Neurofeedback

As non-pharmacological, non-invasive and painless brainwave technique, NF contributes to teach individuals how they can take the control of their mind through operant conditioning. Although a universally accepted neurofeedback protocol for smoking cessation therapy is not yet established, several studies employing real time fMRI (rtfMRI) revealed that reductions in ACC’s activity and craving have been observed across three rtfMRI visits. The expertise in the consortium will allow us to use the information from the fMRI studies in order to target the relevant brain structures via typical EEG neurofeedback, and standarize a convenient protocol for smoking cessation.

Despite enormous promise, the current status of NF makes it difficult to recruit participants’ individually and even more so to use NF as a smoking cessation treatment. To remove these obstacles a series of protocols are needed that are personalized to the needs of individuals and are based on scientific evidence (for example which brain areas are involved and how) that can be used for evaluating their efficacy and hence maximize their utility as their use increases. Recent studies show that the effectiveness of NF is inversely correlated to the severity of smoking dependence: NF is more successful for smokers with lower dependence compared to highly dependent smokers. Our project will provide solid neuroscience based information about NF and collate information about the local and national variants of the targeted population levels providing results on the effectiveness of NF technique for smokers with different dependence allowing for proper evaluation of NF as a smoking cessation treatment.

However, the fact that NF constitutes a painless, natural and non-invasive brainwave technique with no side effects might increase the project’s enrollment motivation. Therefore, the high adherence to NF approach is considered to facilitate the handling of smoking withdrawal symptoms and consequently prevent indirectly the extent of lung diseases induced by smoking. Furthermore, priory engaged local, national and European stakeholders and policy makers dealing with public health and prevention of lung diseases will be fully informed of the proposed protocol’s results facilitating the dissemination of an innovative smoking cessation treatment at local, national and European level.

NF regulates brain function in natural way. Studies have reported an 80% rate of reducing or eliminating the need for traditional medication. Therefore, other nicotine substitutes (such as the electronic cigarette) which may carry their own toxicity risk factor may become redundant. Additionally, a study exploring the economic burden induced by tobacco consumption in the United States reported that approximately 150 billion dollars are sacrificed to both medical care coverage and lost productivity related to smoking. Considering that an important barrier constitutes the cost of smoking cessation related medications and programs, the proposed work will include cost-effective in the long run in the overall NF protocol design.The NF approach could have numerous applications in different socioeconomic groups such as adolescents derived from families with different socioeconomic status and individuals with different cultural background in order to examine whether the cultural aspect affects the extent of protocol’s efficacy or not. The results of the proposed NF protocol will be presented in collaborating local, national and European agencies and policy makers dealing with public health such as the Ministry of Health.

The proposed action will evaluate the effectiveness of an innovative NF protocol in specific vulnerable target populations such as the young unemployed smokers, asthma and COPD patients. Although tobacco consumption in these groups has found not to be affected by gender differences, the division of the research sample by gender, will allow the detailed study of the gender-based efficacy of the proposed protocol.

General Scope of Neurofeeback Sessions

The scopes of SmokeFreeBrain’s Neurofeedback pilot are first, to test existing protocols and develop and experimentally evaluate the efficiency of a new NF training protocol for smoking cessation. Second, to understand the underlying changes in neural networks at a fundamental level via the detailed analysis of data collected during NF. Finally, to use the new understanding to optimize the NF protocol for each individual. An integrated NF training protocol will be developed, as a smoking cessation aid, which will incorporate both biofeedback and NF techniques. This protocol will be based on previously published trainings such as the Peniston – Kulkosky protocol and its modifications that show promising clinical outcomes. The proposed protocol is expected to induce improvements on personality and behavior traits that will provide a valuable aid for smoking cessation.

Pilot in Greece

The primary objective of the pilot will be to investigate the efficacy of combined skin temperature Biofeedback and Alpha-Theta brainwave Neurofeedback up-training intervention in Smoking Cessation, while the secondary objective will be to investigate the efficacy of the combined skin temperature Biofeedback and Alpha-Theta brainwave Neurofeedback up-training intervention in increasing quality of life, general health, and self-esteem and reducing depression, anxiety and stress levels.

Where it is going to take place

Four electroencephalographic measurements will take place: one before the initiation of the treatment, one after 2-3 weeks, one at the end of the treatment and one as a follow-up, 6 months after the initiation of the treatment. All of these measurements will take place in the Laboratory of Medical Physics, in the Medical School of the Aristotle University of Thessaloniki. The treatment consists of 5 biofeedback and 20 neurofeedback sessions that will all take place at the Neurofeedback Centre of Northern Greece, which is located at the centre of Thessaloniki (Agias Sofias 5).

Who can be involved?

Young unemployed smokers aged 18-35 are welcome to participate in the pilot study. Additionally C.O.P.D. and Asthma patients aged 35+ are also welcomed. Prior to the initiation of the treatment all participants will undergo a clinical evaluation at the Smoking Cessation Clinic of the Respiratory Failure Unit of the Papanikolaou hospital in Thessaloniki, or at the private practice unit of Dr. Chrysoula Kourtidou Papadeli. The initial procedure will also evaluate the eligibility of the participants.

What participants are going to do during the pilot? For how long?

All subjects will undergo a clinical psychometric and neuropsychological evaluation along with an Electroencephalographic (EEG) measurement at 4 time-points: before, during, after the application of the protocol and at a follow-up. The treatment protocol will consist of 5 sessions of skin temperature biofeedback and 20 sessions of a neurofeedback training protocol, each lasting 40 mins that will consist of Alpha-Theta ratio up-training.

The training will be provided two times per week, at the NGNC premises. The goal of the biofeedback training is to establish a volitional control over aspects of physiology previously held to be inaccessible to consciousness. Hence, via this process, our aim is to stabilize the physiological function and acclimatize the subject to the technique of self-control.

The aim of the neurofeedback training is to induce a brain state that is related to relaxation and serves as a protector against cravings related to addiction. This state is associated with a reverie and disidentification with problems, stress or traumatic experiences.

All participants who will successfully complete the aforementioned experimental procedure will undergo a Magnetic Resonance Imaging measurement that will be held in the university hospital AHEPA.

Benefits for the participants

The participants will have the chance to acquire increased medical care in relation to their attempt to quit smoking. Additionally, by taking part to the intervention, participants will learn how to establish a volitional control over aspects of brain and body physiology previously held to be inaccessible to consciousness. This will, in turn, constitute strong protector against stress and all stress-related health problems in their everyday life.

As NF is a totally non-invasive technique and the subjects will not forfeit any other medical treatment that would be recommended to them, no potential risk is foreseen.

Dates: pilot study duration

The duration of the intervention is 3 months. The initial clinical and electrophysiological measurements will take place one week prior to the initiation of the intervention and the follow-up will take place after 6 months of the initiation of the intervention, or 3 months of the end of the treatment.

The pilot will start on April 2016 until October 2017.

Get involved

Are you a smoker (at least 10 cigarettes/day and 10 packyears) with C.O.P.D., or asthma? Are you a young unemployed adult? Do you want to give up smoking? SmokeFreeBrain gives you the opportunity to join the pilot, Join us.

Pilot in Cyprus

The Pilot study scope

The Smoke Free Brain project aims at effective smoking cessation in individuals belonging to high risk groups such as unemployed young adults, patients with chronic obstructive pulmonary disease and asthma patients and the general population of low- and middle-income countries, through a multi-level interventions spectrum.

The primary objective of the work in Cyprus will be to investigate the efficacy of the Infra Low Frequency (ILF) and Alpha-Theta neurofeedback training intervention in smoking cessation.

The secondary objectives are:

  • Investigation of changes in electrical brain activity during the neurofeedback sessions and longitudinally as the neurofeedback sessions proceed
  • In parallel longitudinal changes (before, during and after the neurofeedback sessions) in resting state brain activity will be studied in an effort to identify objective biomarkers of brain activity changes that correlate, or even predict smoking cessation success.

Where it is going to take place

All the EEG recordings and neurofeedback sessions will be held in a dedicated space (the EEG lab) in the premises of AAI Scientific Cultural Services Ltd (AAISCS). The premises are located in the commercial center of Nicosia with easy access by public transport within Nicosia and beyond.

What participants are going to do during the pilot? For how long?

The project aims for 80 individuals to complete the protocol: 60 smokers (minimum number of cigarettes a day 10) and 20 in the control group. The majority of participants will be selected in the age group 18-35 years and preferably young and unemployed adults. Individuals from other age ranges and with limited employment are encouraged to express interest, but their selection is not guaranteed.

All smokers and some control subjects will receive neurofeedback sessions. Each smoker subject will receive 20 NF sessions, divided into 4 sets, with each set composed of 5 successive sessions. Each 5-session set will be defined by the type of to complete the protocol intervention and the placement of electrodes. If necessary and if feasible within the resource and time constraints of the project, we will increase the sample size to ensure we have enough numbers for good statistics for the evaluation of the efficacy of the intervention in general and for each of the different methods. We will aim in particular to match the numbers of subjects in the parts of the protocol that are comparable between the implementations at AAISCS and AUTH team.

The neurofeedback sessions in Cyprus will be similar but not identical to the ones in Thessaloniki. Both teams will use alpha-theta protocol but the electrode placements will not be identical. Also the initial 5 neurofeedback sessions will be temperature control for AUTH subjects and the Othmer bipolar infra-low training (ILT) in Cyprus. At least 30 subjects will receive 10 NF alpha-theta training sessions with similar enough protocol in the AAISCS and AUTH group for meaningful conclusions to be drawn by comparing the respective results.

Participants will also undergo EEG recordings before, during and after the neurofeedback sessions using some of the following 3 tasks: eye-state change task, music listening task and text reading task. In the eye-state change task, smoking-related images will be used.

For a subset of subjects (at least 12) we will also collect two longer resting state records using either afternoon nap (with EEG recordings) or evening sleep using actigraphy. As much as possible subjects with good sleep habits will be selected (e.g. for the afternoon nap, we will give preference to subjects that usually take an afternoon nap).

Benefits for the participants

The participation of the subjects in this research project may prove useful for the long-term course of their health. Their participation in neurofeedback sessions will contribute not only to their effort to stop the harmful habit of smoking, but also in maintaining the balance of various brain systems thereby improving both their physical and mental health. As these subjects will have a partial clinical, psychological, and neuroscientific evaluation, they will benefit from increased medical attention.

Dates: pilot study duration

The duration of the intervention is about 3 months. The initial contact and screening as well as the first collection of electrophysiological measurements will take place one week prior to the initiation of the intervention and the follow-up will take place after 6 months and a year after the initiation of the intervention.

The pilot will start on January 2017 until December 2017.

Get involved

If you are motivated to stop smoking, especially if you are a heavy smoker (>10 cigarettes daily), young and unemployed, you are welcome to join our journey to SmokeFreeBrain. Even if you don’t smoke but are interested in neurofeedback to help you improve performance and avoid harmful ways, please join us. Contact us at 22 460 228 or info@aaiscs.com. Details at www.aaiscs.com/nf.