MigraineNCT07055776
Compare the Effectiveness of nVNS and TENS on Pain and Quality of Life in Patients of Migraine
A study testing non-invasive vagus nerve stimulation (nVNS) and non-invasive transcutaneous electrical nerve stimulation (TENS) in people with Migraine, run by Superior University at 1 site in Pakistan.
Trial summary
Migraine is a genetically influenced complex neurological disorder characterized by episodes of moderate-to-severe headaches, typically unilateral and frequently accompanied by nausea and heightened sensitivity to light and sound. The common type of migraine headaches is migraine without aura. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Migraine
- What is being tested?
- non-invasive vagus nerve stimulation (nVNS) and non-invasive transcutaneous electrical nerve stimulation (TENS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Mar 2025to 28 Feb 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
- People will be eligible for participation of 18-75 years of age.
- Participants are included with previous diagnosis of migraine with aura according to ICHD-3 beta criteria.
- Patients who had 15 headache days per month over the last 6 months will be included in this study.
Who cannot join
- Participants with a history of secondary headaches,
- aneurysms, brain tumors, significant head trauma
- substance abuse, cardiovascular or cerebrovascular disease
- uncontrolled hypertension, psychiatric disorders,
- pregnancy, steroid use, botulinum toxin injections in the past 6 months, or certain other medical conditions were excluded.
- individuals with excessive use of pain medications, recent preventive treatments, or previous surgeries and procedures related to migraines will not be eligible.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
Lahore, Punjab Province
About this study
Official title: Compare the Effectiveness of Non-invasive Vagus Nerve Stimulation (nVNS) and Non-invasive Transcutaneous Electrical Nerve Stimulation (TENS) on Pain and Quality of Life (QOL) in Patients of Migraine: a Randomized Control Trial
Migraine is a genetically influenced complex neurological disorder characterized by episodes of moderate-to-severe headaches, typically unilateral and frequently accompanied by nausea and heightened sensitivity to light and sound. The common type of migraine headaches is migraine without aura. Migraine has an approximate prevalence of 14.7%, making it the third most common disease in the world. This study aims to compare the effectiveness of non-invasive vagus nerve stimulation (nVNS) and non-invasive transcutaneous electrical nerve stimulation (TENS) in managing pain and improving quality of life (QOL) in patients with migraine.
- Conditions
- Migraine
- Being tested
- non-invasive vagus nerve stimulation (nVNS), non-invasive transcutaneous electrical nerve stimulation (TENS)
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive vagus nerve stimulation (nVNS)Combination product
Group 1 will receive non-invasive vagus nerve stimulation (nVNS) targeting the auricular branch of the vagus nerve (ABVN) using a TENS device with specialized ear clip electrodes. The electrodes will be placed on the cymba conchae or tragus region of the ear, where the ABVN is accessible. The stimulation parameters will be set to a frequency of 1 Hz (significantly reduced migraine headache), pulse width of 200-300 µs, and intensity adjusted to a strong but comfortable level without causing pain, applied for 15-30 minutes per session, 5 days a week for 12 weeks, based on protocols supported by evidence from studies such as Badran et al. (2018) and Yakunina et al. (2017), which demonstrated positive neuromodulatory effects through auricular stimulation. Baseline conventional physiotherapy for both groups will include: thermotherapy (e.g., moist hot packs for 15 minutes), range of motion (ROM) exercises, stretching of involved muscles, and strengthening exercises.
non-invasive transcutaneous electrical nerve stimulation (TENS)Combination product
Group 2 will receive non-invasive transcutaneous electrical nerve stimulation (TENS) applied to the other areas to target other nerves stimulation (e.g., neck, upper trapezius, or occipital area). Surface electrodes will be placed paravertebrally, using a conventional TENS protocol: frequency of 20-25 Hz, pulse width of 200-300 µs, and intensity set to produce a strong but comfortable tingling sensation without muscle contraction. Each session will last 20-30 minutes, administered 5 days a week for 12 weeks. Baseline conventional physiotherapy for both groups will include: thermotherapy (e.g., moist hot packs for 15 minutes), range of motion (ROM) exercises, stretching of involved muscles, and strengthening exercises.
| Study group | Role | What they receive |
|---|---|---|
| non-invasive vagus nerve stimulation (nVNS) | Experimental | Not described Receives: Combination Product: non-invasive vagus nerve stimulation (nVNS) |
| non-invasive transcutaneous electrical nerve stimulation (TENS) | Experimental | Not described Receives: Combination Product: non-invasive transcutaneous electrical nerve stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
The Visual Analogue Scale (VAS) is a simple tool used to measure the intensity of pain or symptoms. It typically uses a 10 cm (100 mm) horizontal line, where:
0 = No pain 10 = Worst imaginable pain
Measured: 12 Months
HIT-6 (Headache impact test)
The HIT-6 (Headache Impact Test) is a tool used to assess the impact of headaches, particularly migraines, on a person's daily life. It evaluates how headaches/pain affect daily functioning, work, social activities, and emotional well-being. The HIT-6 consists of 6 items. Each item is rated on a 5-point Likert scale (1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Very often, and 5 = Always). The individual responses are summed to obtain a total score that ranges from 36 to 78, with higher scores indicating greater headache impact and lower scores indicating less impact (below 50 suggests low impact, between 50 and 55 suggests moderate impact, and above 55 suggests severe impact).
