Healthy VolunteersNCT05441774
Stimulating Compassion UsingTranscutaneous Vagus Nerve Stimulation
A study testing Active transcutaneous vagus nerve stimulation and Active self-compassion imagery in people with Healthy Volunteers, run by University College, London at 1 site in United Kingdom.
Trial summary
This experimental proof-of-concept study in healthy volunteers investigates whether a specific form of self-relating, namely, self-compassion, can be controlled through non-invasive stimulation of the vagus nerve. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Active transcutaneous vagus nerve stimulation and Active self-compassion imagery
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Jun 2022to 15 Mar 2023
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fluency in English
- Good (including corrected) vision and hearing.
Who cannot join
- Current use of any medication for a psychiatric condition
- Regular use of any medication used to treat a cardiovascular condition or inflammation
- Use of any illicit recreational drug >2/week
- Regularly consuming >14 standard UK 'units' of alcohol
- Currently receiving treatment for any mental health condition
- Scores on screening measures of depression (PHQ-2) and/or anxiety (GAD-2) that indicate significant levels of current/recent anxiety or depression (scores on either >4)
Show all 12Show fewer
- History of serious mental health problems (schizophrenia, bipolar disorder)
- Past or current cardiovascular or neurological problems
- Current/past problems related to chronic/recurring facial or ear pain
- Skin irritation/ broken skin at stimulation site
- Pregnancy or likelihood of becoming pregnant during study
- Previous adverse response to meditation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stimulating Compassion: Using Transcutaneous Vagus Nerve Stimulation (tVNS)
This experimental proof-of-concept study in healthy volunteers investigates whether a specific form of self-relating, namely, self-compassion, can be controlled through non-invasive stimulation of the vagus nerve. The vagus nerve is part of the parasympathetic nervous system (the 'rest and digest' system) and its fibers are spread throughout the upper body, face, and neck, including a branch that innervates parts of the external ear (e.g. the tragus), close to the surface of the skin. This allows the 'auricular branch' of the vagus nerve to be readily stimulated electrically. Importantly, this can be achieved non-invasively using a transcutaneous vagus nerve stimulation (tVNS) device. The investigators will test the effects of tVNS alone and in combination with a meditation-like technique that is intended to increase participants' feelings of self-compassion (self-compassion imagery). In particular, the investigators will assess participants' experience of self-compassion and self-criticism, as well as other outcome measures, before and during stimulation, and again after they perform the self-compassionate imagery exercise. These effects will be compared to three other groups: one that receives tVNS along with a control (sham) imagery procedure, another that receives sham tVNS and self-compassion imagery, and a final group that receives sham tVNS and sham imagery. It is expected that the group that receives active tVNS and the self-compassion imagery exercise will experience the largest average increases in self-compassion and decreases in self-criticism. The findings of this study will help us better understand the role of the vagus nerve in complex cognitive-emotional experiences - like compassion - and may also motivate the development of bioelectronic stimulation methods that can be used alongside psychological techniques for improving self-compassion and reducing self-criticism, particularly among people with certain psychological disorders.
Read the detailed description
The role of the vagus nerve in regulating cardiac, respiratory, and gut functioning via brainstem nuclei is well-established. More recently, its role has been examined in relation to the modulation of higher cognitive functions. Bodily signals (e.g. from the heart or gut) conveyed by vagal afferents could affect cognitive functioning via projections from the nucleus of the solitary tract (NTS) to the locus coeruleus and thence to widespread cortical areas through noradrenergic outputs. In addition, the NTS transmits sensory-visceral information to the central autonomic network, which includes higher brain areas (e.g. prefrontal cortex). Recent research suggests that vagus nerve activity is associated with a range of psychological functions including memory, executive function, and threat/fear processing. In addition, biobehavioral theories of vagal functioning, and emerging empirical evidence suggest a role for the vagus nerve in modulating social behavior as well as complex emotional states.
A number of researchers have proposed a role for vagal nerve functioning in well-being, and particularly in generating or modulating feelings of 'safeness', contentedness, and relaxation that underlie complex social-affective-motivational states, such as compassion. Previous research has examined the effects of inducing compassionate feelings while measuring vagus nerve activity (via heart rate variability). However, to our knowledge, no published study has demonstrated an association between vagal activity and compassion by directly modulating the vagus nerve itself. Such studies have important theoretical implications but are also potentially valuable in the future development of interventions that employ tVNS or similar technology to augment psychological treatments that employ compassion-focused techniques (e.g. compassionate mind training; compassion-focused cognitive therapy; loving-kindness meditation-based treatments, etc.)
