None listed
Conditions
Brief summary
Depression is a global health issue. Many patients do not respond to existing drug and/or talking therapies. This study will confirm if neurofeedback training with scalp recorded EEG improves symptoms of depression. We will also use machine learning techniques to identify new EEG signals optimized for brain training. Before the start of brain training, volunteers will attend a session where we record their EEG while they are in a restful state. They will also fill in questionnaires that will ask them about their mood and personality on a computer. We will analyze the brain activity with machine learning. Volunteers who are able to commit to the brain training will move on to the next part of our study. For the brain training part of our study, volunteers will attend 3 neurofeedback training sessions a week (up to 75 minutes), for 3 months. Neurofeedback training involves playing a computer game to use mental activity to control either a flat screen display or sounds. The display/sound changes, in real time, with changes in participants’ brainwaves. Such feedback helps the participants learn to regulate their mental activity. If the mental activity successfully changes the brainwaves in the desired direction (thought to relieve depressive symptoms), participants will be rewarded with points. No points are taken off for changes in the opposite direction. We hypothesize that neurofeedback training to change brainwave activity in the desired direction will reduce the symptoms of depression. The results of our neurofeedback study will increase the options for treating depression.
Interventions
1. Name: Improving depression with neurofeedback training.
2. Why are we running the experimental trial?
We want to find out if neurofeedback training can reduce depression. We also want to know if a computer process called ‘machine learning’ can find new brain activity patterns linked to depression.
3. What does it involve?
Screening. We need a specific kind of person for the study. To decide if you fit our needs, you need to fill in an online screening form (please allow 20 minutes). This
1. Name: Improving depression with neurofeedback training. 2. Why are we running the experimental trial? We want to find out if neurofeedback training can reduce depression. We also want to know if a computer process called ‘machine learning’ can find new brain activity patterns linked to depression. 3. What does it involve? Screening. We need a specific kind of person for the study. To decide if you fit our needs, you need to fill in an online screening form (please allow 20 minutes). This will ask you some questions: about the difficulties you are having; any help you have received; and about your mood, personality, physical health, age, gender, and contact details. You can access the information sheet on the study here https:// otago/qualtrics.com/nfdep/screen. After you have completed the form, we may invite you to a face-to-face interview (up to 1 hour) to confirm that you can take part in our experiment. Part 1: If you are invited and agree to join our trial, you will attend a 1 hour and 15 minutes session. We will record brain activity from your scalp while you remain in a restful state with your eyes alternately open and closed for 10 minutes. You will also answer questions about your mood and personality on a computer. We will analyze the brain activity with machine learning. Part 2: Next, you will attend 3 training sessions (up to 1 hour and 15 minutes) every week for three months (36 sessions in total) during which you will learn to use your mental activity to control a flat screen computer display. When your brain activity changes in a particular way, the display will change, in real time. This feedback will help you to learn to control your brain activity. Whenever your brain activity changes in the desired way, you will get a points reward in the computer game. Learning to change your brain activity like this is called ‘neurofeedback training’. You will also answer questions about your mood and well-being on a computer. 4.Who is running the trial? The trial will be delivered by experienced brainwave researchers but will also include research assistants and students gaining experience in research as part of their study program. 5. How is the brain training trial run? There are 36 sessions of brain training. You will be receiving training on two types of activity from your brain. Each session will provide feedback on one of two types of brainwave signal: an ‘active control’ and a ‘treatment’. We expect training with the active control to have neither good nor bad effects, and training with the ‘treatment’ to have good effects. Neither you nor the person testing you will be told which signal is being used when. This is called ‘double-blind’ testing. 6. What devices are involved? Part 1 : For the machine learning session, we will record EEG using the EEGO amplifier from ANT Neuro. You will wear a waveguard cap from ANT Neuro. The cap is like a comfortable swimming cap with thirty over tiny sensors attached to it. Part 2: For the neurofeedback training sessions, you will be fitted with the same type of EEG cap as above. EEG will be recorded from eight of the sensors with the BioRadio amplifier (Great Lakes Technology). EEG from some of these sensors control the neurofeedback stimuli that will be presented on a desk top computer screen. 7. Why are we using two different recording systems? In part 1 of the study, our aim is to use machine learning techniques to identify EEG signals associated with depression. We hope to find EEG signals that can be used in brain training to relieve the symptoms of depression. Machine learning requires more data for its analyses. This is why we are using the EEGO amplifier, which allows us to recording EEG from a large number of scalp sites. For the same reason, we need a larger number of participants for part 1 of the study. We will separately recruit more participants for the machine learning part of the study. 8. How long is the 'wash out' period in the neurofeedback training experiment? The 'wash out' period is between 1 to 5 days.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria - above 18 years old who are willing to try an experimental treatment. - if already receiving help, the kind of help (e.g., doses, medicines and talking therapy) received needs to have been unchanged, for at least 6 weeks before and during the study so that we know reaction to it is stabilized. - be able to come to all the study appointments
Exclusion criteria
Exclusion criteria - has a mental illness besides major depressive disorder with or without comorbid anxiety disorder. - is highly suicidal. - has treatment-resistant depression. - has current or past brain lesions. - has a history drug abuse including drinking alcohol (more than 3 standard drinks per day or some alcohol everyday). - uses antipsychotics, anxiolytics or mood stabilizers except if part of ongoing treatment for depression/anxiety - suffers from serious physical disease such as heart and lung disease, influenza, diabetes and acute infections - is recovering from an accident, injury or operation. - has insufficient command of English or understanding of the study. - has a history of seizures; susceptibility to photosensitivity; or a history of allergic skin reactions. - is left-handed or ambidextrous.
Outcome results
None listed