MigraineNCT06191016
Vagal Nerve Stimulation and Pain Frequency, Intensity in Chronic Migraine
A study testing Vagal nerve stimulation in people with Migraine, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study is being conducted to address the need for effective and well-tolerated interventions in preventing chronic migraine attacks. Chronic migraines significantly impact the quality of life for individuals suffering from them, often leading to substantial discomfort and impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Vagal nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Dec 2023to 31 Oct 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic migraine (headache for 15 or more days/month for more than three months), Migraine with/without aura
Who cannot join
- Mental illness, Photophobic individual, Presence of shunt and/or implant at the cranial region
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Pakistan Railway General Hospital
Rawalpindi, Punjab Province
Rabia Nasir, DPT, 00923319303051, Rabianasir123@gmail.com
Mirza Obaid Baig, MSPT, 0092 333 2238706, obaid.baig@riphah.edu.pk
About this study
Official title: Effects of Vagal Nerve Stimulation on Pain Frequency and Intensity in Chronic Migraine
This study is being conducted to address the need for effective and well-tolerated interventions in preventing chronic migraine attacks. Chronic migraines significantly impact the quality of life for individuals suffering from them, often leading to substantial discomfort and impairment. By evaluating the feasibility, safety, and acceptance of noninvasive vagus nerve stimulation (nVNS), researchers aim to determine if this approach can offer a viable solution for alleviating the frequency and severity of chronic migraine episodes. If successful, this study could potentially introduce a promising new treatment option that enhances the well-being and daily functioning of those affected by chronic migraines.
Read the detailed description
Neuromodulation is a growing field in headache management. Technology ranges from invasive deep brain stimulation (DBS) of the posterior hypothalamus, to minimally invasive percutaneous electrode implantation for occipital nerve stimulation, and noninvasive transcranial magnetic stimulation and transcranial direct current stimulation. Neurostimulation can be particularly useful to those who failed triptans or other prophylactic treatments. The European Headache Federation positioned that a neurostimulation device should only be used in medically intractable headache patient who has been evaluated at a tertiary headache center. Vagus nerve stimulation (VNS), which has demonstrated its antinociceptive potential, may also provide a relief of pain associated with headache
- Conditions
- Migraine
- Being tested
- Vagal nerve stimulation, Sham vagal nerve stimulation
- Keywords
- chronic migraine, vagal nerve stimulation, pain intensity and frequency
- Medical subject headings
- Migraine Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagal nerve stimulationDevice
Experimental group will receive noninvasive vagal nerve stimulation (nVNS) in addition to prescribed medications
Sham vagal nerve stimulationDevice
control will receive sham stimulation to vagal nerve along with prescribed medications
| Study group | Role | What they receive |
|---|---|---|
| nVNS Group | Experimental | Experimental group will receive noninvasive vagal nerve stimulation (nVNS) in addition to prescribed medications Receives: Device: Vagal nerve stimulation; Device: Sham vagal nerve stimulation |
| Sham Group | Active comparator | control will receive sham stimulation to vagal nerve along with prescribed medications. Receives: Device: Vagal nerve stimulation; Device: Sham vagal nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structured Headache Diary Data for frequency of migraine
Diaries and calendars make possible to record prospectively the characteristics of every attack and this may reduce the recall bias and increase the accuracy of the description.
Measured: Week 4
Numeric Pain Scale (NPS) for intensity of migraine
NPS was implemented in clinical practice due to its rapidity both verbally and in writing. Due to its convenience, it is common for hospitals to measure pain using the 0 to 10 NPS scale
Measured: Week 4
Multidimensional Pain Inventory (MPI) for migraine impact
The MPI was administered pretreatment. It is a 61-item self-administered questionnaire composed of 12 empirically derived scales designed to measure a patients' experiences of pain, their spouses responses to their pain, and their general activity levels
Measured: Week 4
Secondary outcomes (1)
Migraine-Specific Quality of Life Survey (MSQ 2.1) for quality of life
The MSQOL is a measure to assess the effects of migraine over the longer term on patient well-being over a nonspecified time period, and the MQoLQ is designed to measure the short-term impact of migraine over a 24-hour period following the start of therapy for migraine.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start26 Dec 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirza Obaid Baig, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191016
- Sponsor's protocol ID
- REC01746 Rabia Nasir
- Status last verified
- Jan 2024
- First submitted
- 19 Dec 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vukovic Cvetkovic V, Jensen RH. Neurostimulation for the treatment of chronic migraine and cluster headache. Acta Neurol Scand. 2019 Jan;139(1):4-17. doi: 10.1111/ane.13034. Epub 2018 Oct 29.
PubMed 30291633Tassorelli C, Grazzi L, de Tommaso M, Pierangeli G, Martelletti P, Rainero I, Dorlas S, Geppetti P, Ambrosini A, Sarchielli P, Liebler E, Barbanti P; PRESTO Study Group. Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study. Neurology. 2018 Jul 24;91(4):e364-e373. doi: 10.1212/WNL.0000000000005857. Epub 2018 Jun 15.
PubMed 29907608Lendvai IS, Maier A, Scheele D, Hurlemann R, Kinfe TM. Spotlight on cervical vagus nerve stimulation for the treatment of primary headache disorders: a review. J Pain Res. 2018 Aug 27;11:1613-1625. doi: 10.2147/JPR.S129202. eCollection 2018.
PubMed 30214271Martelletti P, Barbanti P, Grazzi L, Pierangeli G, Rainero I, Geppetti P, Ambrosini A, Sarchielli P, Tassorelli C, Liebler E, de Tommaso M; PRESTO Study Group. Correction to: Consistent effects of non-invasive vagus nerve stimulation (nVNS) for the acute treatment of migraine: additional findings from the randomized, sham-controlled, double-blind PRESTO trial. J Headache Pain. 2018 Dec 18;19(1):120. doi: 10.1186/s10194-018-0949-9.
