Clinical trial NCT06967909: Effectiveness of Tai Chi and Acupuncture on Migraine Attack Prevention and Brain White Matter Changes: A Non-Inferiority RCT
Official title: Effectiveness of Tai Chi and Acupuncture in the Prophylaxes of Episodic Migraine in Hong Kong Chinese Women and the Analysis of Microstructural White Matter Alterations: a Non-inferiority Single-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Migraine
Migraine Disorder
Keywords: Migraine
Tai Chi
Acupuncture
Women
Prophylaxis
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to determine the effectiveness of Tai Chi training and acupuncture on the migraine attacks and structural brain changes in women with episodic migraine.

Researchers will compare Tai Chi training to acupuncture treatment in a randomized controlled trial with 132 female participants. Participants will:

* Be randomly assigned to either the Tai Chi group or the acupuncture group.
* Undergo a 24-week intervention, with structured sessions for Tai Chi or scheduled acupuncture treatments.
* Complete assessments through migraine diaries, questionnaires, physical measurements, MRI and TCD scans at various time points.

The study ensures participant safety through close monitoring, with medical support available in case of discomfort. Data confidentiality will be maintained, with encrypted storage and restricted access for research purposes.

Detailed description: The goal of this clinical trial is to determine whether Tai Chi training has the similar effectiveness in reducing the frequency of migraine attacks as acupuncture; and whether both Tai Chi and acupuncture can improve structural brain changes in women with episodic migraine. It also aims to examine whether the improvements in migraine features are linked to the structural brain changes and better cerebrovascular function after the intervention.

This study is a randomized controlled trial with 132 women who have episodic migraines. Participants will be randomly assigned to either the Tai Chi training group or the acupuncture treatment group, with 66 individuals in each group.

Participants will:

* receive a 24-week intervention, which the Tai Chi group attends instructor-led training sessions and self-practice sessions, and the acupuncture group receives 30 treatment sessions over the same period.
* Undergo assessments, including migraine diaries for migraine features and symptoms; migraine characteristics, lifestyle factors, body measurements (e.g., height, weight, and body composition), and advanced imaging techniques including MRI and TCD scans.
* Data will be collected at baseline, the 12th week, and the 24th week. MRI will be used to assess white matter changes, while TCD will be used to evaluate cerebrovascular function. Both procedures are safe and non-invasive, with specific pre-exam precautions.

To ensure participant safety, Tai Chi sessions will be closely monitored for any adverse effects such as dizziness or falls, while acupuncture treatments will be supervised to address any discomfort. If participants experience intolerable migraines, they will receive guided medication management.

Confidentiality will be strictly maintained, with encrypted data storage and restricted access for research auditing. Personal identifiers will not be linked to the data, and all records will be securely stored for five years before being destroyed.

Eligibility criteria: Inclusion Criteria:

* Chinese women aged 18 years and above;
* Diagnosed with episodic migraines, with or without aura, according to the International Classification of Headache Disorders, 3rd edition (ICHD-3);
* Migraine attack frequency ranging from 2 to 14 days per month (≥15 days/month is classified as chronic migraine and is not included in this study);
* Assessed by a sports specialist as capable of engaging in moderate physical activity;
* Residing in Hong Kong.

Exclusion Criteria:

* Unable to engage in moderate physical activity;
* Comorbid with other neurological disorders;
* Experiencing non-migraine headaches for more than 5 days per month;
* Previous practice of Tai Chi or other mind-body exercises (such as yoga, biofeedback, meditation, etc.);
* Received alternative treatments for migraines (such as acupuncture or Chinese medicine) during the recruitment period or within the past 12 weeks;
* Undergoing preventive medication treatment for migraines during the recruitment period or within the past 12 weeks;
* Excessive use of medication, taking antipsychotic or antidepressant drugs, or using analgesics for other chronic pain conditions for more than 3 days per month within the past 12 weeks;
* Diagnosed with epilepsy or having a mental illness;
* Pregnant, breastfeeding, or currently taking contraceptive medication.

Primary outcomes:
measure: The difference in frequency of migraine attacks
timeFrame: Between 4 weeks before randomization and weeks 9-12 / 21-24 after randomization
measure: The difference in migraine days
timeFrame: Between 4 weeks before randomization and weeks 9-12 / 21-24 after randomization
measure: The difference of white matter abnormalities (WMAs)
timeFrame: From the baseline to 24 weeks
Secondary outcomes:
measure: The proportion of responders
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: The intensity of the headache
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: The duration of headache
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: Migraine related disability
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: Stress level
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: Sleep quality
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: Fatigue level
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: Health related Quality-of-Life
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: Weight
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: Height
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: Waist circumference
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: Hip circumference
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: Percent body fat
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: The difference of pulsatility index (PI)
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: The difference of mean blood flow velocity (MBFV)
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: The difference of impaired cerebrovascular responsiveness (CVR)
timeFrame: From the baseline to 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Hung Hom
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Yao Jie Xie, PhD
role: PRINCIPAL_INVESTIGATOR
References: