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Completed

NCT Number: NCT01174498

Pilot Study of the Effect of Transcutaneous Stimulation of the Vagus Nerve on Pain Perception and Parameters of the Autonomic Nervous System

The increased incidence of pain syndromes requires the investigation of pathophysiological coherences as well as searching for new therapies. In the recent years neurostimulating techniques have been a promising approach regarding their analgesic effect. Combined with therapeutic standard procedures they can increase these effects and can have a positive impact on co-morbid diseases. The stimulation of the vagus nerve was proved as an efficient analgesic method in animal experiments and open clinical pilot studies amongst humans. Despite the lack of controlled approaches applying the method against defined pain syndromes, the stimulation of the vagus nerve has shown up as an effective method treating other psychiatric diseases like depression. The processing of stress, which is involved directly and indirectly in the pathogenesis of pain, seems to be susceptible for vagal stimulation. Compared with invasive methods the transcutaneous stimulation offers obvious advantages concerning appliance and occurrence of side effects. There are no studies so far dealing with the neuromodulatory effect on the handling of pain or the clinical therapy of defined (chronic) pain related diseases using the t-VNS system. The study hypothesis implies a change of experiencing pain when applying the t-VNS in healthy subjects.

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Key information

Conditions

Pain Bites and Stings Chemically-Induced Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Poisoning Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik und Poliklinik für Psychiatrie und Psychotherapie der Universität Regensburg

Regensburg, Bavaria, 93053, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age: Minimum: 18 years Maximum: no limit
  • Both Gender
  • Normal psychiatric medical history
  • Normal neurological report

Exclusion criteria

  • Psychiatric disease incl. pain-related diseases
  • Subject is on medication
  • Abuse of drugs or alcohol until 12 weeks before enrollment in the study
  • Actual wearing conditions
  • Pronounced lack of sleep within the last 2 days of enrollment
  • Excessive consumption of alcohol in the last 2 days
  • Peripheral neuropathy
  • Severe neurological diseases (cerebrovascular diseases, traumatic brain injury, epilepsy, Morbus Parkinson, dementia, systemic neurologic diseases etc.)
  • migraine
  • carpal tunnel syndrome or other entrapment syndromes
  • missing Informed Consent
  • Pregnancy
  • active implant (like cochlea implant, VNS, pacemaker)
  • severe internistic diseases (e.g. arterial hypertension, respiratory failure)
  • malignant diseases within the last five years
  • severe acute infections (e.g. HIV, hepatitis)
  • diseases of the ENT bodysystem: Hearing loss of the left ear which is treated with an hearing instrument, all dermatologic and infectious diseases which affect the area around the pinna and the ear canal
  • Other circumstances that in the opinion of the investigator might be an obstacle for enrolling the subject

Treatment and study plan

Cerbomed t-VNS® transcutaneous stimulation

Device

Subjects experience a transcutaneous, electrical, vagal stimulation with the t-VNS device.

Other names: Cerbomed t-VNS®

t-VNS Sham stimulation

Device

t-VNS Sham stimulation

Primary outcomes

  1. QST- Quantitative Sensory Testing

    Time frame: twice a day, two days in total

    measurement of pain with the qst method before and after the transcutaneous stimulation

Secondary outcomes

  1. Autonomic function measurement

    Time frame: once a day, two days in total

    assessed by skin conductance response (SCL), skin conductance reaction (SCR)

Sponsors and collaborators

Lead sponsor

cerbomed GmbH

Industry

Registry information

Official study title

Controlled, Randomized Study of Pain Perception and Psychophysiological Reactions of the Autonomic Nervous System Under Transcutaneous, Electrical Stimulation of the Vagus Nerve in Healthy Volunteers

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 3, 2010
Registry last updated
Mar 8, 2011

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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