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Transcutaneous Electrical Acupoint StimulationNCT04621578

Transcutaneous Electrical Acupoint Stimulation on Postoperative Dizziness in Hemifacial Spasm Patients

A study testing HANS 100B stimulator (4 conductors, 8 electrodes; Jisheng Co., Nanjing, China) in people with Transcutaneous Electrical Acupoint Stimulation and Hemifacial Spasm, run by Peking University People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To observe the prevention and treatment effect of transcutaneous electrical acupoint stimulation (TEAS) on postoperative dizziness in patients with hemifacial spasm undergoing microvascular decompression surgery, and its possible mechanisms. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
HANS 100B stimulator (4 conductors, 8 electrodes; Jisheng Co., Nanjing, China)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
86 participants
Where
1 siteChina
Study dates
6 Dec 2020to 30 Jul 2021
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • American Society of Anesthesiologists (ASA) physical status: I-III
  • Body mass index (BMI): 18-30
  • Diagnosed of hemifacial spasm
  • Undergoing microvascular decompression surgery

Who cannot join

  • Pregnant or lactating women
  • Poorly controlled hypertension or poorly controlled diabetes, severe cardiovascular and cerebrovascular diseases and mental illness
  • Cardiac pacemakers
  • Scars on bilateral Neiguan acupoints or on the mastoid area
  • Upper limb nerve injury
  • Raynaud's syndrome
Show all 9Show fewer
  • Motion sickness or PONV history
  • Eye diseases (glaucoma, cataracts, eye trauma, etc.) or previous eye surgery
  • Participate in other clinical trials

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

Other trials in China

About this study

Official title: The Effect of Prevention and Treatment of Transcutaneous Electrical Acupoint Stimulation on Postoperative Dizziness in Patients With Hemifacial Spasm Undergoing Microvascular Decompression Surgery: A Randomized Controlled Trial

To observe the prevention and treatment effect of transcutaneous electrical acupoint stimulation (TEAS) on postoperative dizziness in patients with hemifacial spasm undergoing microvascular decompression surgery, and its possible mechanisms.

Read the detailed description

Hemifacial spasm (HFS) is mainly caused by vascular compression on the roots of the VII cranial nerves from the brain stem. Microvascular decompression (MVD) is the exact surgical method for the treatment of HFS, but the incidence of dizziness and postoperative nausea and vomiting (PONV) after MVD is extremely high. Despite the use of dual antiemetic therapy during the operation, the incidence of PONV within 24 hours after MVD is still as high as 66.7%. Medication alone has limited effects on dizziness and PONV treatment after MVD. Meta-analysis shows that transcutaneous electrical acupoint stimulation (TEAS) is associated with the reduction of post-emetic remedies and the incidence of dizziness after general anesthesia, and it can be integrated into the multi-modal therapy of PONV. Therefore, the purpose of our study is to observe the prevention and treatment effect of TEAS on postoperative dizziness in patients with hemifacial spasm undergoing microvascular decompression surgery, and explore its possible mechanisms.

Being tested
HANS 100B stimulator (4 conductors, 8 electrodes; Jisheng Co., Nanjing, China)
Medical subject headings
Hemifacial Spasm, Dizziness

What participants receive

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

  • HANS 100B stimulator (4 conductors, 8 electrodes; Jisheng Co., Nanjing, China)Device

    Stimulation sites: Mastoid area on the contralateral side of the operation, Fengchi acupoint on the contralateral side of the operation, and Neiguan acupoints on both sides.

    Timing of stimulation: In postanesthesia care unit (PACU) after extubation, 6 hours, 24 hours, 48 hours, and 72 hours after returning to the ward. 30-minutes treatment for each time-point.

Study groups in NCT04621578
Study groupRoleWhat they receive
Transcutaneous electrical acupoint stimulation armExperimentalPatients will be given TEAS treatment at the maximum tolerable intensity at a frequency of 2 Hertz (Hz) after surgery in postanesthesia care unit (PACU), and after returning to the ward.
Receives: Device: HANS 100B stimulator (4 conductors, 8 electrodes; Jisheng Co., Nanjing, China)
Sham stimulation armSham comparatorPatients will use the same device, same stimulation site, and be treated at the same time points, but the lead of the device was damaged. Therefore, although the patients can see the stimulator running, there is actually no current passing through.
Receives: Device: HANS 100B stimulator (4 conductors, 8 electrodes; Jisheng Co., Nanjing, China)

What is being measured

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

  1. The incidence of dizziness at 2 hours after returning to the ward on the day of surgery

    The patients and their families will be asked to record a diary about their symptoms of dizziness, nausea, vomiting and headache after surgery, and they will be followed up after surgery.

