Vagal Nerve Stimulation and Pain Frequency, Intensity in Chronic Migraine

NCT ID: NCT06191016

Last Updated: 2024-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-26

Study Completion Date

2024-10-31

Brief Summary

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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

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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

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Migraine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nVNS Group

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

Group Type EXPERIMENTAL

Vagal nerve stimulation

Intervention Type DEVICE

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

Sham vagal nerve stimulation

Intervention Type DEVICE

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

Sham Group

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

Group Type ACTIVE_COMPARATOR

Vagal nerve stimulation

Intervention Type DEVICE

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

Sham vagal nerve stimulation

Intervention Type DEVICE

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

Interventions

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Vagal nerve stimulation

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

Intervention Type DEVICE

Sham vagal nerve stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mirza Obaid Baig, MSPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Pakistan Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Rabia Nasir, DPT

Role: CONTACT

0092 331 9303051

Mirza Obaid Baig, MSPT

Role: CONTACT

00923332238706

Facility Contacts

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Rabia Nasir, DPT

Role: primary

00923319303051

Mirza Obaid Baig, MSPT

Role: backup

0092 333 2238706

References

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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.

Reference Type BACKGROUND
PMID: 30291633 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29907608 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30214271 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30563446 (View on PubMed)

Other Identifiers

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REC01746 Rabia Nasir

Identifier Type: -

Identifier Source: org_study_id

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