Transcutaneous Vagus Nerve Stimulation in Private Healthcare Center

Kinesis Health Associates

Status: Completed

Conditions: Irritable Bowel Syndrome; Chronic Pain; Generalized Anxiety Disorder

Treatments: Device: Transcutaneous Vagus Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03440255

TaVNS_PHC

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 11 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Reading difficulties
2. Diagnosed left ear lesion
3. Measured blood pressure under 100/60 with or without anti-high blood pressure medicine
4. Active implant such as cochlear implant
5. Wounds and skin disease in the left ear
6. Recent head trauma or concussion
7. Cardiac pacemaker
8. Severe alcoholism
9. Left cervical vagotomy
10. Cholinergic or B blocking medicine
11. Recreative drugs
12. Diagnosed concomitant psychiatric comorbidity
13. Diagnosed concomitant personal disorders
14. Diagnosed pregnancy
15. Diagnosed concomitant severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic infectious diseases uncompensated

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Transcutaneous Vagus Nerve Stimulation

Experimental group

Description:

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

Treatment:

Device: Transcutaneous Vagus Nerve Stimulation