Vagus Nerve Stimulation in Fibromyalgia

NCT06237595 | Unknown

• 1 other identifier: 492023
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Vagus nerve stimulation is thought to reduce sympathetic nerve outflow and so can improve sympathetic hyperactivity in fibromyalgia patients. We aimed in the current study, to evaluate the effect of the cervical transcutaneous vagus nerve stimulation in comparison to conventional medical treatment in Egyptian fibromyalgia patients.

Conditions

Fibromyalgia

Keywords

vagus nerve stimulation

Outcome Measures

Primary Outcomes (4)

• Visual analogue scale 0-10

  A 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme "worst pain imaginable". decrease i scale means improvement

  2 months

• Symptom severity scale score

  A 0-12 score denoting the severity of symptoms. decrease in the score means improvement.

  2 months

• Widespread pain index

  A 0 - 19 score denoting the number of areas the patient has had pain over the last week. decrease in value means improvement.

  2 months

• Fibromyalgia severity scale

  Is the sum of both widespread pain index, and symptom severity scale score. A decrease in value means improvement

  2 months

Secondary Outcomes (3)

• Beck anxiety scale

  2 months

• Beck depression inventory

  2 months

• Pittsburgh sleep quality index

  2 months

Study Arms (3)

1 Vagus nerve stimulation

ACTIVE COMPARATOR

The first group will receive cervical transcutaneous vagus nerve stimulation that will be carried out with a TENS device, using a small self-adhesive surface electrodes (1 cm diameter). The electrodes will be positioned on the surface of the neck that corresponds to the position of the left cervical branch of the vagus nerve, over the carotid pulse just medial to the sternocleidomastoid muscle (Molero-Chamizo et al., 2022) using a biphasic, asymmetrical waveform with a pulse duration that is less than 250 microseconds and a frequency of 20 hertz. Intensity is adjusted according to the sensory threshold level of each patient, each session lasts for 30 minutes (Kutlu et al., 2020). All patients will receive 3 sessions per week for a total of 12 sessions, The sessions will be carried on at Department of Rheumatology and Rehabilitation, Cairo University Hospital

Device: Vagus nerve stimulation

2 Medical treatment

ACTIVE COMPARATOR

This group will receive medical treatment in the form of: Gabapentin 300 mg capsule once at night, and Duloxetine 30 mg cap once daily for 30 days.

Drug: Medical treatment

3 Combined vagus nerve stimulation and medical treatment

ACTIVE COMPARATOR

This group will receive cervical t-VNS in the same protocol like the vagus nerve stimulation group, in addition to medical treatment in the form of: Gabapentin 300 mg capsule once at night, and Duloxetine 30 mg cap once daily for 30 days.

Combination Product: Combined vagus nerve stimulation and medical treatment

Interventions

Vagus nerve stimulation DEVICE

Electrical stimulation of the vagus nerve.

1 Vagus nerve stimulation

Medical treatment DRUG

Medical treatment for fibromyalgia patients

2 Medical treatment

Combined vagus nerve stimulation and medical treatment COMBINATION_PRODUCT

Combination of the two interventions

3 Combined vagus nerve stimulation and medical treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: fibromyalgia is more common in females
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients above 18 years, with a clinical diagnosis of fibromyalgia according to 2016 ACR fibromyalgia diagnostic criteria, will be included in this study.

You may not qualify if:

• \- Pregnant, and postmenopausal women.
• Patients with any medical disorder including: cardiovascular, pulmonary, renal, hepatic, endocrine, blood, gastrointestinal, diabetes, neuropathic disorders, psychiatric disorders (for example; post traumatic stress disorder (PTSD), mania, psychosis, suicidality, bipolar/schizophrenia/autism spectrum disorders) and/or neurodegenerative disorders (e.g., Parkinson's, Alzheimer's, Huntington's disease).
• Cancer diagnosis within the preceding 5 years.
• Planned surgery.
• Use of other medical devices electrically active for example a cardiac pacemaker, or TENS for chronic pain.
• Electrocardiogram (ECG) abnormalities.
• History of Electroconvulsive therapy (ECT).
• Symptomatic orthostatic hypotension, or history of recurrent vagal syncope.
• History of vagotomy.
• Uncontrolled hypertension or hypotension.
• Documented sleep apnea.
• Other rheumatic diseases like (Rheumatoid Arthritis, Systemic lupus erythematosus, Seronegative spondyloarthropathies).

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Elainy Hospital

Cairo, 11562, Egypt

RECRUITING

Related Publications (5)

• Molero-Chamizo A, Nitsche MA, Bolz A, Andujar Barroso RT, Alameda Bailen JR, Garcia Palomeque JC, Rivera-Urbina GN. Non-Invasive Transcutaneous Vagus Nerve Stimulation for the Treatment of Fibromyalgia Symptoms: A Study Protocol. Brain Sci. 2022 Jan 12;12(1):95. doi: 10.3390/brainsci12010095.

  PMID: 35053839 BACKGROUND

• Kutlu N, Ozden AV, Alptekin HK, Alptekin JO. The Impact of Auricular Vagus Nerve Stimulation on Pain and Life Quality in Patients with Fibromyalgia Syndrome. Biomed Res Int. 2020 Feb 28;2020:8656218. doi: 10.1155/2020/8656218. eCollection 2020.

  PMID: 32190684 BACKGROUND

• Drewes AM, Brock C, Rasmussen SE, Moller HJ, Brock B, Deleuran BW, Farmer AD, Pfeiffer-Jensen M. Short-term transcutaneous non-invasive vagus nerve stimulation may reduce disease activity and pro-inflammatory cytokines in rheumatoid arthritis: results of a pilot study. Scand J Rheumatol. 2021 Jan;50(1):20-27. doi: 10.1080/03009742.2020.1764617. Epub 2020 Oct 13.

  PMID: 33047630 BACKGROUND

• Bonaz B, Picq C, Sinniger V, Mayol JF, Clarencon D. Vagus nerve stimulation: from epilepsy to the cholinergic anti-inflammatory pathway. Neurogastroenterol Motil. 2013 Mar;25(3):208-21. doi: 10.1111/nmo.12076. Epub 2013 Jan 29.

  PMID: 23360102 BACKGROUND

• Yuan H, Silberstein SD. Vagus Nerve and Vagus Nerve Stimulation, a Comprehensive Review: Part II. Headache. 2016 Feb;56(2):259-66. doi: 10.1111/head.12650. Epub 2015 Sep 18.

  PMID: 26381725 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Hadeel A Elegily, DR

  kasr Elainy Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hadeel A Elegily, dr

CONTACT

00201066496611; hadilalielegily@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal ivestigator

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: February 1, 2024
• Study Start: September 30, 2023
• Primary Completion: October 30, 2024
• Study Completion: February 28, 2025
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

EG (1)