The current experiment aims to determine if vagus nerve activation using tVNS is sufficient to generate positive affective states, especially compassion (specifically, self-reported self-compassion). Alternatively, tVNS may produce a permissive physiological context that facilitates compassionate responding. For example, tVNS may synergize the effects of a compassion-inducing behavioral intervention. To examine these possibilities, the investigators will test the separate and combined (interacting) effects of tVNS and a compassion-induction procedure (self-compassion mental imagery) compared to sham conditions, in a four-group factorial (2 x 2) design. Participants will be randomly assigned to (i) active tVNS + sham imagery, (ii) active tVNS + active self-compassion imagery, (iii) sham-tVNS + active self-compassion and (iv) sham-tVNS + sham imagery.
In addition to examining the effects of stimulation and imagery conditions on self-compassion, the investigators will also test their effects on other types of positive affect, as well as self-criticism, which is an opposing form of self-representation to self-compassion. Self-criticism is a transdiagnostic psychological marker of psychopathology, and measures of self-criticism are sensitive to the effects of compassion-focused interventions , including brief self-compassion imagery, as will be used here. Vagal activity will be indexed using heart rate variability, and effects of stimulation and imagery will additionally be tested on attentional bias (e.g. first fixation, increased dwell time) to compassionate facial expressions.
Participants attend two lab sessions (on Day 1 and 8) in which they will undergo either supervised active or sham tVNS and either the self-compassion or sham imagery exercise (delivered as standardized audio instructions), per their randomized condition. Assessments of heart rate variability, self-compassion, self-criticism, positive state affect, and state mindfulness will occur before stimulation, during stimulation, and after the imagery exercise. In addition, participants will complete the Day 1 stimulation procedure and imagery task on Days 2-7, guided via online audio and written instructions. This will allow us to test the effects of extended (daily) stimulation and imagery practice. Additional study details are available on the Open Science Framework (osf.io/k2dje).
- Conditions
- Healthy Volunteers
- Being tested
- Active transcutaneous vagus nerve stimulation, Active self-compassion imagery, Sham transcutaneous vagus nerve stimulation, Sham mental imagery
- Keywords
- Vagus nerve, Neurostimulation, Transcutaneous vagus nerve stimulation, Mental imagery, Compassion, Meditation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active transcutaneous vagus nerve stimulationDevice
Also called Parasym tVNS device
TVNS is a non-invasive counterpart to surgical methods for stimulating the vagus. For the active condition, stimulator electrodes deliver a mild electrical current to the tragus. Stimulation parameters: stimulation of left tragus via two gold-plated electrodes, attached by ear-clip. Waveform: rectangular, frequency: 20 Hz, pulse width: 0.2 ms, individually adjusted intensity based on participant's perceptual threshold.
Active self-compassion imageryBehavioural
Self-compassion imagery is both a meditative technique and a component of compassion-focused cognitive therapy. Here, self-compassionate imagery is delivered as standardized audio-recorded instructions.
Sham transcutaneous vagus nerve stimulationDevice
Also called Parasym tVNS device
TVNS is a non-invasive counterpart to surgical methods for stimulating the vagus. For the sham condition, stimulator electrodes deliver a mild electrical current to the earlobe. Stimulation parameters: stimulation of left earlobe via two gold-plated electrodes, attached by ear-clip. Waveform: rectangular, frequency: 20 Hz, pulse width: 0.2 ms, individually adjusted intensity based on participant's perceptual threshold.
Sham mental imageryBehavioural
Draw-a-face-in-imagination is the sham/ control imagery condition. Here, control imagery instructions are delivered as a standardized audio-recording, well-matched to self-compassion imagery for number of words, complexity of language, and duration of the audio instructions.
