Healthy Adultst-VNSextNCT02113306
Does Transcutaneous Vagal Nerve Stimulation Improves Fear Extinction in Humans
A study testing t-VNS in people with Healthy Adults, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
A recent study with rats showed that electrical stimulation of the vagus nerve (VNS) facilitates extinction of fear (Pena, Engineer, \& McIntyre, Biological Psychiatry, 2013). The hypothesized mechanism is that VNS both enhances memory consolidation (by increasing noradrenergic neurotransmission) and reduces anxiety… Read more about this study
- Who is it for?
- Ages 16 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- t-VNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2014to Dec 2015
- 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 16 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- healthy men and women aged 16 - 50 years
Who cannot join
- current or past psychiatric or neurological disorder
- use of psychopharmaca
- use of medication that affects autonomic nervous functioning (e.g., bèta-blockers)
- current cardiac or respiratory disorder
- pregnancy
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Faculty of Psychology and Educational Science
Leuven, 3000
Ilse Van Diest, PhD
Holly Miller, PhD
About this study
A recent study with rats showed that electrical stimulation of the vagus nerve (VNS) facilitates extinction of fear (Pena, Engineer, \& McIntyre, Biological Psychiatry, 2013). The hypothesized mechanism is that VNS both enhances memory consolidation (by increasing noradrenergic neurotransmission) and reduces anxiety (thus: preventing fear responses to the CS which may re-consolidate the fear memory). The effect was only apparent when VNS occurred during exposure of the fear conditioned stimulus (CS), and not when stimulation was given immediately following exposure. These results may have implications for the treatment of anxiety disorders in humans. However, until recently, the only means to investigate the effects of VNS on human fear learning would have required the invasive implantation of vagus nerve stimulators. This has fortunately changed, as a non-invasive transcutaneous VNS device has been approved for use in the E.U. for the treatment of psychological disorders.
This study proposes to use a t-VNS to investigate its effects on fear learning and extinction in (healthy) humans. Previous research has only investigated the effects it has on human mood and memory. The results obtained suggest that it reduces negative affect and enhances memory, findings which are consistent with those reported for rats. It is thus reasonable to expect that t-VNS will facilitate the extinction of fear in humans.
Read more
The present study aims to answer the following research questions:
Does t-VNS during extinction training:
- accelerates extinction curves
- reduces spontaneous recovery of previously extinguished fear
- reduce re-acquisition of fear
- reduce generalization of fear to other stimuli that resemble the CS+?
- facilitates the generalization of inhibitory learning to stimuli that resemble the CS-?
- Conditions
- Healthy Adults
- Being tested
- t-VNS, sham stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
t-VNSDevice
Also called NEMOS®, Cerbomed, Erlangen, Germany
The device that will be used is approved for systematic use by those with epilepsy and depression in the European Union. It has been used in studies of acute stimulation with healthy participants with no significant changes in heart rate or breathing (Kraus et al., 2007; Busch et al., 2013).
sham stimulationDevice
Also called NEMOS®, Cerbomed, Erlangen, Germany
electrodes will be put upside down
| Study group | Role | What they receive |
|---|---|---|
| t-VNS | Experimental | electrical stimulation of the concha of the ear
30sec trains of 0.25msec-duration monophasic square wave pulses at 25Hz, with a stimulation intensity not exceeding 0.5 mA Receives: Device: t-VNS |
| sham t-VNS | Sham comparator | Sham stimulation of the earlobe will be conducted by positioning the electrode upside down
30sec trains of 0.25msec-duration monophasic square wave pulses at 25Hz, with a stimulation intensity not exceeding 0.5 mA Receives: Device: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
fear response
startle blink EMG skin conductance response ECG respiration self-reports
Measured: 3 test days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Principal investigator, Ilse Van Diest, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Ilse Van Diest, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113306
- Sponsor's protocol ID
- t-VNS extinction
- Acronym
- t-VNSext
- Status last verified
- Apr 2014
- First submitted
- 10 Apr 2014
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Transcutaneous Vagal Nerve Stimulation Improves Fear Extinction in Humans
- ClinicalTrials.gov ID
- NCT02113306
- Acronym / sponsor ID
- t-VNSext / t-VNS extinction
- Conditions
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 14 Apr 2014 (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.
A recent study with rats showed that electrical stimulation of the vagus nerve (VNS) facilitates extinction of fear (Pena, Engineer, \& McIntyre, Biological Psychiatry, 2013). The hypothesized mechanism is that VNS both enhances memory consolidation (by increasing noradrenergic neurotransmission) and reduces anxiety (thus: preventing fear responses to the CS which may re-consolidate the fear memory). The effect was only apparent when VNS occurred during exposure of the fear conditioned stimulus (CS), and not when stimulation was given immediately following exposure. These results may have implications for the treatment of anxiety disorders in humans. However, until recently, the only means to investigate the effects of VNS on human fear learning would have required the invasive implantation of vagus nerve stimulators. This has fortunately changed, as a non-invasive transcutaneous VNS device has been approved for use in the E.U. for the treatment of psychological disorders.
This study proposes to use a t-VNS to investigate its effects on fear learning and extinction in (healthy) humans. Previous research has only investigated the effects it has on human mood and memory. The results obtained suggest that it reduces negative affect and enhances memory, findings which are consistent with those reported for rats. It is thus reasonable to expect that t-VNS will facilitate the extinction of fear in humans.
The present study aims to answer the following research questions:
Does t-VNS during extinction training:
- accelerates extinction curves
- reduces spontaneous recovery of previously extinguished fear
- reduce re-acquisition of fear
- reduce generalization of fear to other stimuli that resemble the CS+?
- facilitates the generalization of inhibitory learning to stimuli that resemble the CS-?
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| t-VNS | Experimental | Device: t-VNSelectrical stimulation of the concha of the ear 30sec trains of 0.25msec-duration monophasic square wave pulses at 25Hz, with a stimulation intensity not exceeding 0.5 mA |
| sham t-VNS | Sham comparator | Device: sham stimulationSham stimulation of the earlobe will be conducted by positioning the electrode upside down 30sec trains of 0.25msec-duration monophasic square wave pulses at 25Hz, with a stimulation intensity not exceeding 0.5 mA |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- healthy men and women aged 16 - 50 years
Key exclusion criteria (5 listed)
- current or past psychiatric or neurological disorder
- use of psychopharmaca
- use of medication that affects autonomic nervous functioning (e.g., bèta-blockers)
- current cardiac or respiratory disorder
- pregnancy
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 |
|---|---|---|
| t-VNSAlso: NEMOS®, Cerbomed, Erlangen, GermanyThe device that will be used is approved for systematic use by those with epilepsy and depression in the European Union. It has been used in studies of acute stimulation with healthy participants with no significant changes in heart rate or breathing (Kraus et al., 2007; Busch et al., 2013). | Device | t-VNS |
| sham stimulationAlso: NEMOS®, Cerbomed, Erlangen, Germanyelectrodes will be put upside down | Device | sham t-VNS |
Primary outcome
fear response
Time frame: 3 test days
startle blink EMG skin conductance response ECG respiration self-reports
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
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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.
Ilse Van Diest, PhD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing t-VNS in people with Healthy Adults, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Apr 2014. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilse Van Diest, PhD (+32 16 32 60 29, ilse.vandiest@ppw.kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fear response (time frame: 3 test days). 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 14 Apr 2014.