Measured: 12 Months
MIDAS (Migraine Disability Assessment)
The MIDAS (Migraine Disability Assessment) scale is a tool used to assess how migraines impact a person's daily life over the past three months. It includes five questions that ask about the number of days missed or affected in work, school, household tasks, and social activities due to migraines. The total number of days gives a MIDAS score, which is then categorized into four grades: Grade I (0-5) for little or no disability, Grade II (6-10) for mild, Grade III (11-20) for moderate, and Grade IV (21+) for severe disability. This helps clinicians evaluate the level of functional impairment caused by migraines
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start17 Mar 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055776
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/829
- Status last verified
- Jun 2025
- First submitted
- 28 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Effectiveness of Non-invasive Vagus Nerve Stimulation (nVNS) and Non-invasive Transcutaneous Electrical Nerve Stimulation (TENS) on Pain and Quality of Life (QOL) in Patients of Migraine: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07055776
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/829
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 9 Jul 2025 (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.
Migraine is a genetically influenced complex neurological disorder characterized by episodes of moderate-to-severe headaches, typically unilateral and frequently accompanied by nausea and heightened sensitivity to light and sound. The common type of migraine headaches is migraine without aura. Migraine has an approximate prevalence of 14.7%, making it the third most common disease in the world. This study aims to compare the effectiveness of non-invasive vagus nerve stimulation (nVNS) and non-invasive transcutaneous electrical nerve stimulation (TENS) in managing pain and improving quality of life (QOL) in patients with migraine.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-invasive vagus nerve stimulation (nVNS) | Experimental | Combination Product: non-invasive vagus nerve stimulation (nVNS) |
| non-invasive transcutaneous electrical nerve stimulation (TENS) | Experimental | Combination Product: non-invasive transcutaneous electrical nerve stimulation (TENS) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- People will be eligible for participation of 18-75 years of age.
- Participants are included with previous diagnosis of migraine with aura according to ICHD-3 beta criteria.
- Patients who had 15 headache days per month over the last 6 months will be included in this study.
Key exclusion criteria (6 listed)
- Participants with a history of secondary headaches,
- aneurysms, brain tumors, significant head trauma
- substance abuse, cardiovascular or cerebrovascular disease
- uncontrolled hypertension, psychiatric disorders,
- pregnancy, steroid use, botulinum toxin injections in the past 6 months, or certain other medical conditions were excluded.
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 |
|---|---|---|
| non-invasive vagus nerve stimulation (nVNS)Group 1 will receive non-invasive vagus nerve stimulation (nVNS) targeting the auricular branch of the vagus nerve (ABVN) using a TENS device with specialized ear clip electrodes. The electrodes will be placed on the cymba conchae or tragus region of the ear, where the ABVN is accessible. The stimulation parameters will be set to a frequency of 1 Hz (significantly reduced migraine headache), pulse width of 200-300 µs, and intensity adjusted to a strong but comfortable level without causing pain, applied for 15-30 minutes per session, 5 days a week for 12 weeks, based on protocols supported by evidence from studies such as Badran et al. (2018) and Yakunina et al. (2017), which demonstrated positive neuromodulatory effects through auricular stimulation. Baseline conventional physiotherapy for both groups will include: thermotherapy (e.g., moist hot packs for 15 minutes), range of motion (ROM) exercises, stretching of involved muscles, and strengthening exercises. | Combination product | non-invasive vagus nerve stimulation (nVNS) |
| non-invasive transcutaneous electrical nerve stimulation (TENS)Group 2 will receive non-invasive transcutaneous electrical nerve stimulation (TENS) applied to the other areas to target other nerves stimulation (e.g., neck, upper trapezius, or occipital area). Surface electrodes will be placed paravertebrally, using a conventional TENS protocol: frequency of 20-25 Hz, pulse width of 200-300 µs, and intensity set to produce a strong but comfortable tingling sensation without muscle contraction. Each session will last 20-30 minutes, administered 5 days a week for 12 weeks. Baseline conventional physiotherapy for both groups will include: thermotherapy (e.g., moist hot packs for 15 minutes), range of motion (ROM) exercises, stretching of involved muscles, and strengthening exercises. | Combination product | non-invasive transcutaneous electrical nerve stimulation (TENS) |
Primary outcome
Visual analogue scale (VAS)
Time frame: 12 Months
The Visual Analogue Scale (VAS) is a simple tool used to measure the intensity of pain or symptoms. It typically uses a 10 cm (100 mm) horizontal line, where: 0 = No pain 10 = Worst imaginable pain
HIT-6 (Headache impact test)
Time frame: 12 Months
The HIT-6 (Headache Impact Test) is a tool used to assess the impact of headaches, particularly migraines, on a person's daily life. It evaluates how headaches/pain affect daily functioning, work, social activities, and emotional well-being. The HIT-6 consists of 6 items. Each item is rated on a 5-point Likert scale (1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Very often, and 5 = Always). The individual responses are summed to obtain a total score that ranges from 36 to 78, with higher scores indicating greater headache impact and lower scores indicating less impact (below 50 suggests low impact, between 50 and 55 suggests moderate impact, and above 55 suggests severe impact).
MIDAS (Migraine Disability Assessment)
Time frame: 12 Months
The MIDAS (Migraine Disability Assessment) scale is a tool used to assess how migraines impact a person's daily life over the past three months. It includes five questions that ask about the number of days missed or affected in work, school, household tasks, and social activities due to migraines. The total number of days gives a MIDAS score, which is then categorized into four grades: Grade I (0-5) for little or no disability, Grade II (6-10) for mild, Grade III (11-20) for moderate, and Grade IV (21+) for severe disability. This helps clinicians evaluate the level of functional impairment caused by migraines
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 9 Jul 2025.
- Individual participant dataSharing planned: No
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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 non-invasive vagus nerve stimulation (nVNS) and non-invasive transcutaneous electrical nerve stimulation (TENS) in people with Migraine, run by Superior University at 1 site in Pakistan.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2025. 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 Pakistan. 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?
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?
Visual analogue scale (VAS) (time frame: 12 Months). 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?
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 9 Jul 2025.