Vagal Nerve Stimulation and Pain Frequency, Intensity in Chronic Migraine

Migraine Clinical Trial

Official title:

Effects of Vagal Nerve Stimulation on Pain Frequency and Intensity in Chronic Migraine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06191016
• Other study ID #: REC01746 Rabia Nasir
• Status: Recruiting
• Phase: N/A
• Start date: December 26, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: January 2024
• Source: Riphah International University
• Contact: Rabia Nasir, DPT
• Phone: 0092 331 9303051
• Email: Rabianasir123[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: October 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic migraine (headache for 15 or more days/month for more than three months), Migraine with/without aura

Exclusion Criteria:

• Mental illness, Photophobic individual, Presence of shunt and/or implant at the cranial region

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Device:
• Vagal nerve stimulation
Experimental group will receive noninvasive vagal nerve stimulation (nVNS) in addition to prescribed medications
• Sham vagal nerve stimulation
control will receive sham stimulation to vagal nerve along with prescribed medications

Locations

Country	Name	City	State
Pakistan	Pakistan Railway General Hospital	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

Lendvai 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. — View Citation

Martelletti 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. — View Citation

Tassorelli 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 4
Primary	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	Week 4
Primary	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	Week 4
Secondary	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.	Week 4