Stimulating Compassion UsingTranscutaneous Vagus Nerve Stimulation

NCT05441774 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-05-23

No results posted yet for this study

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. 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.

Conditions

  • Healthy Volunteers

Interventions

DEVICE

Active transcutaneous vagus nerve stimulation

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.

BEHAVIORAL

Active self-compassion imagery

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.

DEVICE

Sham transcutaneous vagus nerve stimulation

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.

BEHAVIORAL

Sham mental imagery

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.

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Sunjeev K Kamboj, PhD · UCL

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-27
Primary Completion
2023-03-15
Completion
2023-03-15

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05441774 on ClinicalTrials.gov