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Completed

NCT Number: NCT03440255

Transcutaneous Vagus Nerve Stimulation in Private Healthcare Center

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.

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Chronic Pain Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kinesis Health Associates

Dartmouth, Nova Scotia, B2Y 1C9, Canada

About this study

The effects of TaVNS on GAD, CP and IBS. Participants were investigated during a 4-week period and a 2-month follow-up. Groups (GAD, CP, IBS) were assessed using questionnaires: Anxiety (Generalized Anxiety Disorder GAD-7); CP (Brief Pain Inventory Short Form Questionnaire) and IBS (Irritable Bowel Syndrome Severity Scoring System). TaVNS was performed using a standard transcutaneous electrical nerve stimulation (TENS) device and ear clip electrodes plugged into the concha area of the left ear. All participants received a bi-weekly 30 minutes stimulation (8 sessions). We defined three different TaVNS parameters for each group in hertz (Hz) and microsecond (µs), (GAD: 20Hz-80µs), (CP: 5Hz-200 µs), (IBS: 3Hz-250µs).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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)

Primary outcomes

  1. Change from baseline generalized anxiety disorder severity

    Time frame: baseline, 4-week and 2-month follow-up

    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.

  2. Change from baseline pain severity and pain interference

    Time frame: baseline, 4-week and 2-month follow-up

    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.

  3. Change from baseline irritable bowels syndrome severity

    Time frame: baseline, 4-week and 2-month follow-up

    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.

Sponsors and collaborators

Lead sponsor

Kinesis Health Associates

Other

Registry information

Official study title

Transcutaneous Vagus Nerve Stimulation (TaVNS) in Private Healthcare Center: An Open-Label, Non-Randomized Feasibility Study Targeting Anxiety, Chronic Pain and Irritable Bowel Syndrome

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 22, 2018
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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