Transcutaneous Vagus Nerve Stimulation in Private Healthcare Center

NCT03440255 | Completed

• 1 other identifier: TaVNS_PHC
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This non-randomized, open-label study has the objective to study the effects and feasibility of Transauricular Vagus Nerve Stimulation (TaVNS) for patients suffering from Generalized Anxiety Disorder (GAD), Chronic Pain (CP) and Irritable Bowel Syndrome (IBS) in a private healthcare centre.

Conditions

Generalized Anxiety Disorder; Chronic Pain; Irritable Bowel Syndrome

Keywords

Transcutaneous Vagus nerve Stimulation; Generalized Anxiety Disorder; Chronic Pain; Irritable Bowel Syndrome; Private Practice

Outcome Measures

Primary Outcomes (3)

• Change from baseline generalized anxiety disorder severity

  To assess the response effect of the TaVNS on the severity of anxiety disorders measured by the 21 items self-administered Generalized Anxiety Disorder GAD-7 questionnaire, where scoring scores of 5, 10 and 15 represent cut-off points for mild, moderate and severe anxiety. A response will be considered as a reduced cut-off point from baseline.

  baseline, 4-week and 2-month follow-up

• Change from baseline pain severity and pain interference

  To assess the response effect of the TaVNS on the severity of pain and the impact of this pain on daily functioning (Interference) measured by the 9 items self-administered Brief Pain Inventory (Short Form) questionnaire; from 0 (no pain) to 10 (worst pain), ratings from 1 to 4 corresponded to mild pain, 5 to 6 to moderate pain, and 7 to 10 to severe pain with cut-off points being 4 and 6. Scoring pain severity is the mean of the total pain score out of 10. Interference from 0 (no interference) to 10 (completely interferes), rating mild (\<=5), moderate (6-7), and severe (\>= 8) with cut-off points being 5 and 7. Scoring the interference severity is the mean of the total Interference score out of 10. A response will be considered as a reduced cut-off point from baseline.

  baseline, 4-week and 2-month follow-up

• Change from baseline irritable bowels syndrome severity

  To assess the response effect of the TaVNS on the severity of irritable bowel syndrome measured by the self-administered Irritable Bowel Syndrome Severity Scoring System (IBS-SSS), where the maximum achievable score is 500. Mild, moderate and severe categories were indicated by scores of 75 to 175, 175 to 300 and \> 300 respectively, with cut-off points being 175 and 300. A response will be considered as a reduced cut-off point from baseline.

  baseline, 4-week and 2-month follow-up

Study Arms (1)

Transcutaneous Vagus Nerve Stimulation

EXPERIMENTAL

TaVNS 8 sessions, 30 min, 4 weeks GAD: 20 Hertz (Hz) - 80 microseconds (µs) CP: 5Hz-200µs IBS: 3Hz-250µs

Device: Transcutaneous Vagus Nerve Stimulation

Interventions

Transcutaneous Vagus Nerve Stimulation DEVICE

TaVNS will be applied by the TENS 7000 device. The stimulation was set according the group of treatment: (GAD: 20Hz-80µs), (CP: 5Hz-200 µs), (IBS: 3Hz-250µs). The current intensity was individually established under the pain threshold .The stimulus generates an continous asymmetric biphasic waveform. Ear clip electrodes were plugged in the concha area of the left ear. The stimulation will last 30 min per session (total=8)

Transcutaneous Vagus Nerve Stimulation

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range 20-65 years old
• Patient suffering from either Generalized Anxiety Disorder, Chronic Pain scoring and Irritable Bowel Syndrome from moderate
• Patients meet the scoring standard questionnaires: mild to severe
• Patient can understand and answer the questions
• Patient exhibits symptoms for at least six months

You may not qualify if:

• Reading difficulties
• Diagnosed left ear lesion
• Measured blood pressure under 100/60 with or without anti-high blood pressure medicine
• Active implant such as cochlear implant
• Wounds and skin disease in the left ear
• Recent head trauma or concussion
• Cardiac pacemaker
• Severe alcoholism
• Left cervical vagotomy
• Cholinergic or B blocking medicine
• Recreative drugs
• Diagnosed concomitant psychiatric comorbidity
• Diagnosed concomitant personal disorders
• Diagnosed pregnancy
• Diagnosed concomitant severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic infectious diseases uncompensated

Sponsors & Collaborators

• Kinesis Health Associates: lead

Study Sites (1)

Kinesis Health Associates

Dartmouth, Nova Scotia, B2Y 1C9, Canada

Location

Related Publications (7)

• Salim S, Chugh G, Asghar M. Inflammation in anxiety. Adv Protein Chem Struct Biol. 2012;88:1-25. doi: 10.1016/B978-0-12-398314-5.00001-5.

  PMID: 22814704 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

• Nagarajan L, Walsh P, Gregory P, Lee M. VNS therapy in clinical practice in children with refractory epilepsy. Acta Neurol Scand. 2002 Jan;105(1):13-7. doi: 10.1034/j.1600-0404.2002.00129.x.

  PMID: 11903103 BACKGROUND

• Trevizol AP, Taiar I, Barros MD, Liquidatto B, Cordeiro Q, Shiozawa P. Transcutaneous vagus nerve stimulation (tVNS) protocol for the treatment of major depressive disorder: A case study assessing the auricular branch of the vagus nerve. Epilepsy Behav. 2015 Dec;53:166-7. doi: 10.1016/j.yebeh.2015.10.002. Epub 2015 Nov 12. No abstract available.

  PMID: 26580212 BACKGROUND

• Napadow V, Edwards RR, Cahalan CM, Mensing G, Greenbaum S, Valovska A, Li A, Kim J, Maeda Y, Park K, Wasan AD. Evoked pain analgesia in chronic pelvic pain patients using respiratory-gated auricular vagal afferent nerve stimulation. Pain Med. 2012 Jun;13(6):777-89. doi: 10.1111/j.1526-4637.2012.01385.x. Epub 2012 May 8.

  PMID: 22568773 BACKGROUND

• Bonaz B, Sinniger V, Pellissier S. The Vagus Nerve in the Neuro-Immune Axis: Implications in the Pathology of the Gastrointestinal Tract. Front Immunol. 2017 Nov 2;8:1452. doi: 10.3389/fimmu.2017.01452. eCollection 2017.

  PMID: 29163522 BACKGROUND

• George MS, Ward HE Jr, Ninan PT, Pollack M, Nahas Z, Anderson B, Kose S, Howland RH, Goodman WK, Ballenger JC. A pilot study of vagus nerve stimulation (VNS) for treatment-resistant anxiety disorders. Brain Stimul. 2008 Apr;1(2):112-21. doi: 10.1016/j.brs.2008.02.001. Epub 2008 Mar 28.

  PMID: 20633378 RESULT

MeSH Terms

Conditions

Generalized Anxiety Disorder; Chronic Pain; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Pascal JD Grolaux, DO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 22, 2018
• Study Start: July 1, 2017
• Primary Completion: July 31, 2017
• Study Completion: September 15, 2017
• Last Updated: February 22, 2018

Record last verified: 2018-02

Locations

CA (1)