All the study visits will take place at home.

You will meet with the study team via a video call using Microsoft Teams. If you prefer, you can be seen in person at the research site.

How long is the study for?

The study is around 8 months from your first visit with us.

The visits would be every few weeks for the first 10 weeks, then every couple of months for up to 8 months.

What happens in the study?

You will be randomly assigned to one of two groups. This is done randomly, like the toss of a coin, so that everyone has the same chance of being in either group.

If you are in the treatment group, you would receive active tDCS treatment for 10 weeks. In the control group, you would receive inactive tDCS treatment for 10 weeks. Studies show that most participants cannot tell whether they were having the active tDCS or the inactive device.

Each session is 30 minutes. There will be 5 sessions per week for the first 3 weeks, then 3 sessions per week for the next 7 weeks.

Each participant undergoes two EEG brain scans (optional) during baseline and week 10 study visits.

After the 10 weeks, you can decide if you want to continue with the tDCS stimulation until month 8. After the 10 weeks, everyone will be offered active tDCS treatment for 10 weeks. We will not know whether you have received the active or the inactive tDCS treatment until the end of the first 10 weeks of study.  

We will follow up with everyone in both groups at regular visits.

What is EEG?

EEG is the short form for electroencephalography. With EEG, we can tell which areas of the brain are active at particular time points.

EEG measures the electrical activity that brain cells generate.

When a group of brain cells activate together, they produce an electric field, which can be measured on the surface of the head. EEG is able to measure the activity from thousands of brain cells, which is called voltage.

EEG measures the electrical activity from brain cells using small metal discs, called electrodes, which are fitted within a cap over the head. The electrodes have to be in contact with the scalp in order to pick up the electrical activity.

Supervision and Assessment

You will be seen regularly by the same member of the study team as much as possible. We will show you how to use the tDCS device and we will support you if you experience any side effects.

We will also check in with you regularly to see how you are doing and ask about your mood and symptoms. You can contact us at any time if you have any questions or concerns.

Reimbursement

We will reimburse participants by vouchers for each visit. Participants will be reimbursed £20 in vouchers for each of the following study visits after randomisation: Baseline, weeks 1, 4, 7, 10 and month 8.

Participants who travel to the research centre will be reimbursed for their travel expenses, up to a total of £20 in vouchers per visit.

You will be reimbursed with a £30 voucher for your time for completing the EEG sessions (£15 each).

Participants will not be reimbursed for attending the screening visit and week 20 (end of open-label phase).