Vagal Nerve Stimulation and Pain Frequency, Intensity in Chronic Migraine

NCT06191016 | Unknown

• 1 other identifier: REC01746 Rabia Nasir
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine

Keywords

chronic migraine; vagal nerve stimulation; pain intensity and frequency

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Migraine-Specific Quality of Life Survey (MSQ 2.1) for quality of life

  Week 4

Study Arms (2)

nVNS Group

EXPERIMENTAL

Experimental group will receive noninvasive vagal nerve stimulation (nVNS) in addition to prescribed medications

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.

Device: Vagal nerve stimulation; Device: Sham vagal nerve stimulation

Interventions

Vagal nerve stimulation DEVICE

Experimental group will receive noninvasive vagal nerve stimulation (nVNS) in addition to prescribed medications

Sham Group; nVNS Group

Sham vagal nerve stimulation DEVICE

control will receive sham stimulation to vagal nerve along with prescribed medications

Sham Group; nVNS Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

RECRUITING

Related Publications (4)

• 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.

  PMID: 30291633 BACKGROUND

• 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.

  PMID: 29907608 BACKGROUND

• 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.

  PMID: 30214271 BACKGROUND

• 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.

  PMID: 30563446 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Pain

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Mirza Obaid Baig, MSPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rabia Nasir, DPT

CONTACT

0092 331 9303051; Rabianasir123@gmail.com

Mirza Obaid Baig, MSPT

CONTACT

00923332238706; obaid.baig@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: December 26, 2023
• Primary Completion: September 30, 2024
• Study Completion: October 31, 2024
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)