    Measured: 2 hours after returning to the ward on the day of surgery

Secondary outcomes (10)

  1. Numerical rating scale (NRS) score of postoperative dizziness

    A 0-10 point numerical rating scale (NRS) will be used for evaluation of the severity of postoperative dizziness. 0 means no dizziness, and 10 means very severe dizziness. The degree of dizziness worsens as the number increases.

    Measured: In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward.

  2. The incidence and severity of postoperative nausea

    Nausea severity will be evaluated by a 0-10 point numerical rating scale (NRS). 0 means no nausea, and 10 means very severe nausea. The degree of nausea worsens as the number increases.

    Measured: In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward.

  3. The number of vomiting after surgery

    Vomiting times after surgery.

    Measured: In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward.

  4. The use of remedial drugs after surgery

    Drug used for anti-emetic or anti-dizziness after surgery.

    Measured: From the day of surgery to 72 hours after surgery.

  5. The incidence and severity of postoperative headache

    Headache severity will be evaluated by a 0-10 point numerical rating scale (NRS). 0 means no headache, and 10 means very severe headache. The degree of headache worsens as the number increases.

    Measured: In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward.

  6. Changes in intraocular pressure before and after surgery

    Intraocular pressure will be measured by a non-contact tonometer before and after surgery by the same operator.

    Measured: Before anesthesia induction, and before leaving PACU on the day of surgery.

  7. Gastrin and 5-Hydroxytryptamine (5-HT) levels in serum and cerebrospinal fluid

    Peripheral blood will be collected before and after surgery, and cerebrospinal fluid (CSF) will be collected during the surgery.

    Measured: The peripheral blood samples will be collected on the day of surgery, and on postoperative day 1. The CSF samples will be collected on the day of surgery.

  8. Postoperative complications monitoring

    The Clavien-Dindo grading system will be used.

    Measured: From the day of surgery to the day of discharge.

  9. Postoperative duration of stay in hospital

    The duration when patients stay in hospital after surgery.

    Measured: From the day of surgery to the day of discharge.

  10. Dizziness symptoms 4 weeks after discharge

    Patients will be followed up by telephone 4 weeks after discharge, and the Dizziness Handicap Inventory (DHI) will be used for measurement.

    Measured: 4 weeks after discharge.

Timeline

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

  1. First posted9 Nov 2020
  2. Study start6 Dec 2020
  3. Primary completion25 Jun 2021
  4. Study completion30 Jul 2021

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04621578
Sponsor's protocol ID
2020PHB232-01
Status last verified
May 2022
First submitted
3 Nov 2020
Last updated
1 Jun 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Miller LE, Miller VM. Safety and effectiveness of microvascular decompression for treatment of hemifacial spasm: a systematic review. Br J Neurosurg. 2012 Aug;26(4):438-44. doi: 10.3109/02688697.2011.641613. Epub 2011 Dec 15.

    PubMed 22168965

  • Thongrong C, Chullabodhi P, Kasemsiri P, Kitkhuandee A, Plailaharn N, Sabangban L, Jimarsa T. Effects of Intraoperative Dexamethasone and Ondansetron on Postoperative Nausea and Vomiting in Microvascular Decompression Surgery: A Randomized Controlled Study. Anesthesiol Res Pract. 2018 Nov 11;2018:6297362. doi: 10.1155/2018/6297362. eCollection 2018.

    PubMed 30534153

  • Chen J, Tu Q, Miao S, Zhou Z, Hu S. Transcutaneous electrical acupoint stimulation for preventing postoperative nausea and vomiting after general anesthesia: A meta-analysis of randomized controlled trials. Int J Surg. 2020 Jan;73:57-64. doi: 10.1016/j.ijsu.2019.10.036. Epub 2019 Nov 6.

    PubMed 31704425

Questions about this trial

What is this clinical trial studying?

A study testing HANS 100B stimulator (4 conductors, 8 electrodes; Jisheng Co., Nanjing, China) in people with Transcutaneous Electrical Acupoint Stimulation and Hemifacial Spasm, run by Peking University People's Hospital 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 1 Jun 2022. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of dizziness at 2 hours after returning to the ward on the day of surgery (time frame: 2 hours after returning to the ward on the day of surgery). 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 NCT04621578, which also lists 3 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 1 Jun 2022.

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