MigraineNCT07451158
Multicenter, Double-blind, and Randomized Controlled Trial of Ultra-Distal TENS Device for Migraine Treatment
A study testing Trail of Ultral-distal Transcutaneous Electrical Nerve Stimulation and Fake Stimulus in people with Migraine, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Multicenter, double-blind, and randomized controlled trial of Ultra-Distal Transcutaneous Electrical Nerve Stimulation (TENS) Device for Migraine treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Migraine
- What is being tested?
- Trail of Ultral-distal Transcutaneous Electrical Nerve Stimulation and Fake Stimulus
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2025to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged between 18 and 75;
- According to the diagnostic criteria of the International Classification of Headache Disorders (ICHD-III), the diagnosis is episodic migraine with or without aura or probable migraine with or without aura;
- The duration of the illness is at least 12 months;
- The age of onset of the first migraine is less than 50 years old;
- During the screening period of 4 weeks, there were 2-8 episodes of headache, with moderate or severe pain intensity;
- Before screening, the subjects should provide their previous medical records as much as possible;
- Participants can distinguish migraines from other conditions, including tension-type headaches and cluster headaches
- Understand and adhere to the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing;
Who cannot join
- Pregnant and lactating women;
- Suffering from arrhythmia or other heart diseases (such as ischemic heart disease, coronary artery spasm, myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, angina pectoris);
- Have undergone surgery within the past 6 months;
- Recent stroke or transient ischemic attack;
- Equipped with a pacemaker;
- History of previous seizures;
Show all 13Show fewer
- Metal implants in the head;
- Patients with clinical evidence of brain damage;
- Chronic pain associated with other diseases;
- Use antipsychotic drugs;
- Those who are intolerant to neuroregulators;
- Employees of the research center or their immediate family members.
- There is a condition or anomaly that the investigator believes may affect patient safety or data quality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Double-blind, and Randomized Controlled Trial of Ultra-Distal Transcutaneous Electrical Nerve Stimulation (TENS) Device for Migraine Treatment
Multicenter, double-blind, and randomized controlled trial of Ultra-Distal Transcutaneous Electrical Nerve Stimulation (TENS) Device for Migraine treatment.
- Conditions
- Migraine
- Being tested
- Trail of Ultral-distal Transcutaneous Electrical Nerve Stimulation, Fake Stimulus
- Keywords
- migraine, Transcetaneous Electrical Stimulation
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trail of Ultral-distal Transcutaneous Electrical Nerve StimulationDevice
When subjects report experiencing or impending headache episodes, complete the VAS assessment and immediately administer transcutaneous electrical stimulation (TENS) therapy in the treatment area. Prior to activating the TENS wristband, first initiate EEG recording and maintain 5 minutes of rest. Subsequently, activate the TENS wristband for neuromodulation therapy while continuing rest and recording. After headache subsides, repeat the VAS assessment and maintain rest for 5 minutes before concluding. A safety follow-up (telephone consultation or online questionnaire) should be completed one week after the treatment session.
Fake StimulusDevice
When subjects experience or anticipate headache onset, complete the VAS assessment and immediately administer transcutaneous electrical stimulation (TENS) in a non-treatment area. Before activating the TENS wristband, first initiate EEG recording and maintain 5 minutes of rest. Then activate the TENS wristband for neuromodulation therapy while continuing rest and recording. After headache subsides, repeat the VAS assessment and maintain rest for 5 minutes before concluding. Complete a safety follow-up one week after the same-day treatment (via telephone consultation or online questionnaire).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Transcetaneous Electrical Stimulation Receives: Device: Trail of Ultral-distal Transcutaneous Electrical Nerve Stimulation |
| Group B | Placebo comparator | Fake Stimulus Group Receives: Device: Fake Stimulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce the intensity of migraine
After treatment, participants rated their headache intensity as 0 (no pain =0 points, mild =1 point, moderate =2 points, severe =3 points).
Measured: Baseline and 2 hours post-treatment
the pre-selected accompanying symptoms
Participants no longer experienced the pre-selected accompanying symptoms (e.g., nausea, vomiting, photophobia, phonophobia) after 2 hours of treatment.
Measured: Baseline and 2 hours post-treatment
Secondary outcomes (7)
pain relief
Pain relief measured by Visual Analogue Scale (VAS)：Number of participants transitioning from moderate to mild pain at 2 hours post-treatment.
Measured: Baseline and 2 hours post-treatment
returned to normal function
Number of participants who resumed normal daily activities (e.g., ability to ambulate freely or return to work/school) by 2 hours post-treatment.
