- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04664088
Acupuncture for Prophylaxis of Vestibular Migraine
The Efficacy and Safety of Acupuncture for Prophylaxis of Vestibular Migraine
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tianye Hu, MM
- Phone Number: 86-18357046386
- Email: tianye_hty@gmail.com
Study Locations
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-
Zhejiang
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Jiaxing, Zhejiang, China, 314000
- The First Affiliated Hospital of Jiaxing University
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Contact:
- Tianye Hu, MM
- Phone Number: 86-18357048386
- Email: tianye_hty@gmail.com
-
Contact:
- Jin Hu, MM
- Phone Number: 86-13819347974
- Email: leihendieyu@sina.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with age 18 to 80 , male or female;
- Patients meet the criteria proposed by the collaboration of Barany Society and the International Headache Society in 2012;
- Vertigo/migraine attacks at least 3 times per month in the last 3 months; or vertigo/migraine days are at least 4 days per month;
- Patients have unsatisfactory response to rescue treatments and seek for preventive treatments;
- Patients can fully understand the study protocol and agree to sign written informed consent forms.
Exclusion Criteria:
- Patients'vertigo and headache are caused by other diseases, such as vestibular neuritis, Meniere disease, tension headache, and other cerebrovascular diseases.
- Patients have prophylactic headache treatment with drugs in the past 3 months.
- Patients are receiving adjunctive therapy that is not widely accepted for treating VM, such as Chinese herbs.
- Patients have severe complications in cardiovascular, cerebrovascular, liver, kidney, hematopoietic and other systems that are not controlled significantly;
- Pregnant and lactating female patients;
- Patients have mental illness that affects cognitive function.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acupuncture group
Patients in this group will receive acupuncture once every other day (3 days per week) over an 8-week period (a total of 24 sessions).
|
Patients in this group will receive acupuncture once every other day (3 days per week) over an 8-week period (a total of 24 sessions). In each session, needles will be retained for 30 minutes. The acupoints will include Baihui (DU20), Qianding (DU21), Houding (DU19), Yintang (DU29), Fengchi (GB20), Shuaigu (GB8), Tongli (HT5), Hegu (LI4), Taichong (LR3), Fenglong (ST40), Xuanzhong (GB39) and Zulinqi (GB41). The selection of acupoints is on the basis of meridian theory and patients' clinical symptoms. Patients are not allowed to take prophylactic medications. But in case of intolerable acute VM attacks, the patients will be instructed to take triptans as rescue medication, and the dosage of medication will be documented in the patient diary. |
Active Comparator: Medication group
Participants in this group will receive oral administration of venlafaxine 50 mg once a day for 8 weeks.
|
Participants in this group will receive oral administration of venlafaxine 50 mg once a day for 8 weeks.
In case of intolerable acute VM attacks, the patients will be instructed to take triptans as rescue medication, and the dosage of medication will be documented.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the number of vertigo/migraine days and vertigo/migraine attacks
Time Frame: 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
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The number of vertigo/migraine days and vertigo/migraine attacks will be assessed by a patient diary.
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4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
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Change in vertigo severity
Time Frame: 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
|
Vertigo severity will be measured by dizziness handicap inventory (DHI)
|
4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
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Change in migraine intensity
Time Frame: 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
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Migraine intensity will be measured by visual analogue scale (VAS)
|
4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in doses of rescue medication
Time Frame: 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
|
Doses of rescue medication (triptans) will be documented by patients in the patient diary.
|
4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
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Change in anxiety level
Time Frame: 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
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Anxiety level will be measured by Generalized Anxiety Disorder-7 (GAD-7) scale.
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4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
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Change in depression level
Time Frame: 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
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Depression level will be measured by Patient Health Questionnaire (PHQ-9) scale
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4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
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Change in quality of life
Time Frame: 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
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Quality of life will be measure by 36-item short form health survey (SF-36).
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4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
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Collaborators and Investigators
Investigators
- Principal Investigator: Tianye Hu, MM, First Affiliated Hospital of Jiaxing University
Publications and helpful links
General Publications
- Beh SC. Vestibular Migraine: How to Sort it Out and What to Do About it. J Neuroophthalmol. 2019 Jun;39(2):208-219. doi: 10.1097/WNO.0000000000000791.
- Bednarczuk NF, Bonsu A, Ortega MC, Fluri AS, Chan J, Rust H, de Melo F, Sharif M, Seemungal BM, Golding JF, Kaski D, Bronstein AM, Arshad Q. Abnormal visuo-vestibular interactions in vestibular migraine: a cross sectional study. Brain. 2019 Mar 1;142(3):606-616. doi: 10.1093/brain/awy355.
- Tedeschi G, Russo A, Conte F, Laura M, Tessitore A. Vestibular migraine pathophysiology: insights from structural and functional neuroimaging. Neurol Sci. 2015 May;36 Suppl 1:37-40. doi: 10.1007/s10072-015-2161-x.
- Morganti LO, Salmito MC, Duarte JA, Bezerra KC, Simoes JC, Gananca FF. Vestibular migraine: clinical and epidemiological aspects. Braz J Otorhinolaryngol. 2016 Jul-Aug;82(4):397-402. doi: 10.1016/j.bjorl.2015.06.003. Epub 2015 Oct 29.
- Nowaczewska M. Vestibular migraine - an underdiagnosed cause of vertigo. Diagnosis and treatment. Neurol Neurochir Pol. 2020;54(2):106-115. doi: 10.5603/PJNNS.a2020.0031. Epub 2020 Apr 14.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Serotonin and Noradrenaline Reuptake Inhibitors
- Venlafaxine Hydrochloride
Other Study ID Numbers
- 2021ZQ084
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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