Clinical trial · Interventional
MindVybe tVNS/APS for Wellbeing in Breast Cancer Survivors
An Open Label Study of Non-invasive Stimulation of Right and Left Auricular and Cervical Branches of the Vagus Nerve and Acupuncture Points Located on Both Earlobes Via Mindvybe Aimed at Improving Well- Being Disturbances Associated With Breast Cancer and Its Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study tests whether a gentle, non-invasive device called mindvybe can help improve feelings of wellbeing in people who have had breast cancer. Mindvybe delivers mild electrical stimulation near the vagus nerve (on the ears and neck) and to specific points on the earlobes. About 60 adults (ages 18-75) who finished breast cancer treatment within the past five years and still have ongoing wellbeing problems (such as low mood, stress, fatigue, or sleep issues) will take part. Participants will receive five 50-minute mindvybe sessions over one week. Researchers will measure changes in wellbeing, distress, fatigue, sleep, and heart-rate patterns before, during, and for up to 12 weeks after the sessions. The study is open-label (everyone receives the same treatment) and is considered low-risk.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transcutaneous vagus nerve and acupuncture point stimulation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- mindvybe tVNS/APS
- description
- Participants receive five 50-minute sessions of mindvybe™ over a 7-day period. mindvybe™ is a non-invasive device that delivers ultra-low-current electrical stimulation to the skin near the auricular and cervical branches of the vagus nerve and to acupuncture points on both earlobes.
- interventionNames
- Device: Transcutaneous vagus nerve and acupuncture point stimulation
Primary outcomes (1)
- measure
- Change in Psychological General Well-Being Index - Short Form (PGWB-S) Score
- timeFrame
- Baseline, after the fifth session (Day 7), and at 2, 4, 8, and 12 weeks after the final session
- description
- The PGWB-S is an 18-item self-report questionnaire that measures subjective psychological well-being and distress. Total scores range from 0 to 110, with higher scores indicating better well-being. The primary outcome is the change (improvement) in PGWB-S score from baseline (before the first session) to after the fifth session, and at follow-up time points.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Age 18 to 75 years Diagnosis of breast cancer with treatment completed within the past 5 years (chemotherapy and/or radiotherapy finished), or currently receiving chronic treatment for stage IV breast cancer Self-reported wellbeing disturbances related to breast cancer or its treatment Score of 6 or less on the life satisfaction, worthwhile, and/or happiness questions of the Office for National Statistics Four subjective well-being questions (ONS4) Able and willing to provide informed consent Able to attend five in-person sessions over a 7-day period and complete follow-up assessments - Exclusion Criteria: Age less than 18 years or greater than 75 years Known or suspected severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure) History of abnormal ECG (e.g., second- or third-degree heart block, atrial fibrillation, atrial flutter, recent ventricular tachycardia or fibrillation, or clinically significant premature ventricular contractions) Uncontrolled high blood pressure Known or suspected cerebrovascular disease Previous cervical vagotomy Current implantation of any electrical or neurostimulator device (including cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal cord stimulator, or cochlear implant) Metallic implant near the stimulation sites Pregnant, planning to become pregnant during the study period, or of childbearing potential and unwilling to use an accepted form of contraception Unable or unwilling to provide informed consent or comply with study procedures \-
References
Publications (0)
Data not yet available