Measured: Baseline and 2 hours post-treatment
Use of acute treatment drugs
Use of acute treatment drugs within 24 hours of treatment
Measured: Baseline and 24 hours post-treatment
recurrence of migraine
No recurrence of migraine attack occurred within 2-24 hours after treatment
Measured: Baseline and 2-24 hours post-treatment
recurrence of migraine2
No recurrence of migraine attack occurred within 2-48 hours after treatment
Measured: Baseline and 2-48 hours post-treatment
pain-free status
Participants achieved pain-free status (VAS score 0) at 15,30,45,60, and 90 minutes post-treatment, having progressed from moderate to severe pain.
Measured: Baseline and 15,30,45,60, and 90 minutes post-treatment
symptoms free
Participants' accompanying symptoms (e.g., nausea, vomiting, photophobia, phonophobia) did not reappear at 15,30,45,60, and 90 minutes after treatment
Measured: Baseline and 15,30,45,60, and 90 minutes post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start15 Nov 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Huzhou Central Hospital, Ningbo Medical Center Lihuili Hospital, Hangzhou Hospital of Traditional Chinese Medicine, The first people Hospital of Linhai
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451158
- Sponsor's protocol ID
- 2025-1038
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is necessary to explore how personal information is protected.
Publications
Moisset X, Pereira B, Ciampi de Andrade D, Fontaine D, Lanteri-Minet M, Mawet J. Neuromodulation techniques for acute and preventive migraine treatment: a systematic review and meta-analysis of randomized controlled trials. J Headache Pain. 2020 Dec 10;21(1):142. doi: 10.1186/s10194-020-01204-4.
PubMed 33302882Weatherall MW, Nandi D. Percutaneous electrical nerve stimulation (PENS) therapy for refractory primary headache disorders: a pilot study. Br J Neurosurg. 2019 Dec;33(6):608-612. doi: 10.1080/02688697.2019.1671951. Epub 2019 Oct 3.
PubMed 31578882Ashina M, Katsarava Z, Do TP, Buse DC, Pozo-Rosich P, Ozge A, Krymchantowski AV, Lebedeva ER, Ravishankar K, Yu S, Sacco S, Ashina S, Younis S, Steiner TJ, Lipton RB. Migraine: epidemiology and systems of care. Lancet. 2021 Apr 17;397(10283):1485-1495. doi: 10.1016/S0140-6736(20)32160-7. Epub 2021 Mar 25.
PubMed 33773613Tufail Y, Yoshihiro A, Pati S, Li MM, Tyler WJ. Ultrasonic neuromodulation by brain stimulation with transcranial ultrasound. Nat Protoc. 2011 Sep 1;6(9):1453-70. doi: 10.1038/nprot.2011.371.
PubMed 21886108Tang Z, Ma Q, Li Q, Hu J, Wang C, Jiao W, Song X, Wu Y, Du L, Jin Y. Advances in applications of head mounted devices (HMDs): Physical techniques for drug delivery and neuromodulation. J Control Release. 2023 Feb;354:810-820. doi: 10.1016/j.jconrel.2023.01.061. Epub 2023 Jan 30.
PubMed 36709924
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Double-blind, and Randomized Controlled Trial of Ultra-Distal Transcutaneous Electrical Nerve Stimulation (TENS) Device for Migraine Treatment
- ClinicalTrials.gov ID
- NCT07451158
- Acronym / sponsor ID
- 2025-1038
- Conditions
- Migraine
- Keywords
- migraine, Transcetaneous Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Huzhou Central Hospital, Ningbo Medical Center Lihuili Hospital, Hangzhou Hospital of Traditional Chinese Medicine, The first people Hospital of Linhai
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter, double-blind, and randomized controlled trial of Ultra-Distal Transcutaneous Electrical Nerve Stimulation (TENS) Device for Migraine treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Trail of Ultral-distal Transcutaneous Electrical Nerve StimulationTranscetaneous Electrical Stimulation |
| Group B | Placebo comparator | Device: Fake StimulusFake Stimulus Group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, aged between 18 and 75;
- According to the diagnostic criteria of the International Classification of Headache Disorders (ICHD-III), the diagnosis is episodic migraine with or without aura or probable migraine with or without aura;
- The duration of the illness is at least 12 months;
- The age of onset of the first migraine is less than 50 years old;
- During the screening period of 4 weeks, there were 2-8 episodes of headache, with moderate or severe pain intensity;
Key exclusion criteria (13 listed)
- Pregnant and lactating women;
- Suffering from arrhythmia or other heart diseases (such as ischemic heart disease, coronary artery spasm, myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, angina pectoris);
- Have undergone surgery within the past 6 months;
- Recent stroke or transient ischemic attack;