PubMed 30563446
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vagal Nerve Stimulation on Pain Frequency and Intensity in Chronic Migraine
- ClinicalTrials.gov ID
- NCT06191016
- Acronym / sponsor ID
- REC01746 Rabia Nasir
- Conditions
- Migraine
- Keywords
- chronic migraine, vagal nerve stimulation, pain intensity and frequency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 26 Dec 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 5 Jan 2024 (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.
This study is being conducted to address the need for effective and well-tolerated interventions in preventing chronic migraine attacks. Chronic migraines significantly impact the quality of life for individuals suffering from them, often leading to substantial discomfort and impairment. By evaluating the feasibility, safety, and acceptance of noninvasive vagus nerve stimulation (nVNS), researchers aim to determine if this approach can offer a viable solution for alleviating the frequency and severity of chronic migraine episodes. If successful, this study could potentially introduce a promising new treatment option that enhances the well-being and daily functioning of those affected by chronic migraines.
Detailed description
Neuromodulation is a growing field in headache management. Technology ranges from invasive deep brain stimulation (DBS) of the posterior hypothalamus, to minimally invasive percutaneous electrode implantation for occipital nerve stimulation, and noninvasive transcranial magnetic stimulation and transcranial direct current stimulation. Neurostimulation can be particularly useful to those who failed triptans or other prophylactic treatments. The European Headache Federation positioned that a neurostimulation device should only be used in medically intractable headache patient who has been evaluated at a tertiary headache center. Vagus nerve stimulation (VNS), which has demonstrated its antinociceptive potential, may also provide a relief of pain associated with headache
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nVNS Group | Experimental | Device: Vagal nerve stimulation, Device: Sham vagal nerve stimulationExperimental group will receive noninvasive vagal nerve stimulation (nVNS) in addition to prescribed medications |
| Sham Group | Active comparator | Device: Vagal nerve stimulation, Device: Sham vagal nerve stimulationcontrol will receive sham stimulation to vagal nerve along with prescribed medications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic migraine (headache for 15 or more days/month for more than three months), Migraine with/without aura
Key exclusion criteria (1 listed)
- Mental illness, Photophobic individual, Presence of shunt and/or implant at the cranial region
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 |
|---|---|---|
| Vagal nerve stimulationExperimental group will receive noninvasive vagal nerve stimulation (nVNS) in addition to prescribed medications | Device | Sham Group, nVNS Group |
| Sham vagal nerve stimulationcontrol will receive sham stimulation to vagal nerve along with prescribed medications | Device | Sham Group, nVNS Group |
Primary outcome
Structured Headache Diary Data for frequency of migraine
Time frame: Week 4
Diaries and calendars make possible to record prospectively the characteristics of every attack and this may reduce the recall bias and increase the accuracy of the description.
Numeric Pain Scale (NPS) for intensity of migraine
Time frame: Week 4
NPS was implemented in clinical practice due to its rapidity both verbally and in writing. Due to its convenience, it is common for hospitals to measure pain using the 0 to 10 NPS scale
Multidimensional Pain Inventory (MPI) for migraine impact
Time frame: Week 4
The MPI was administered pretreatment. It is a 61-item self-administered questionnaire composed of 12 empirically derived scales designed to measure a patients' experiences of pain, their spouses responses to their pain, and their general activity levels
1 secondary outcome
Migraine-Specific Quality of Life Survey (MSQ 2.1) for quality of life
Time frame: Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Background: PubMed 30291633Vukovic Cvetkovic V, Jensen RH. Neurostimulation for the treatment of chronic migraine and cluster headache. Acta Neurol Scand. 2019 Jan;139(1):4-17. doi: 10.1111/ane.13034. Epub 2018 Oct 29.
- Background: PubMed 29907608Tassorelli C, Grazzi L, de Tommaso M, Pierangeli G, Martelletti P, Rainero I, Dorlas S, Geppetti P, Ambrosini A, Sarchielli P, Liebler E, Barbanti P; PRESTO Study Group. Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study. Neurology. 2018 Jul 24;91(4):e364-e373. doi: 10.1212/WNL.0000000000005857. Epub 2018 Jun 15.
- Background: PubMed 30214271Lendvai IS, Maier A, Scheele D, Hurlemann R, Kinfe TM. Spotlight on cervical vagus nerve stimulation for the treatment of primary headache disorders: a review. J Pain Res. 2018 Aug 27;11:1613-1625. doi: 10.2147/JPR.S129202. eCollection 2018.
- Background: PubMed 30563446Martelletti P, Barbanti P, Grazzi L, Pierangeli G, Rainero I, Geppetti P, Ambrosini A, Sarchielli P, Tassorelli C, Liebler E, de Tommaso M; PRESTO Study Group. Correction to: Consistent effects of non-invasive vagus nerve stimulation (nVNS) for the acute treatment of migraine: additional findings from the randomized, sham-controlled, double-blind PRESTO trial. J Headache Pain. 2018 Dec 18;19(1):120. doi: 10.1186/s10194-018-0949-9.
- 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.
Mirza Obaid Baig, MSPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagal nerve stimulation in people with Migraine, run by Riphah International 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 1 inclusion and 1 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 19 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rabia Nasir, DPT (0092 331 9303051, Rabianasir123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structured Headache Diary Data for frequency of migraine (time frame: Week 4). 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 NCT06191016, which also lists 4 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 19 Jan 2024.