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Unified Parkinson's Disease Rating Scale (UPDRS) I,II,III
研究概览
简要总结
Parkinson's disease (PD) is a progressive neurological disorder characterized by both motor and non-motor symptoms due to the degeneration of dopamine-producing neurons. There is currently no cure. Menthol, a natural compound that activates TRPM8 receptors, has shown neuroprotective and motor function benefits in preclinical PD models. In mice, distal limb immersion in menthol improved dopamine neuron survival and motor performance. Similar menthol-based interventions improved outcomes in a stroke model and a clinical trial with stroke patients. This study investigates whether topical menthol can offer therapeutic benefits for individuals with PD.
详细描述
Parkinson's disease (PD) is a progressive neurological disorder that affects both motor and non-motor functions, with symptoms that can vary widely in severity. It is caused by the degeneration of dopamine-producing neurons in the substantia nigra, a brain region essential for movement control. The characteristic motor symptoms of PD include tremor, rigidity, bradykinesia, and postural instability. In addition to these motor impairments, many individuals with PD also experience non-motor symptoms, such as sleep disturbances, which can significantly impact their quality of life. Unfortunately, there is currently no cure for PD.
Menthol, a naturally occurring compound found in peppermint essential oil, has been shown to activate TRPM8 receptors in somatosensory neurons. Pharmacological activation of peripheral TRPM8 receptors enhances neural activity, which is subsequently transmitted to the brain.
In previous preclinical studies, the investigators used a dopamine toxin-induced PD mouse model and treated the mice with distal limb immersion in menthol. The results of immunohistochemical staining showed that limb immersion in menthol reduced the loss of dopamine neurons and increased the dopamine content in the mouse striatum. The mice's motor function also improved, as indicated by a significant increase in the time they spent running on the rotarod. The investigators also evaluated the effects of menthol in a stroke mouse model induced by MCAO. Topical application of menthol to the paw alleviated acute cerebral infarction and ischemia-induced sensorimotor deficits in MCAO mice.
In our recent clinical trial, the investigators evaluated the effects of menthol-containing gloves and socks in acute ischemic stroke patients. After four weeks of treatment, patients showed improvements in their Modified Rankin Scale (mRS) and Barthel Index (BI) scores, suggesting that this intervention may help enhance functional recovery. Based on these promising results, the investigators hypothesize that a similar approach could benefit individuals with PD.
The investigators aim to conduct a double-blind, randomized controlled trial evaluating the effectiveness of menthol-containing gloves and socks in treating motor deficits and sleep disorders in patients with PD：A total of 80 patients with PD will be randomized into the following groups: (1) menthol-containing gloves and socks (2) placebo. The treatment duration will be 4 weeks, with 4 weeks follow-up. All patients will be clinically assessed at the randomization, 4 and 8 week. Unified Parkinson's Disease Rating Scale (UPDRS) I,II,III, Pittsburgh Sleep Quality Index (PSQI), Parkinson's Disease Sleep Scale-2 (PDSS-2), Parkinson's Disease Questionnaire (PDQ-39) and detailed neurological examination will be included in the assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •aged between 30 and 80 years (inclusive);
- •diagnosed with idiopathic PD based on the Brain Bank criteria of the UK Parkinson's Disease Society less than 3 years;
- •Hoehn and Yahr stages 1-3 and currently receiving treatment; experiencing sleep disorders with a Pittsburgh Sleep Quality Index (PSQI) > 5;
- •has signed the informed consent form approved by the Institutional Review Board and dated accordingly;
- •no changes in PD medications within four weeks prior to participating in this trial, and no dosage changes during the study period;
- •able to use other medications that may affect sleep, except those explicitly prohibited, provided the dosage has been stable for the four weeks before screening and remains unchanged during the study.
