Twelve months, month by month
This page is for families on the Twelve Months track, and for anyone deciding whether to start it. It says what each stage usually feels like and what happens in it, in the order it happens. It is the same page for everyone, it stores nothing, and it is not medical advice. The programme itself is described on How to access tVNS, and the evidence on the Prader-Willi syndrome page.
One number matters more than any other on this page. In the one published series, the families who saw a change in outbursts saw it at about nine months, not at three. We say nine months is normal at every stage below, without apology, because months four and six are when it is hardest to believe.
Before day one: the baseline weeks
Four weeks of behaviour diary before the device arrives. We post you a printed diary after the suitability call: one line per outburst, with the time, what set it off, how long it lasted, and how intense on a scale of one to five. It is the format the families in the published series kept. No questionnaires.
The baseline is the comparison everything else is measured against, and it is the only thing that can show a change at month nine that is real rather than hoped for. Medication should be stable through these weeks.
The letter for the specialist team travels with the diary, for you to hand on. At the end of the baseline, not before, the deposit is taken and the device is dispatched so that day one falls on a Monday.
The first month
The box arrives with the device in the manufacturer's packaging, a welcome letter, a one-page first-evening sheet, a routine card, thirteen 28-day tick cards, spare silicone rings, and a change-signal card. Charge the stimulator, read the sheet, and leave the electrode in its box until the fitting call.
The fitting call is by video and takes thirty to forty-five minutes. We get the electrode sitting in the right place in the left ear, bring the intensity up to a clear, comfortable tingling and one notch back, starting low because sensory sensitivity is common in PWS. Then the practical part: the session goes into the person's daily schedule as a fixed item at a time you choose, paired with something they enjoy that only happens with the electrode in, and we choose the phrase for the change-signal card together. You get the skin-break number, and we pair the manufacturer's app if you want it.
The same evening, twenty minutes: electrode in, tick, out. That is day one. Then one hour twice a day for the first week, building to four hours a day by the end of week 2, in the sessions written on the routine card. The four hours can be split into shorter sessions; they should not be shortened.
What the first month usually feels like: the setting that felt strong on day one feels mild by day fourteen, and we reset it on the month 1 call. Some redness or itching at the ear is common and settles; check the ear each day for picking. The change-signal card is for the days the session has to move: show it as early as you can, say the phrase the same way each time, and put the session back in its usual place the next day.
After the month 1 call a refresh pack arrives: a fresh set of silicone rings, a new tube of cream, and a letter that says, for the first time in writing, that nine months is normal.
Two things do not wait: broken or sore skin at the ear means stop and call the skin-break number; dizziness, nausea, ringing in the ears or a change in heartbeat during a session means stop, let it pass, and call us before the next one.
Month 3
The first diary review, and no judgement yet. On the month 3 call we go through the diary together and fill in a one-page summary sheet for the specialist team: days used, usual hours, outbursts per week against the baseline, typical duration and intensity, side effects, and the questions you want to ask. You take it to the appointment. We hold no copy.
Nothing to see yet is what three months usually looks like, and we say so before you ask.
Month 4
A letter. Nothing to see yet is also what four months usually looks like. Four hours a day, at the time in the schedule, and the thing that only happens with the electrode in; if that thing has worn thin, swap it. The diary stays honest, one line per outburst, including the weeks that look no different from the baseline.
Month 6: halfway, and the four hours
The month 6 call, a letter, and a hand-signed postcard for the fridge. The letter is about one thing. In the published series, outbursts returned when sessions dropped from four hours a day to two, and month six is when families ease off, because six months of four hours is a long time and nothing obvious has happened yet. So: please keep to four hours a day. Splitting is fine; shortening is not.
On the call we fill in the second summary sheet for the team and confirm the date of the team appointment, which needs to fall before month 12 so that their view is in hand for the decision. Some families can see something by month 6; many cannot. Neither is the answer.
Month 9: the checkpoint
The point where the published series saw change, which is why the programme has a checkpoint here and not only at the end. A letter at the start of the month, then the month 9 call: we go through the diary with you and ask for your own sense of change, in your words, alongside the numbers. We fill in the month 9 summary sheet together.
If nothing has changed, that is information, not failure. It is not the answer either; the answer is at month 12, with the team's view. Between now and then, the same routine and the same four hours.
Month 12: the decision
We name the outcome plainly, as one of four, with the specialist team's view and your own side by side on the decision sheet in the diary:
- Responder. A documented fall in how often outbursts happen or how severe they are, against the baseline.
- Partial responder. A change that matters to you and the team, short of that threshold. In a household where outbursts drive placement decisions, a partial response may well be worth continuing; that is your call and the team's.
- Non-responder, with good use. No change, with sessions at or near four hours a day. A real answer.
- Adherence non-responder. No change, with sessions well below four hours a day. Not a treatment failure; the answer is not yet known.
None of the four is a wrong answer. Then the decision, which is yours and the team's: continue on the same routine, change something, or stop. Stopping has no taper and no withdrawal effect. If the answer is stop, the device goes back to us and we send the label the same day.
Afterwards
If you continue, pads and electrodes arrive on a consumables plan without you having to think about it, and we check in once a year. Anything about medication or, later, about reducing the hours belongs to the team, and we route it there.
If you stop, the return is as described on the programme page, and the diary stays yours.
Where to go from here
- Request a call to start. Nobody asks for money on the first call.
- How to access tVNS for the programme, the calls and what it costs.
- Prader-Willi syndrome for who it is for and what the evidence shows.
This page is for information only. It is not medical advice. Any decision about tVNS should be made with the person's clinical team, who know their full medical history.
tVNS is a Class IIa medical device manufactured by tVNS Technologies GmbH, Germany. Distributed in the UK by Anatomical Concepts UK Ltd.