TRPM8 in Acute Ischemic Stroke by Topical Menthol

NCT05877079 | Completed Phase 2

• 1 other identifier: N202302006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

TRPM8; Menthol; ischemic stroke

Outcome Measures

Primary Outcomes (3)

• NIHSS

  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.

  Evaluations will be conducted within seven days of the stroke represented as the baseline data

• NIHSS

  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.

  Evaluations will be conducted at the fourth week after the start of the intervention

• NIHSS

  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.

  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 (3)

• BI

  Evaluations will be conducted within seven days of the stroke represented as the baseline data

• BI

  Evaluations will be conducted at the fourth week after the start of the intervention

• BI

  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 (3)

• mRS

  Evaluations will be conducted within seven days of the stroke represented as the baseline data

• mRS

  Evaluations will be conducted at the fourth week after the start of the intervention

• mRS

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

Study Arms (2)

Menthol group

EXPERIMENTAL

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

Non-Menthol group

PLACEBO COMPARATOR

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

Interventions

Menthol 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.

Menthol group

Placebo 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.

Non-Menthol group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Ischemic Stroke

Interventions

Menthol

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Monoterpenes; Terpenes; Lipids

Study Officials

• Yi-Hung Chen, PhD

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

  STUDY DIRECTOR

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: May 14, 2023
• First Posted: May 26, 2023
• Study Start: May 26, 2023
• Primary Completion: June 3, 2024
• Study Completion: June 6, 2024
• Last Updated: October 15, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)