TRPM8 in Acute Ischemic Stroke by Topical Menthol

NCT ID: NCT05877079

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-26
• Study Completion Date: 2024-06-06

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.

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Menthol

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University, Taiwan

OTHER

Sponsor Role: collaborator

Chung Shan Medical University

OTHER

Sponsor Role: collaborator

Taipei Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi-Hung Chen, PhD

Role: STUDY_DIRECTOR

Institute of acupuncture science, College of Chinese Medicine, China Medical University

Locations

Taipei Medical University Hospital

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 35897101 (View on PubMed)

Other Identifiers

N202302006

Identifier Type: -

Identifier Source: org_study_id