| Study group | Role | What they receive |
|---|---|---|
| Sham stimulation plus sham imagery | Sham comparator | Double sham group: Stimulator electrodes will be applied to earlobe (sham stimulation); imagery task will involve a 'draw-a-face-in-imagination' (sham imagery) task. Receives: Device: Sham transcutaneous vagus nerve stimulation; Behavioral: Sham mental imagery |
| Active stimulation plus sham imagery | Other | Single (imagery) sham group: Stimulator electrodes will be applied to the tragus (active stimulation); 'draw-a-face-in-imagination' (sham imagery) task. Receives: Device: Active transcutaneous vagus nerve stimulation; Behavioral: Sham mental imagery |
| Sham stimulation plus active self-compassion imagery | Other | Single (stimulation) sham group: earlobe (sham) stimulation; imagery task will involve directing compassion to the self (self-compassion, active imagery). Receives: Behavioral: Active self-compassion imagery; Device: Sham transcutaneous vagus nerve stimulation |
| Active stimulation plus active self-compassion imagery | Active comparator | Double active group: tragus (active) stimulation; self-compassion (active imagery) Receives: Device: Active transcutaneous vagus nerve stimulation; Behavioral: Active self-compassion imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
State self-compassion
Self-compassion subscale of the scenario-based self-compassion and self-criticism Scales (SCCS; Falconer et al, 2015). Score range: 15 (minimum) to 105 (maximum). High scores indicate greater self-compassion (desirable outcome)
Measured: 1 week
Heart rate variability
Root mean square of successive differences (commonly, RMSSD) between normal beats; high-frequency power. Higher levels indicate greater heart rate variability (a desirable outcome)
Measured: 1 week
State self-criticism
Self-criticism subscale of the SCCS (Falconer et al, 2015). Score range: 15 (minimum) to 105 (maximum). High scores indicate greater self-criticism (undesirable outcome)
Measured: 1 week
Secondary outcomes (4)
Eye-tracking attention metrics
Dwell time, first fixation and pupillometric indices of attentional bias to compassionate facial expressions (stimuli from Falconer et al., 2019). Faces differ in intensity (25%, 50%, 75%, 100% compassion) versus matched neutral expression.
Measured: 1 week
State mindfulness
5 items (2 body, 2 mind, and 1 activity-related mindfulness items) from the State Mindfulness Scale (Tanay \& Bernstein, 2013) as used by Shohan et al (2017). The range (average across items) is 1 to 5, with high levels indicating greater state mindfulness (desirable outcome).
Measured: 1 week
State positive and negative affect
Positive affects subscale of the International positive and negative affect schedule-SF (iPANAS, 10 item version; Thompson, 2007). Range of scores 5 (minimum) - 25 (maximum) for positive affect and 5-25 for negative affect, with higher scores indicating greater amounts of positive (desirable) and negative (undesirable) affect respectively.
Measured: 1 week
State positive affect (Safe/content)
Safe/content positive affect subscale of the Types of Positive Affect Scale (TPAS; Gilbert et al., 2008). Range of scores: 0 (minimum) -16 (maximum), with higher levels indicating greater levels of 'safeness'/contentedness (desirable outcome)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start27 Jun 2022
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Factorial
- Model description
- Factorial 2 (sham stimulation v active stimulation) x 2 (sham v self-compassion imagery)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunjeev K Kamboj, PhD, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441774
- Sponsor's protocol ID
- 07760/006
- Status last verified
- May 2023
- First submitted
- 23 Jun 2022
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request to PI
Publications
Kamboj SK, Peniket M, Simeonov L. A bioelectronic route to compassion: Rationale and study protocol for combining transcutaneous vagus nerve stimulation (tVNS) with compassionate mental imagery. PLoS One. 2023 Mar 13;18(3):e0282861. doi: 10.1371/journal.pone.0282861. eCollection 2023.
PubMed 36913378
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulating Compassion: Using Transcutaneous Vagus Nerve Stimulation (tVNS)
- ClinicalTrials.gov ID
- NCT05441774
- Acronym / sponsor ID
- 07760/006
- Conditions
- Healthy Volunteers
- Keywords
- Vagus nerve, Neurostimulation, Transcutaneous vagus nerve stimulation, Mental imagery, Compassion, Meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 1 Jul 2022 (actual)
- 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.
This experimental proof-of-concept study in healthy volunteers investigates whether a specific form of self-relating, namely, self-compassion, can be controlled through non-invasive stimulation of the vagus nerve. The vagus nerve is part of the parasympathetic nervous system (the 'rest and digest' system) and its fibers are spread throughout the upper body, face, and neck, including a branch that innervates parts of the external ear (e.g. the tragus), close to the surface of the skin. This allows the 'auricular branch' of the vagus nerve to be readily stimulated electrically. Importantly, this can be achieved non-invasively using a transcutaneous vagus nerve stimulation (tVNS) device. The investigators will test the effects of tVNS alone and in combination with a meditation-like technique that is intended to increase participants' feelings of self-compassion (self-compassion imagery). In particular, the investigators will assess participants' experience of self-compassion and self-criticism, as well as other outcome measures, before and during stimulation, and again after they perform the self-compassionate imagery exercise. These effects will be compared to three other groups: one that receives tVNS along with a control (sham) imagery procedure, another that receives sham tVNS and self-compassion imagery, and a final group that receives sham tVNS and sham imagery. It is expected that the group that receives active tVNS and the self-compassion imagery exercise will experience the largest average increases in self-compassion and decreases in self-criticism. The findings of this study will help us better understand the role of the vagus nerve in complex cognitive-emotional experiences - like compassion - and may also motivate the development of bioelectronic stimulation methods that can be used alongside psychological techniques for improving self-compassion and reducing self-criticism, particularly among people with certain psychological disorders.
