TRPM8 in Acute Ischemic Stroke by Topical Menthol

Sponsor

Taipei Medical University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05877079

Collaborator

China Medical University, Taiwan (Other), Chung Shan Medical University (Other)

Enrollment

Arms

12.4

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Our previous results suggested that activation of peripheral TRPM8 expressed in the derma tissue of limbs with sufficient concentration of menthol is beneficial to stroke recovery.

In the present study, sixty patients with acute ischemic stroke were randomly divided into two groups: thirty in the treatment group and thirty in the control group. The treatment group will use an emulsion containing 8% w/w menthol, with an average of 80 grams placed inside hand and foot wraps (20 grams in each hand or foot wrap). The control group, on the other hand, will use an emulsion that does not contain any menthol, with an average of 80 grams placed inside hand and foot wraps. Participants in this study will initially undergo a detailed regular neurological examination, an assessment with the National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI) for daily living functions, and the Modified Rankin Scale (mRS) for disability. All participants will be re-evaluated after the fourth and eighth weeks of the trial, with assessments including neurological examination, NIHSS, BI, and mRS.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke	Drug: Menthol Drug: Placebo	Phase 4

Detailed Description

Sixty patients with acute ischemic stroke were randomly divided into two groups: thirty in the treatment group and thirty in the control group.

Participants in this study will initially undergo a detailed regular neurological examination, an assessment with the National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI) for daily living functions, and the Modified Rankin Scale (mRS) for disability. After completing the basic assessments and signing the informed consent, participants will be randomly allocated to either the treatment group or the control group for the trial.

The treatment group will use an emulsion containing 8% w/w menthol, with an average of 80 grams placed inside hand and foot wraps (20 grams in each hand or foot wrap). Participants will wear the wraps for five minutes before removal. This process will be done once a day for five consecutive days in a week, followed by two days of rest, and will last for four weeks.

The control group, on the other hand, will use an emulsion that does not contain any menthol, with an average of 80 grams placed inside hand and foot wraps. The same procedure will be followed: participants will wear the wraps for five minutes before removal, once a day for five consecutive days in a week, followed by two days of rest, for a total of four weeks.

All participants will be re-evaluated after the fourth and eighth weeks of the trial, with assessments including neurological examination, NIHSS, BI, and mRS.

Emergency, neurology outpatient, and inpatient participants will also use the 8% w/w menthol emulsion, with an average of 80 grams placed inside hand and foot wraps (20 grams each). The same procedure will be followed: wearing the wraps for five minutes before removal, once a day for five consecutive days per week, followed by two days of rest, for a total of four weeks.

Participants will be evaluated within seven days after being diagnosed with a stroke, and then again after the fourth and eighth weeks of treatment. The evaluations will include neurological examination, NIHSS, BI, and mRS assessments.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Activation of Peripheral TRPM8 Mitigates Acute Ischemic Stroke by Topically Applied Menthol

Anticipated Study Start Date :

May 20, 2023

Anticipated Primary Completion Date :

May 31, 2024

Anticipated Study Completion Date :

May 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Menthol group Hand and foot wraps with 8% w/w menthol lotion (20 grams each) will be delivered to each subject to wear for 5 min 5 days per week. The total duration is 4 weeks.	Drug: Menthol Patients will wear hand and foot wraps with 8% w/w menthol lotion (20 grams each) for 5 min. Patients will wear the wraps for 5 days per week. The total duration is 4 weeks.
Placebo Comparator: Non-Menthol group Hand and foot wraps containing the lotion (20 grams each) without menthol will be delivered to each subject to wear for 5 min 5 days per week. The total duration is 4 weeks.	Drug: Placebo Patients will wear hand and foot wraps with lotion without menthol (20 grams each) for 5 min. Patients will wear the wraps for 5 days per week. The total duration is 4 weeks.

Arm

Intervention/Treatment

Experimental: Menthol group

Hand and foot wraps with 8% w/w menthol lotion (20 grams each) will be delivered to each subject to wear for 5 min 5 days per week. The total duration is 4 weeks.

Drug: Menthol

Patients will wear hand and foot wraps with 8% w/w menthol lotion (20 grams each) for 5 min. Patients will wear the wraps for 5 days per week. The total duration is 4 weeks.

Placebo Comparator: Non-Menthol group

Hand and foot wraps containing the lotion (20 grams each) without menthol will be delivered to each subject to wear for 5 min 5 days per week. The total duration is 4 weeks.

Drug: Placebo

Patients will wear hand and foot wraps with lotion without menthol (20 grams each) for 5 min. Patients will wear the wraps for 5 days per week. The total duration is 4 weeks.

Outcome Measures

Primary Outcome Measures

NIHSS [Evaluations will be conducted within seven days of the stroke represented as the baseline data]
The National Institutes of Health Stroke Scale:a tool used by healthcare providers to objectively quantify the impairment caused by a stroke and aid planning post-acute care disposition, though was intended to assess differences in interventions in clinical trials.
NIHSS [Evaluations will be conducted at the fourth week after the start of the intervention]
The National Institutes of Health Stroke Scale:a tool used by healthcare providers to objectively quantify the impairment caused by a stroke and aid planning post-acute care disposition, though was intended to assess differences in interventions in clinical trials.
NIHSS [Evaluations will be conducted at the fourth week after the end of the intervention, i.e. the eighth week after start of intervention]
The National Institutes of Health Stroke Scale:a tool used by healthcare providers to objectively quantify the impairment caused by a stroke and aid planning post-acute care disposition, though was intended to assess differences in interventions in clinical trials.

Secondary Outcome Measures

BI [Evaluations will be conducted within seven days of the stroke represented as the baseline data]
Barthel Index:It is an assessment scale used by the medical team to evaluate the patient's functional capacity in daily living. The scale is used to determine what medical care the patient needs and whether the patient is eligible for expatriate care. Lower scores on the scale indicate a patient's lack of independence.
BI [Evaluations will be conducted at the fourth week after the start of the intervention]
Barthel Index:It is an assessment scale used by the medical team to evaluate the patient's functional capacity in daily living. The scale is used to determine what medical care the patient needs and whether the patient is eligible for expatriate care. Lower scores on the scale indicate a patient's lack of independence.
BI [Evaluations will be conducted at the fourth week after the end of the intervention, i.e. the eighth week after start of intervention]
Barthel Index:It is an assessment scale used by the medical team to evaluate the patient's functional capacity in daily living. The scale is used to determine what medical care the patient needs and whether the patient is eligible for expatriate care. Lower scores on the scale indicate a patient's lack of independence.

Other Outcome Measures

mRS [Evaluations will be conducted within seven days of the stroke represented as the baseline data]
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
mRS [Evaluations will be conducted at the fourth week after the start of the intervention]
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
mRS [Evaluations will be conducted at the fourth week after the end of the intervention, i.e. the eighth week after start of intervention]
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Acute ischemic stroke patients, stroke time within one week, those who are legally of age at the time of signing the consent form, NIHSS 4-20, patients who can cooperate with treatment, Self or agent agrees to sign the consent form.

Exclusion Criteria:

NIHSS score does not meet, mRS=5, patients who cannot cooperate, moderate to severe brain trauma, pregnant women, uremia, liver cirrhosis, heart failure with pulmonary edema and coagulation dysfunction, epilepsy, alcohol, drug abuse. Participants were ranked by the investigator as unsuitable for the study.