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Clinical Trials/NCT01174498
NCT01174498
Completed
Not Applicable

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

cerbomed GmbH1 site in 1 country48 target enrollmentNovember 2009
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
cerbomed GmbH
Enrollment
48
Locations
1
Primary Endpoint
QST- Quantitative Sensory Testing
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 2009
End Date
September 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
cerbomed GmbH

Eligibility Criteria

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.)
  • carpal tunnel syndrome or other entrapment syndromes
  • missing Informed Consent

Outcomes

Primary Outcomes

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

  • Autonomic function measurement(once a day, two days in total)

Study Sites (1)

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