Detailed description
The role of the vagus nerve in regulating cardiac, respiratory, and gut functioning via brainstem nuclei is well-established. More recently, its role has been examined in relation to the modulation of higher cognitive functions. Bodily signals (e.g. from the heart or gut) conveyed by vagal afferents could affect cognitive functioning via projections from the nucleus of the solitary tract (NTS) to the locus coeruleus and thence to widespread cortical areas through noradrenergic outputs. In addition, the NTS transmits sensory-visceral information to the central autonomic network, which includes higher brain areas (e.g. prefrontal cortex). Recent research suggests that vagus nerve activity is associated with a range of psychological functions including memory, executive function, and threat/fear processing. In addition, biobehavioral theories of vagal functioning, and emerging empirical evidence suggest a role for the vagus nerve in modulating social behavior as well as complex emotional states.
A number of researchers have proposed a role for vagal nerve functioning in well-being, and particularly in generating or modulating feelings of 'safeness', contentedness, and relaxation that underlie complex social-affective-motivational states, such as compassion. Previous research has examined the effects of inducing compassionate feelings while measuring vagus nerve activity (via heart rate variability). However, to our knowledge, no published study has demonstrated an association between vagal activity and compassion by directly modulating the vagus nerve itself. Such studies have important theoretical implications but are also potentially valuable in the future development of interventions that employ tVNS or similar technology to augment psychological treatments that employ compassion-focused techniques (e.g. compassionate mind training; compassion-focused cognitive therapy; loving-kindness meditation-based treatments, etc.)
The current experiment aims to determine if vagus nerve activation using tVNS is sufficient to generate positive affective states, especially compassion (specifically, self-reported self-compassion). Alternatively, tVNS may produce a permissive physiological context that facilitates compassionate responding. For example, tVNS may synergize the effects of a compassion-inducing behavioral intervention. To examine these possibilities, the investigators will test the separate and combined (interacting) effects of tVNS and a compassion-induction procedure (self-compassion mental imagery) compared to sham conditions, in a four-group factorial (2 x 2) design. Participants will be randomly assigned to (i) active tVNS + sham imagery, (ii) active tVNS + active self-compassion imagery, (iii) sham-tVNS + active self-compassion and (iv) sham-tVNS + sham imagery.
In addition to examining the effects of stimulation and imagery conditions on self-compassion, the investigators will also test their effects on other types of positive affect, as well as self-criticism, which is an opposing form of self-representation to self-compassion. Self-criticism is a transdiagnostic psychological marker of psychopathology, and measures of self-criticism are sensitive to the effects of compassion-focused interventions , including brief self-compassion imagery, as will be used here. Vagal activity will be indexed using heart rate variability, and effects of stimulation and imagery will additionally be tested on attentional bias (e.g. first fixation, increased dwell time) to compassionate facial expressions.
Participants attend two lab sessions (on Day 1 and 8) in which they will undergo either supervised active or sham tVNS and either the self-compassion or sham imagery exercise (delivered as standardized audio instructions), per their randomized condition. Assessments of heart rate variability, self-compassion, self-criticism, positive state affect, and state mindfulness will occur before stimulation, during stimulation, and after the imagery exercise. In addition, participants will complete the Day 1 stimulation procedure and imagery task on Days 2-7, guided via online audio and written instructions. This will allow us to test the effects of extended (daily) stimulation and imagery practice. Additional study details are available on the Open Science Framework (osf.io/k2dje).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Factorial 2 (sham stimulation v active stimulation) x 2 (sham v self-compassion imagery)
| Arm | Type | Receives |
|---|---|---|
| Sham stimulation plus sham imagery | Sham comparator | Device: Sham transcutaneous vagus nerve stimulation, Behavioral: Sham mental imageryDouble sham group: Stimulator electrodes will be applied to earlobe (sham stimulation); imagery task will involve a 'draw-a-face-in-imagination' (sham imagery) task. |
| Active stimulation plus sham imagery | Other | Device: Active transcutaneous vagus nerve stimulation, Behavioral: Sham mental imagerySingle (imagery) sham group: Stimulator electrodes will be applied to the tragus (active stimulation); 'draw-a-face-in-imagination' (sham imagery) task. |
| Sham stimulation plus active self-compassion imagery | Other | Behavioral: Active self-compassion imagery, Device: Sham transcutaneous vagus nerve stimulationSingle (stimulation) sham group: earlobe (sham) stimulation; imagery task will involve directing compassion to the self (self-compassion, active imagery). |
| Active stimulation plus active self-compassion imagery | Active comparator | Device: Active transcutaneous vagus nerve stimulation, Behavioral: Active self-compassion imageryDouble active group: tragus (active) stimulation; self-compassion (active imagery) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Fluency in English
- Good (including corrected) vision and hearing.