- Equipped with a pacemaker;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trail of Ultral-distal Transcutaneous Electrical Nerve StimulationWhen subjects report experiencing or impending headache episodes, complete the VAS assessment and immediately administer transcutaneous electrical stimulation (TENS) therapy in the treatment area. Prior to activating the TENS wristband, first initiate EEG recording and maintain 5 minutes of rest. Subsequently, activate the TENS wristband for neuromodulation therapy while continuing rest and recording. After headache subsides, repeat the VAS assessment and maintain rest for 5 minutes before concluding. A safety follow-up (telephone consultation or online questionnaire) should be completed one week after the treatment session. | Device | Group A |
| Fake StimulusWhen subjects experience or anticipate headache onset, complete the VAS assessment and immediately administer transcutaneous electrical stimulation (TENS) in a non-treatment area. Before activating the TENS wristband, first initiate EEG recording and maintain 5 minutes of rest. Then activate the TENS wristband for neuromodulation therapy while continuing rest and recording. After headache subsides, repeat the VAS assessment and maintain rest for 5 minutes before concluding. Complete a safety follow-up one week after the same-day treatment (via telephone consultation or online questionnaire). | Device | Group B |
Primary outcome
Reduce the intensity of migraine
Time frame: Baseline and 2 hours post-treatment
After treatment, participants rated their headache intensity as 0 (no pain =0 points, mild =1 point, moderate =2 points, severe =3 points).
the pre-selected accompanying symptoms
Time frame: Baseline and 2 hours post-treatment
Participants no longer experienced the pre-selected accompanying symptoms (e.g., nausea, vomiting, photophobia, phonophobia) after 2 hours of treatment.
7 secondary outcomes
pain relief
Time frame: Baseline and 2 hours post-treatment
returned to normal function
Time frame: Baseline and 2 hours post-treatment
Use of acute treatment drugs
Time frame: Baseline and 24 hours post-treatment
recurrence of migraine
Time frame: Baseline and 2-24 hours post-treatment
recurrence of migraine2
Time frame: Baseline and 2-48 hours post-treatment
pain-free status
Time frame: Baseline and 15,30,45,60, and 90 minutes post-treatment
symptoms free
Time frame: Baseline and 15,30,45,60, and 90 minutes post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Results publication: PubMed 33302882Moisset X, Pereira B, Ciampi de Andrade D, Fontaine D, Lanteri-Minet M, Mawet J. Neuromodulation techniques for acute and preventive migraine treatment: a systematic review and meta-analysis of randomized controlled trials. J Headache Pain. 2020 Dec 10;21(1):142. doi: 10.1186/s10194-020-01204-4.
- Results publication: PubMed 31578882Weatherall MW, Nandi D. Percutaneous electrical nerve stimulation (PENS) therapy for refractory primary headache disorders: a pilot study. Br J Neurosurg. 2019 Dec;33(6):608-612. doi: 10.1080/02688697.2019.1671951. Epub 2019 Oct 3.
- Results publication: PubMed 33773613Ashina M, Katsarava Z, Do TP, Buse DC, Pozo-Rosich P, Ozge A, Krymchantowski AV, Lebedeva ER, Ravishankar K, Yu S, Sacco S, Ashina S, Younis S, Steiner TJ, Lipton RB. Migraine: epidemiology and systems of care. Lancet. 2021 Apr 17;397(10283):1485-1495. doi: 10.1016/S0140-6736(20)32160-7. Epub 2021 Mar 25.
- Results publication: PubMed 21886108Tufail Y, Yoshihiro A, Pati S, Li MM, Tyler WJ. Ultrasonic neuromodulation by brain stimulation with transcranial ultrasound. Nat Protoc. 2011 Sep 1;6(9):1453-70. doi: 10.1038/nprot.2011.371.
- Results publication: PubMed 36709924Tang Z, Ma Q, Li Q, Hu J, Wang C, Jiao W, Song X, Wu Y, Du L, Jin Y. Advances in applications of head mounted devices (HMDs): Physical techniques for drug delivery and neuromodulation. J Control Release. 2023 Feb;354:810-820. doi: 10.1016/j.jconrel.2023.01.061. Epub 2023 Jan 30.
- Individual participant dataSharing planned: Undecided. It is necessary to explore how personal information is protected.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trail of Ultral-distal Transcutaneous Electrical Nerve Stimulation and Fake Stimulus in people with Migraine, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 8 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Reduce the intensity of migraine (time frame: Baseline and 2 hours post-treatment). The study lists 2 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 NCT07451158, 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 5 Mar 2026.