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

NCT07294469 | Not Yet Recruiting Phase 2

• 1 other identifier: N202505079
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease

Keywords

Menthol; Parkinson's Disease; Motor Deficits; Sleep Disturbances

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Evaluations will be conducted at the fourth week after the end of the intervention, i.e. the eighth week after start of intervention.

Secondary Outcomes (6)

• 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 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 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.

Study Arms (2)

Menthol Group

EXPERIMENTAL

Participants in this arm will wear gloves and socks containing menthol daily for four weeks.

Drug: Menthol gloves and socks

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Menthol gloves and socks DRUG

Participants will wear menthol-containing gloves and socks for five minutes per day, five days a week, over a four-week period.

Menthol Group

Placebo gloves and socks DRUG

Participants will wear gloves and socks with plain lotion for five minutes per day, five days a week, over a four-week period.

Placebo Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University Hospital: lead
• China Medical University, Taiwan: collaborator

Study Sites (1)

Taipei Medical University Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Huang SS, Su HH, Chien SY, Chung HY, Luo ST, Chu YT, Wang YH, MacDonald IJ, Lee HH, Chen YH. Activation of peripheral TRPM8 mitigates ischemic stroke by topically applied menthol. J Neuroinflammation. 2022 Jul 27;19(1):192. doi: 10.1186/s12974-022-02553-4.

  PMID: 35897101 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Neurologic Manifestations; Parasomnias

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Mental Disorders

Study Officials

• Yi-Hung Chen, PhD

  International Master Program in Integrative Health, College of Chinese Medicine, China Medical University

  STUDY DIRECTOR

Central Study Contacts

Hsun-Hua Lee, MD-PhD

CONTACT

(886)02-27372181; kaorulei@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: January 8, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)