Clinical trial NCT05877079: TRPM8 in Acute Ischemic Stroke by Topical Menthol
Official title: Activation of Peripheral TRPM8 Mitigates Acute Ischemic Stroke by Topically Applied Menthol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ischemic Stroke
Keywords: TRPM8
Menthol
ischemic stroke
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
Collaborators: name: China Medical University, Taiwan
name: Chung Shan Medical University
First posted: 2023-05-26
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: NIHSS
timeFrame: Evaluations will be conducted within seven days of the stroke represented as the baseline data
measure: NIHSS
timeFrame: Evaluations will be conducted at the fourth week after the start of the intervention
measure: NIHSS
timeFrame: 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:
measure: BI
timeFrame: Evaluations will be conducted within seven days of the stroke represented as the baseline data
measure: BI
timeFrame: Evaluations will be conducted at the fourth week after the start of the intervention
measure: BI
timeFrame: Evaluations will be conducted at the fourth week after the end of the intervention, i.e. the eighth week after start of intervention
Other outcomes:
measure: mRS
timeFrame: Evaluations will be conducted within seven days of the stroke represented as the baseline data
measure: mRS
timeFrame: Evaluations will be conducted at the fourth week after the start of the intervention
measure: mRS
timeFrame: Evaluations will be conducted at the fourth week after the end of the intervention, i.e. the eighth week after start of intervention
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: Institute of acupuncture science, College of Chinese Medicine, China Medical University
name: Yi-Hung Chen, PhD
role: STUDY_DIRECTOR
References:
citation: 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.