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Vestibular MigraineNCT04664088

Acupuncture for Prophylaxis of Vestibular Migraine

A study testing Acupuncture and Venlafaxine in people with Vestibular Migraine, run by Affiliated Hospital of Jiaxing University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

With its high incidence rate and low diagnosis rate, vestibular migraine (VM) can seriously affect patients' quality of life. Current treatment of VM mainly contain rescue treatment and prophylaxis, both of which are often pharmacological-based therapies and bring a series of unavoidable side effects, which leads to… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Vestibular Migraine
What is being tested?
Acupuncture and Venlafaxine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteChina
Study dates
1 Jan 2021to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Tianye Hu, MM contact

86-18357046386

tianye_hty@gmail.com

China1 site

  • The First Affiliated Hospital of Jiaxing University

    Jiaxing, Zhejiang, 314000

    Tianye Hu, MM, 86-18357048386, tianye_hty@gmail.com

    Jin Hu, MM, 86-13819347974, leihendieyu@sina.com

Other trials in China

About this study

Official title: The Efficacy and Safety of Acupuncture for Prophylaxis of Vestibular Migraine

With its high incidence rate and low diagnosis rate, vestibular migraine (VM) can seriously affect patients' quality of life. Current treatment of VM mainly contain rescue treatment and prophylaxis, both of which are often pharmacological-based therapies and bring a series of unavoidable side effects, which leads to poor compliance of patients. Moreover, frequent VM attacks can seriously affect patients' daily life and work. Therefore, prophylaxis treatment is of great significance for VM patients. As a non-pharmarceutical therapy, acupuncture is widely used for a wide range of migrainous and emotional disorders. Thus, it might be an alternative treatment for VM, but current evidence remains inconclusive. The aim of this randomized controlled trial is to investigate the prophylactic efficacy and safety of acupuncture therapy in patients with VM.

Read the detailed description

This randomized controlled trial will enroll patients with vestibular migraine from the First Affiliated Hospital of Jiaxing University. All participants will be randomly assigned to two groups. Participants will receive acupuncture in the treatment group, while participants in the control group will be treated by venlafaxine. All treatments will be given for 8 weeks. The primary outcome measures are change in vertigo/migraine days and vertigo/migraine attacks, vertigo severity, and migraine intensity per 4 weeks from baseline. The secondary outcome measures are change in dosage of rescue medication, anxiety level，depression level，and quality of life per 4 weeks from baseline.

Being tested
Acupuncture, Venlafaxine
Keywords
vestibular migraine, randomized controlled trial, acupuncture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcupunctureProcedure or surgery

    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.

  • VenlafaxineDrug

    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.

Study groups in NCT04664088
Study groupRoleWhat they receive
Acupuncture groupExperimentalPatients in this group will receive acupuncture once every other day (3 days per week) over an 8-week period (a total of 24 sessions).
Receives: Procedure: Acupuncture
Medication groupActive comparatorParticipants in this group will receive oral administration of venlafaxine 50 mg once a day for 8 weeks.
Receives: Drug: Venlafaxine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the number of vertigo/migraine days and vertigo/migraine attacks

    The number of vertigo/migraine days and vertigo/migraine attacks will be assessed by a patient diary.

    Measured: 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up

  2. Change in vertigo severity

    Vertigo severity will be measured by dizziness handicap inventory (DHI)

    Measured: 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up

  3. Change in migraine intensity

    Migraine intensity will be measured by visual analogue scale (VAS)

    Measured: 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up

Secondary outcomes (4)

  1. Change in doses of rescue medication

    Doses of rescue medication (triptans) will be documented by patients in the patient diary.

    Measured: 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up

  2. Change in anxiety level

    Anxiety level will be measured by Generalized Anxiety Disorder-7 (GAD-7) scale.

    Measured: 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up

  3. Change in depression level

    Depression level will be measured by Patient Health Questionnaire (PHQ-9) scale

    Measured: 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up

  4. Change in quality of life

    Quality of life will be measure by 36-item short form health survey (SF-36).

    Measured: 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2020
  2. Study start1 Jan 2021 (estimated)
  3. Primary completion30 Jun 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04664088
Sponsor's protocol ID
2021ZQ084
Status last verified
Dec 2020
First submitted
6 Dec 2020
Last updated
11 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 31094996

  • 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.

    PubMed 30759189

  • 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.

    PubMed 26017509

  • 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.

    PubMed 26614042

  • 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.

    PubMed 32285435

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture and Venlafaxine in people with Vestibular Migraine, run by Affiliated Hospital of Jiaxing University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tianye Hu, MM (86-18357046386, tianye_hty@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04664088, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.

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