None listed
Conditions
Brief summary
Vagal nerve stimulation is a noninvasive tool to improve mental health. vagal nerve stimulation uses a device that is attached either to the ear or held at the neck that emits a very low electrical pulse, which stimulates the nerve. Participants use this in the clinic for up to 30 minutes to improve physical and mental health.The study aims to compare a four week trial using VNS to treatment as usual using traditional biofeedback. The hypothesis is that vagal stimulation has a similar outcome to treatment as usual but requires less active participation by the patient
Interventions
The VNS Therapy Aspire HC Pulse Generator Model 105 is approved by the TGA for vagal transcutaneous nerve stimulation (VNS). The current study uses a dose of 1.25-1.5 mA; 250 microsec applied under the pain threshold to the ear or at the neck by the clinical scientist who has experience in biosignal processing. Intervention is twice per week at the clinic when participants attend for their therapy over a four week period as recommended by distributor and scientific literature.Physiological resp
The VNS Therapy Aspire HC Pulse Generator Model 105 is approved by the TGA for vagal transcutaneous nerve stimulation (VNS). The current study uses a dose of 1.25-1.5 mA; 250 microsec applied under the pain threshold to the ear or at the neck by the clinical scientist who has experience in biosignal processing. Intervention is twice per week at the clinic when participants attend for their therapy over a four week period as recommended by distributor and scientific literature.Physiological response to VNS will be measured with a Thought Technology Infinity 5 system that measures heart rate, respiratory rate, skin conductance, EMG and temperature. Measures will be undertaken prior to commencing with intervention and post 4 weeks of intervention. These physiological responses will also be recorded during each session. In addition the Beck Depression questionnaire and general anxiety questionnaire as well as the PCL 5 will be included to assess psychological benefits. EEG will be used to determine any changes in brain networks using the EEGer V4 system with electrodes placed at Fz, Cz, Pz, F2, F3, T3 and T4. There are two groups of participants recruited (power analysis for a two group comparative design requires 41 participants in each group) to be confident that a difference between the two groups can be observed if present. The VNS group will receive VNS as part of the biofeedback intervention, whereas the control group will receive biofeedback through either heart rate variability or EMG feedback, which constitutes treatment as usual. HRV and EMG biofeedback combined with diaphragmatic breathing also affects vagal nerve function and improves mental health. Diaphragmatic breathing requires breathing cycles of 10 sec, breathing in through the nose and out through the mouth. Participants are instructed to allow the abdomen to exand rather than the chest when breathing. Both groups will be required to undertake diaphragmatic breathing twice per day as home practice for 10 to 20 minutes each time during the trial. Adherence wil lbe recorded by a home diary. Each session at the clinic will be approximately 45 minutes, constituting participant review and up to 30 minutes of either heart rate or EMG biofeedback or vagal nerve stimulation depending on which group the participant was randomly selected to.
Sponsors
Charles Sturt University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age greater than 18 years of age, presenting as patient at psychiatric clinic.
Exclusion criteria
People with Alzheimer's disease or Parkinson's disease as well as severe psychosis will be excluded
Outcome results
None listed