排除标准
- •menthol allergy;
- •pregnant and breastfeeding women;
- •diagnosed with secondary and atypical PD;
- •patients with conditions such as uremia, cirrhosis, congestive heart failure with pulmonary edema, coagulation disorders, epilepsy, alcoholism, drug abuse, or
- •deemed unsuitable for participation in this study by the principal investigator.
研究组 & 干预措施
Menthol Group
Participants in this arm will wear gloves and socks containing menthol daily for four weeks.
干预措施: Menthol gloves and socks (Drug)
Placebo Group
Participants in this arm will wear placebo gloves and socks daily for four weeks. These are identical in appearance and material to those used in the treatment group but contain no active menthol compound.
干预措施: Placebo gloves and socks (Drug)
结局指标
主要结局
Unified Parkinson's Disease Rating Scale (UPDRS) I,II,III
时间窗: Evaluations will be conducted at the time of randomization and will serve as baseline data.
The UPDRS is a clinical tool to assess the severity of Parkinson's disease. It consists of: Part I: Mentation, Behavior, and Mood (cognitive and psychiatric symptoms); Part II: Activities of Daily Living (self-reported motor activities); Part III: Motor Examination (clinician-assessed motor symptoms); The combined score of Parts I, II, and III reflects overall disease severity.
Unified Parkinson's Disease Rating Scale (UPDRS) I,II,III
时间窗: Evaluations will be conducted at the fourth week after the start of the intervention.
The UPDRS is a clinical tool to assess the severity of Parkinson's disease. It consists of: Part I: Mentation, Behavior, and Mood (cognitive and psychiatric symptoms); Part II: Activities of Daily Living (self-reported motor activities); Part III: Motor Examination (clinician-assessed motor symptoms); The combined score of Parts I, II, and III reflects overall disease severity.
Pittsburgh Sleep Quality Index (PSQI)
时间窗: Evaluations will be conducted at the time of randomization and will serve as baseline data.
The PSQI is a self-report questionnaire assessing sleep quality and disturbances over the past month. It consists of 19 items across 7 domains: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
Pittsburgh Sleep Quality Index (PSQI)
时间窗: Evaluations will be conducted at the fourth week after the start of the intervention.
The PSQI is a self-report questionnaire assessing sleep quality and disturbances over the past month. It consists of 19 items across 7 domains: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
Unified Parkinson's Disease Rating Scale (UPDRS) I,II,III
时间窗: Evaluations will be conducted at the fourth week after the end of the intervention, i.e. the eighth week after start of intervention.
The UPDRS is a clinical tool to assess the severity of Parkinson's disease. It consists of: Part I: Mentation, Behavior, and Mood (cognitive and psychiatric symptoms); Part II: Activities of Daily Living (self-reported motor activities); Part III: Motor Examination (clinician-assessed motor symptoms); The combined score of Parts I, II, and III reflects overall disease severity.
Pittsburgh Sleep Quality Index (PSQI)
时间窗: Evaluations will be conducted at the fourth week after the end of the intervention, i.e. the eighth week after start of intervention.
The PSQI is a self-report questionnaire assessing sleep quality and disturbances over the past month. It consists of 19 items across 7 domains: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
次要结局
- Parkinson's Disease Sleep Scale-2 (PDSS-2)(Evaluations will be conducted at the time of randomization and will serve as baseline data.)
- Parkinson's Disease Sleep Scale-2 (PDSS-2)(Evaluations will be conducted at the fourth week after the start of the intervention.)
- Parkinson's Disease Questionnaire (PDQ-39)(Evaluations will be conducted at the time of randomization and will serve as baseline data.)
- Parkinson's Disease Questionnaire (PDQ-39)(Evaluations will be conducted at the fourth week after the start of the intervention.)
- Parkinson's Disease Sleep Scale-2 (PDSS-2)(Evaluations will be conducted at the fourth week after the end of the intervention, i.e. the eighth week after start of intervention.)
- Parkinson's Disease Questionnaire (PDQ-39)(Evaluations will be conducted at the fourth week after the end of the intervention, i.e. the eighth week after start of intervention.)