Pilot Study of the Effect of Transcutaneous Stimulation of the Vagus Nerve on Pain Perception and Parameters of the Autonomic Nervous System
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pain |
Device: Cerbomed t-VNS® transcutaneous stimulation Device: t-VNS Sham stimulation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official 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 |
- QST- Quantitative Sensory Testing [ Time Frame: twice a day, two days in total ] [ Designated as safety issue: No ]measurement of pain with the qst method before and after the transcutaneous stimulation
- Autonomic function measurement [ Time Frame: once a day, two days in total ] [ Designated as safety issue: No ]assessed by skin conductance response (SCL), skin conductance reaction (SCR)
| Estimated Enrollment: | 48 |
| Study Start Date: | November 2009 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: t-VNS sytem Vagus stimulation
Subjects experience a transcutaneous vagal stimulation by the t-VNS device
|
Device: Cerbomed t-VNS® transcutaneous stimulation
Subjects experience a transcutaneous, electrical, vagal stimulation with the t-VNS device.
Other Name: Cerbomed t-VNS®
|
|
Sham Comparator: Sham transcutaneous stimulation
Sham stimulation with an attached t-VNS device
|
Device: t-VNS Sham stimulation
t-VNS Sham stimulation
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Chief Medical Officer, cerbomed GmbH |
| ClinicalTrials.gov Identifier: | NCT01174498 History of Changes |
| Other Study ID Numbers: | cMPsPAI01 |
| Study First Received: | August 2, 2010 |
| Last Updated: | March 7, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by cerbomed GmbH:
|
discomfort distress hurt sting |
ClinicalTrials.gov processed this record on May 23, 2013