Menthol for Improving Movement and Sleep in Parkinson's Disease Patients
ConditionParkinson's Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age30-80
SponsorTaipei Medical University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Menthol gloves and socks
DrugParticipants will wear menthol-containing gloves and socks for five minutes per day, five days a week, over a four-week period.
Placebo gloves and socks
DrugParticipants will wear gloves and socks with plain lotion for five minutes per day, five days a week, over a four-week period.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Menthol GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.2
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.3
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.4
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.Secondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Taipei Medical University Hospital
Lead sponsor
China Medical University, Taiwan
Collaborator
Source ClinicalTrials.gov
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