Menthol for Improving Movement and Sleep in Parkinson's Disease Patients

January 5, 2026 updated by: Taipei Medical University Hospital

Effect of Menthol on Motor Deficits and Sleep Disturbances in Patients With Parkinson's Disease

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Taipei Medical University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. aged between 30 and 80 years (inclusive);
  2. diagnosed with idiopathic PD based on the Brain Bank criteria of the UK Parkinson's Disease Society less than 3 years;
  3. Hoehn and Yahr stages 1-3 and currently receiving treatment; experiencing sleep disorders with a Pittsburgh Sleep Quality Index (PSQI) > 5;
  4. has signed the informed consent form approved by the Institutional Review Board and dated accordingly;
  5. no changes in PD medications within four weeks prior to participating in this trial, and no dosage changes during the study period;
  6. 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.

Exclusion Criteria:

  1. menthol allergy;
  2. pregnant and breastfeeding women;
  3. diagnosed with secondary and atypical PD;
  4. patients with conditions such as uremia, cirrhosis, congestive heart failure with pulmonary edema, coagulation disorders, epilepsy, alcoholism, drug abuse, or
  5. deemed unsuitable for participation in this study by the principal investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Menthol Group
Participants in this arm will wear gloves and socks containing menthol daily for four weeks.
Drug: Menthol 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.
Placebo Comparator: 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.
Drug: Placebo gloves and socks
Participants will wear gloves and socks with plain lotion for five minutes per day, five days a week, over a four-week period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unified Parkinson's Disease Rating Scale (UPDRS) I,II,III
Time Frame: 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.
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
Time Frame: 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.
Evaluations will be conducted at the fourth week after the start of the intervention.
Unified Parkinson's Disease Rating Scale (UPDRS) I,II,III
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.

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.
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)
Time Frame: 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.
Evaluations will be conducted at the time of randomization and will serve as baseline data.
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 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.
Evaluations will be conducted at the fourth week after the start of the intervention.
Pittsburgh Sleep Quality Index (PSQI)
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.
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.
Evaluations will be conducted at the fourth week after the end of the intervention, i.e. the eighth week after start of intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parkinson's Disease Sleep Scale-2 (PDSS-2)
Time Frame: Evaluations will be conducted at the time of randomization and will serve as baseline data.
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.
Evaluations will be conducted at the time of randomization and will serve as baseline data.
Parkinson's Disease Sleep Scale-2 (PDSS-2)
Time Frame: Evaluations will be conducted at the fourth week after the start of the intervention.
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.
Evaluations will be conducted at the fourth week after the start of the intervention.
Parkinson's Disease Sleep Scale-2 (PDSS-2)
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.
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.
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)
Time Frame: Evaluations will be conducted at the time of randomization and will serve as baseline data.
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.
Evaluations will be conducted at the time of randomization and will serve as baseline data.
Parkinson's Disease Questionnaire (PDQ-39)
Time Frame: Evaluations will be conducted at the fourth week after the start of the intervention.
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.
Evaluations will be conducted at the fourth week after the start of the intervention.
Parkinson's Disease Questionnaire (PDQ-39)
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.
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.
Evaluations will be conducted at the fourth week after the end of the intervention, i.e. the eighth week after start of intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University Hospital

Collaborators

China Medical University, Taiwan

Investigators

  • Study Director: Yi-Hung Chen, PhD, International Master Program in Integrative Health, College of Chinese Medicine, China Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 15, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

December 8, 2025

First Submitted That Met QC Criteria

December 8, 2025

First Posted (Estimated)

December 19, 2025

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N202505079

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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