None listed
Conditions
Brief summary
Cardiovascular disease is a major health problem and is a leading cause of death nationally and worldwide. Cardiovascular autonomic nervous system imbalance, characterised by excessive sympathetic and reduced parasympathetic activity is a hallmark of cardiovascular disease and is independently associated with morbidity and mortality. Parasympathetic nervous system regulation has to involve brain areas of the default mode network, specifically the posterior cingulate cortex. This pilot study investigates whether non-invasive neurofeedback training technique, targeted at the posterior cingulate cortex can improve cardiovascular autonomic nervous system function. Twenty healthy men will be randomised to either six sessions of neurofeedback or placebo over a two week period. Cardiovascular autonomic function testing with validated battery of tests which encompasses measurement of resting blood pressure, and heart rate and its variability, as well as their responses to breathing alterations and the Valsalva Manoeuvre. Brain activity will also be assessed using encephalogram. Questionnaires will be utilised to measure wellbeing and sleep quality. Assessments will be carried out before and after the first and sixth session of neurofeedback, and then one week following neurofeedback training. This is the first randomised trail investigating the effects of neurofeedback on the cardiovascular autonomic nervous system. If this pilot study shows positive finding, we will test the therapeutic potential of neurofeedback in patient cohorts with known cardiovascular disease risk and as a preconditioning tool in those who are to undergo surgery. This novel technique is not used in any other group in New Zealand. Neurofeedback has no known side-effects and is a promising non-pharmacological treatment therapy for a wide spectrum of individuals who are at risk of cardiovascular disease. Neurofeedback can be conducted using a reasonably low cost portable device and carried out by trained technicians in outpatient clinics. With further advances in technology, portable home-based systems are likely to be developed.
Interventions
20 healthy men between the ages of 18-64 years will be recruited from the community using advertisement in newspapers and on notice boards.
Those who are interested will be asked to attend a screening session at the clinic and will be provided with the participant information sheet. During this visit, consent will be obtained. The researcher will screen potential participants for eligibility. If eligible, the participant will undergo an electroencephalogram (EEG), cardiovascular autonomic nerv
20 healthy men between the ages of 18-64 years will be recruited from the community using advertisement in newspapers and on notice boards. Those who are interested will be asked to attend a screening session at the clinic and will be provided with the participant information sheet. During this visit, consent will be obtained. The researcher will screen potential participants for eligibility. If eligible, the participant will undergo an electroencephalogram (EEG), cardiovascular autonomic nervous system assessments (ANS) and fill out a battery of questionnaires. Subsequently, they will be randomised and will undergo either treatment infraslow (T-ISF)(n=10) or placebo infraslow (P-ISF) (n=10) for 6 sessions, This will be administered with 3 sessions during the first week, 2 sessions in the second week and 1 session in the third week. During the first session, the neurofeedback training will be for 10 minutes and the subsequent 5 sessions will be 20 minutes each. The duration for the first clinic session will take 30 mins while the other 5 sessions will take 45 minutes each. During each session, participants will be asked to sit in a chair in an upright position and relax for 5 minutes. After careful skin preparation, the appropriate Comby EEG cap will be placed on the participant's head with reference electrodes at the mastoids. The impedance of the active electrodes will be kept between 2 to 5 kilo-ohms. Before the training period, participants will be instructed to relax and listen to the sound being played. A distinct tone will be used for T-ISF reinforcement at the Posterior Cingulate Cortex (PCC). Reward threshold will be adjusted in real time at above 90%. In other words, for 90% of the time, a sound will be played (reward) when the participant's brain activity meets the infraslow magnitude (threshold). For P-ISF, the simulation protocol by Brainmaster Inc will be administered. Both T-ISF and P-ISF infraslow sLORETA neurofeedback will be implemented with a 24 channel DC coupled amplifier produced by Brainmaster Inc at the research clinic. During the training period, participants will be sitting upright in the chair with the infraslow Comby EEG cap attached. Throughout the sessions, participants will be asked to keep their eyes closed, relax and listen to the sound being played by the device. Infraslow training will be administered by a researcher who has undergone training by Brainmaster Inc. The researcher administering infraslow training will record the number of sessions attended. Primary and secondary outcomes will be assessed after the first neurofeedback session, after six sessions and two weeks after the last neurofeedback session. The researchers will compare baseline characteristics (wellbeing, psychological variables) of those who complete the study to those who did not. This will help inform the researchers on strategies to improve compliance if a larger clinical trial is to be conducted.
Sponsors
Professor Dirk De Ridder
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
1.Men aged 18-64 years and being right handed. For this pilot study we have pre-selected male participants because cardiovascular mortality is five times higher in men than in women across adulthood and the menstrual cycle is known to alter ANS function. 2. For this pilot study we have only included participants who are right handed as handedness affects the interpretation of electroencephalogram (EEG).
Exclusion criteria
Antidepressants and other psychotic medications; recent significant head injuries, psychiatric disorders, significant health problems (diabetes, cancer, heart disease, uncontrolled hypertension), history of epilepsy, metal implants or implanted pacemakers, recurring headaches.
Outcome results
None listed