Key exclusion criteria (12 listed)
- Current use of any medication for a psychiatric condition
- Regular use of any medication used to treat a cardiovascular condition or inflammation
- Use of any illicit recreational drug >2/week
- Regularly consuming >14 standard UK 'units' of alcohol
- Currently receiving treatment for any mental health condition
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 |
|---|---|---|
| Active transcutaneous vagus nerve stimulationAlso: Parasym tVNS deviceTVNS is a non-invasive counterpart to surgical methods for stimulating the vagus. For the active condition, stimulator electrodes deliver a mild electrical current to the tragus. Stimulation parameters: stimulation of left tragus via two gold-plated electrodes, attached by ear-clip. Waveform: rectangular, frequency: 20 Hz, pulse width: 0.2 ms, individually adjusted intensity based on participant's perceptual threshold. | Device | Active stimulation plus active self-compassion imagery, Active stimulation plus sham imagery |
| Active self-compassion imagerySelf-compassion imagery is both a meditative technique and a component of compassion-focused cognitive therapy. Here, self-compassionate imagery is delivered as standardized audio-recorded instructions. | Behavioural | Active stimulation plus active self-compassion imagery, Sham stimulation plus active self-compassion imagery |
| Sham transcutaneous vagus nerve stimulationAlso: Parasym tVNS deviceTVNS is a non-invasive counterpart to surgical methods for stimulating the vagus. For the sham condition, stimulator electrodes deliver a mild electrical current to the earlobe. Stimulation parameters: stimulation of left earlobe via two gold-plated electrodes, attached by ear-clip. Waveform: rectangular, frequency: 20 Hz, pulse width: 0.2 ms, individually adjusted intensity based on participant's perceptual threshold. | Device | Sham stimulation plus active self-compassion imagery, Sham stimulation plus sham imagery |
| Sham mental imageryDraw-a-face-in-imagination is the sham/ control imagery condition. Here, control imagery instructions are delivered as a standardized audio-recording, well-matched to self-compassion imagery for number of words, complexity of language, and duration of the audio instructions. | Behavioural | Active stimulation plus sham imagery, Sham stimulation plus sham imagery |
Primary outcome
State self-compassion
Time frame: 1 week
Self-compassion subscale of the scenario-based self-compassion and self-criticism Scales (SCCS; Falconer et al, 2015). Score range: 15 (minimum) to 105 (maximum). High scores indicate greater self-compassion (desirable outcome)
Heart rate variability
Time frame: 1 week
Root mean square of successive differences (commonly, RMSSD) between normal beats; high-frequency power. Higher levels indicate greater heart rate variability (a desirable outcome)
State self-criticism
Time frame: 1 week
Self-criticism subscale of the SCCS (Falconer et al, 2015). Score range: 15 (minimum) to 105 (maximum). High scores indicate greater self-criticism (undesirable outcome)
4 secondary outcomes
Eye-tracking attention metrics
Time frame: 1 week
State mindfulness
Time frame: 1 week
State positive and negative affect
Time frame: 1 week
State positive affect (Safe/content)
Time frame: 1 week
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 23 May 2023.
- Derived from this study: PubMed 36913378Kamboj SK, Peniket M, Simeonov L. A bioelectronic route to compassion: Rationale and study protocol for combining transcutaneous vagus nerve stimulation (tVNS) with compassionate mental imagery. PLoS One. 2023 Mar 13;18(3):e0282861. doi: 10.1371/journal.pone.0282861. eCollection 2023.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request to PI
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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.
Sunjeev K Kamboj, PhD principal investigator
UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active transcutaneous vagus nerve stimulation and Active self-compassion imagery in people with Healthy Volunteers, run by University College, London at 1 site in United Kingdom.
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 2 inclusion and 12 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 23 May 2023. 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 United Kingdom. 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?
State self-compassion (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05441774, which also lists 1 linked publication.
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 23 May 2023.