PainNCT01174498
Pilot Study of the Effect of Transcutaneous Stimulation of the Vagus Nerve on Pain Perception and Parameters of the Autonomic Nervous System
A study testing Cerbomed t-VNS® transcutaneous stimulation in people with Pain, run by cerbomed GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Cerbomed t-VNS® transcutaneous stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: Minimum: 18 years Maximum: no limit
- Both Gender
- Normal psychiatric medical history
- Normal neurological report
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik und Poliklinik für Psychiatrie und Psychotherapie der Universität Regensburg
Regensburg, Bavaria, 93053
About this study
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
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.
- Conditions
- Pain
- Being tested
- Cerbomed t-VNS® transcutaneous stimulation, t-VNS Sham stimulation
- Keywords
- discomfort, distress, hurt, sting
- Medical subject headings
- Pain, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerbomed t-VNS® transcutaneous stimulationDevice
Also called Cerbomed t-VNS®
Subjects experience a transcutaneous, electrical, vagal stimulation with the t-VNS device.
t-VNS Sham stimulationDevice
t-VNS Sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| t-VNS sytem Vagus stimulation | Active comparator | Subjects experience a transcutaneous vagal stimulation by the t-VNS device Receives: Device: Cerbomed t-VNS® transcutaneous stimulation |
| Sham transcutaneous stimulation | Sham comparator | Sham stimulation with an attached t-VNS device Receives: Device: t-VNS Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
QST- Quantitative Sensory Testing
measurement of pain with the qst method before and after the transcutaneous stimulation
Measured: twice a day, two days in total
Secondary outcomes (1)
Autonomic function measurement
assessed by skin conductance response (SCL), skin conductance reaction (SCR)
Measured: once a day, two days in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2010 (estimated)
- Study startNov 2009
- Primary completionJul 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- cerbomed GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174498
- Sponsor's protocol ID
- cMPsPAI01
- Status last verified
- Mar 2011
- First submitted
- 2 Aug 2010
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01174498
- Acronym / sponsor ID
- cMPsPAI01
- Conditions
- Pain
- Keywords
- discomfort, distress, hurt, sting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- cerbomed GmbHIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 3 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| t-VNS sytem Vagus stimulation | Active comparator | Device: Cerbomed t-VNS® transcutaneous stimulationSubjects experience a transcutaneous vagal stimulation by the t-VNS device |
| Sham transcutaneous stimulation | Sham comparator | Device: t-VNS Sham stimulationSham stimulation with an attached t-VNS device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: Minimum: 18 years Maximum: no limit
- Both Gender
- Normal psychiatric medical history
- Normal neurological report
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerbomed t-VNS® transcutaneous stimulationAlso: Cerbomed t-VNS®Subjects experience a transcutaneous, electrical, vagal stimulation with the t-VNS device. | Device | t-VNS sytem Vagus stimulation |
| t-VNS Sham stimulationt-VNS Sham stimulation | Device | Sham transcutaneous stimulation |
Primary outcome
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
1 secondary outcome
Autonomic function measurement
Time frame: once a day, two days in total
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerbomed t-VNS® transcutaneous stimulation in people with Pain, run by cerbomed GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QST- Quantitative Sensory Testing (time frame: twice a day, two days in total). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2011.