Ischemic Stroke
Conditions
Keywords
TRPM8, Menthol, ischemic stroke
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.
Interventions
DRUGMenthol
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.
DRUGPlacebo
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.
Sponsors
China Medical University, Taiwan
Chung Shan Medical University
Taipei Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Taiwan
Outcome results
None listed