None listed
Conditions
Brief summary
The autonomic nervous system is vital for regulating ‘automatic’ functions of your body such as heart rate, blood pressure and the release of hormones. It is generally composed of two main branches; the sympathetic (fight or flight) and parasympathetic (rest and digest) systems. An imbalance in these two systems is termed 'dysautonomia' and is associated with numerous diseases. Our research group is undertaking a clinical trial in healthy adults that will investigate the effectiveness of a novel type of therapy known as infraslow neurofeedback in the regulation of the autonomic nervous system. Infraslow neurofeedback is a completely non-invasive therapy whereby we monitor the brain’s electrical activity with a device called an EEG. Through real-time feedback, participants essentially learn to self-regulate their brain activity with the aid of ‘rewards’ in the form of pleasant sounds given when their brain displays the desired activity (i.e. less or more infraslow activity). This type of learning which incorporates immediate feedback and positive reinforcement is known as operant conditioning. By teaching people to self-regulate the activity of very specific regions of the brain involved in controlling their autonomic nervous system, our hope is that we will see an improvement in the balance between the sympathetic and parasympathetic branches. As far as we know, we are the first in the world to study the potential effects of infraslow training on the autonomic nervous system.
Interventions
20 healthy men and 20 healthy women between the ages of 18-60 will be recruited from the from the community. Recruitment will be via advertisement on notice boards and in local newspapers over a 6 months period with an invitation to participate in a potential therapeutic method to modulate the ANS. Individuals who contact the researchers will be emailed an information sheet to read over before meeting the investigators. Individuals who show an interest will be asked to attend a screening sess
20 healthy men and 20 healthy women between the ages of 18-60 will be recruited from the from the community. Recruitment will be via advertisement on notice boards and in local newspapers over a 6 months period with an invitation to participate in a potential therapeutic method to modulate the ANS. Individuals who contact the researchers will be emailed an information sheet to read over before meeting the investigators. Individuals who show an interest will be asked to attend a screening session at the clinic of the University Hospital of Otago, Dunedin. Initially, potential participants will be assessed to see if they meet the inclusion criteria and do not have any existing exclusion criteria. Recruitment of participants will continue until the sample size of 20 for both men and women is achieved. Those who are eligible (n=20 men, n=20 women) will be randomised to either i) real infraslow neurfeedack (ISF; n=10 men, n=10 women) or ii) placebo ISF (P-ISF; n=10 men, n=10 women). Participants will receive a total of 6 sessions of ISF/P-ISF. An EEG and a battery of ANS assessments will be performed at screening (T0), prior to and following their first ISF/P-ISF session (T1) and last ISF/P-ISF session (T6), 1 week post ISF/P-ISF (T7), 1 month post ISF/P-ISF (T8) and 3 months post ISF/P-ISF (T9). In addition, all participants will fill out questionnaires and perform brief tests (i.e. Stroop tests) assessing various aspects of health including sleep, stress, well-being, affect and cognition (T0, T6, T7, T8 & T9). Furthermore, they will be asked to perform at-home collection of saliva samples on 2 consecutive weekdays following each ANS testing session (T0, T1, T6, T7, T8 & T9). Infraslow neurofeedback (ISF) is a non-invasive technique that measures brain activity using electroencephalogram (EEG) and generate a sound when your brain exhibits the targeted infraslow brain activity. EEG uses small electrodes or metal discs placed on scalp to measure, track and record changes in the brain’s electrical activity. Participants will complete a total of 6 ISF/P-ISF sessions. Training will be administered in a hospital setting by a doctor/researcher with prior experience and training delivering Brainmaster Inc. ISF/P-ISF training. There will be 3 sessions a week for 2 weeks. Each session will be 20 minutes with the exception of the first session which will be only 10 minutes. sLORETA ISF/P-ISF will be implemented with a 24 channel DC coupled amplifier produced by Brainmaster Inc. Training will be administered with participants sitting in a comfortable chair with their eyes closed. After careful skin preparation, the appropriate Comby EEG cap (Ag/AgCl) will be placed on the participant’s head with reference electrodes at the mastoids. The impedances of the active electrodes will be kept below 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 ISF reinforcement at the dorsal anterior cingulate cortex (dACC). 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). Prior to their first training session, a simple explanation will be given to participants. They will be informed that research has shown that attenuation of sympathetic nervous system activity may be of health benefit and that the sound they hear during ISF/P-ISF reflects whether they are doing well. There will be a total of 10 clinic visits in order to assess primary and secondary outcome measures both pre and post intervention. Sessions will run from 30 minutes to 2 hours depening on the assessments and interventions employed. Researchers will maintain contact via email throughout the trial to help ensure protocol adherence. A Case Report Form (CRF) will be used for the purposes of recording participant specific data including the number of sessions attended. The researchers will compare baseline characteristics between those who complete the trial and those who do not in order to help inform strategies for improved compliance in the event larger trials are performed.
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
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men and women aged 18-60 years. With respect to our female participants, only women currently using monophasic hormonal contraception will be recruited as hormonal fluctuations that occur during the menstrual cycle are known to alter ANS function. 2..Right handedness as handedness affects EEG interpretation.
Exclusion criteria
1. Certain medications (e.g. antidepressants and other psychotic medications) 2. Recent significant head injuries. e.g. concussion where consciousness is lost or surgery 3. Psychiatric disorders with psychotic symptoms or manic symptoms 4. Other health problems – diabetes, cancer, heart disease, uncontrolled hypertension 5. History of epilepsy 6. Metal implants or implanted electronics (pacemaker) 7. Recurring headaches 8. Currently pregnant
Outcome results
None listed