A Phase 2 interventional study of Menthol gloves and socks and Placebo gloves and socks in Parkinson's Disease, sponsored by Taipei Medical University Hospital. Not yet recruiting at 1 site in Taiwan. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Taipei Medical University Hospital · Phase 2, Interventional, and Supportive care
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.
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 80 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Taipei Medical University Hospital is the lead sponsor of 64 studies on the registry; 12 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will wear gloves and socks containing menthol daily for four weeks.
Drug: Menthol gloves and socks
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.
Drug: Placebo gloves and socks
Participants will wear menthol-containing gloves and socks for five minutes per day, five days a week, over a four-week period.
Participants will wear gloves and socks with plain lotion for five minutes per day, five days a week, over a four-week period.
Unified Parkinson's Disease Rating Scale (UPDRS) I,II,III
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.
Time frame: Evaluations will be conducted at the time of randomization and will serve as baseline data.
Unified Parkinson's Disease Rating Scale (UPDRS) I,II,III
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.
Time frame: Evaluations will be conducted at the fourth week after the start of the intervention.
Unified Parkinson's Disease Rating Scale (UPDRS) I,II,III
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.
Time frame: Evaluations will be conducted at the fourth week after the end of the intervention, i.e. the eighth week after start of intervention.
Pittsburgh Sleep Quality Index (PSQI)
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.
Time frame: Evaluations will be conducted at the time of randomization and will serve as baseline data.
Pittsburgh Sleep Quality Index (PSQI)
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.
Time frame: Evaluations will be conducted at the fourth week after the start of the intervention.
Pittsburgh Sleep Quality Index (PSQI)
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.
Time frame: 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 Sleep Scale-2 (PDSS-2)
The PDSS-2 is a self-reported tool designed to assess sleep disturbances specifically in individuals with Parkinson's disease. It includes 15 items covering various sleep-related issues such as sleep onset, duration, nocturnal motor symptoms, and daytime sleepiness.
Time frame: Evaluations will be conducted at the time of randomization and will serve as baseline data.
Parkinson's Disease Sleep Scale-2 (PDSS-2)
The PDSS-2 is a self-reported tool designed to assess sleep disturbances specifically in individuals with Parkinson's disease. It includes 15 items covering various sleep-related issues such as sleep onset, duration, nocturnal motor symptoms, and daytime sleepiness.
Time frame: Evaluations will be conducted at the fourth week after the start of the intervention.
Parkinson's Disease Sleep Scale-2 (PDSS-2)
The PDSS-2 is a self-reported tool designed to assess sleep disturbances specifically in individuals with Parkinson's disease. It includes 15 items covering various sleep-related issues such as sleep onset, duration, nocturnal motor symptoms, and daytime sleepiness.
Time frame: 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)
The PDQ-39 is a 39-item self-report questionnaire designed to assess health-related quality of life in people with Parkinson's disease. It covers 8 domains: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and sleep.
Time frame: Evaluations will be conducted at the time of randomization and will serve as baseline data.
Parkinson's Disease Questionnaire (PDQ-39)
The PDQ-39 is a 39-item self-report questionnaire designed to assess health-related quality of life in people with Parkinson's disease. It covers 8 domains: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and sleep.
Time frame: Evaluations will be conducted at the fourth week after the start of the intervention.
Parkinson's Disease Questionnaire (PDQ-39)
The PDQ-39 is a 39-item self-report questionnaire designed to assess health-related quality of life in people with Parkinson's disease. It covers 8 domains: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and sleep.
Time frame: Evaluations will be conducted at the fourth week after the end of the intervention, i.e. the eighth week after start of intervention.
Plan to share: No — Data including paper and electronic files will be destroyed after two years since the end of the study. Data obtained from the study, if digitized, will be stored on the investigator's computer in the hospital office and secured the password. Written data will be kept in a locked drawer in the investigator's office and stored separately from the subject's consent form. The data will be kept for five years after the end of the trial, at which time the digital data will be deleted from the computer and the written data will be deleted by shredder.
This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Taipei Medical University Hospital