Transcutaneous Vagus Nerve Stimulation in Private Healthcare Center

K

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

  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems