Vagal Nerve Stimulation and Pain Frequency, Intensity in Chronic Migraine

January 18, 2024 updated by: Riphah International University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nVNS Group
Experimental group will receive noninvasive vagal nerve stimulation (nVNS) in addition to prescribed medications
Device: Vagal nerve stimulation
Experimental group will receive noninvasive vagal nerve stimulation (nVNS) in addition to prescribed medications
Device: Sham vagal nerve stimulation
control will receive sham stimulation to vagal nerve along with prescribed medications
Active Comparator: Sham Group
control will receive sham stimulation to vagal nerve along with prescribed medications.
Device: Vagal nerve stimulation
Experimental group will receive noninvasive vagal nerve stimulation (nVNS) in addition to prescribed medications
Device: Sham vagal nerve stimulation
control will receive sham stimulation to vagal nerve along with prescribed medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 4
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
Week 4
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
Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Migraine-Specific Quality of Life Survey (MSQ 2.1) for quality of life
Time Frame: Week 4
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Mirza Obaid Baig, MSPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 26, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

December 19, 2023

First Submitted That Met QC Criteria

December 19, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC01746 Rabia Nasir

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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