Thirteen patients with a mean age of 56.5 (SD 13.0; range 32-77 years) were interviewed. We excluded one patient because his memory deficits gave serious problems during the interview. All but three patients who were approached for an interview agreed to participate. Of these three patients, two could not participate due to logistic reasons and one felt uncomfortable with an interview because of aphasia. The majority of the patients were women (61.5%). The time post-stroke varied between 1 and 25 months. 61.5% had a right-sided hemiparesis. Characteristics of the patients are listed in Table 1.
The results are presented in two main sections. The first section describes the patient’s experiences with the treatment and presents the themes positive experiences with the treatment and concerns. During the interviews the patients also shared experiences about participation in an RCT, which are outlined in the themes experienced psychological effects and motivation to participate. An overview of the themes and subthemes is given in Table 2. Patient’s quotations are shown in italics, and interpretation of the patient’s words is presented alongside the quotations.
1. Patient’s experiences with the treatment
1.1 Positive experiences of the treatment
In general, patients had positive experiences receiving the rTMS treatment. Several patients mentioned that undergoing the treatment sessions felt as a special moment during their day: "For me it was... it sounds very silly... a getaway within my rehabilitation." (P5) In addition, a good vibe during the treatment sessions was emphasized by patients.
All patients would recommend participation in the intervention to other stroke patients. One patient expressed disappointment when the treatment sessions came to an end.
“I thought it was a pity that it was already over after ten times.” (P10)
1.1a Experienced physical effects
Some patients reported that the rTMS treatment had improved their arm function. On the contrary, some other patients reported that they were unable to indicate a cause of their recovery. They thought that a combination of participation in the trial, rehabilitation therapies and their own willingness to recover led to improvement. Two patients noted that they did not know the difference between what to expect and what not to expect in terms of recovery (e.g. spontaneous recovery).
Some patients were unable to identify any possible improvement. Those patients did not notice a difference in arm function, because of the TMS treatment.
“No, no not immediately. Maybe yes, of course you never know what the effect would be if you didn't do it. I have also noticed that with the medication that I take, since I’m tapering off, it suddenly gets very bad. So [the medication] did not lead to improvement, but if you do not take it, it affects you negatively. Perhaps that it also works that way for this [B-STARS intervention].” (P12)
Some patients express the difficulty of experiencing improvement when there is no comparison.
“I do not dare to say that. I don't know how to explain that. I got this [a stroke]. I don't know what it would be like if I hadn't done it. With or without [therapy], I don't have any comparison, so maybe it helped but maybe it did not.” (P9)
One patient stated that it was probably too early to speak about the results: “I think it's too early to judge." (P13)
A few patients reported no (long-term) improvements in arm function following the treatment.
Often patients reported their thoughts when they had sensations in the hand muscles in response to the pulses given to the head during determination of the resting motor threshold (RMT). Those sensations often gave rise to the idea that the treatment was ‘working’. The patients were aware that the determination of the RMT was not part of the treatment, but of the set-up phase.
1.1b Comfort
The treatment itself was described as a relaxed experience. Patients felt comfortable and were not nervous or anxious during the treatment sessions. Two patients described their voluntary participation in the trial.
“Yes, because otherwise you could have stopped it [treatment], if it became too much, but it didn’t.”
The comfort of the chair where they had to sit in was highly appreciated. The chair was experienced as very relaxing and some patients almost fell asleep in it. The calm environment without too many noises, and the calmness that the researchers radiated (e.g. by talking softly) seemed to contribute to the relaxed experience that patients had in the trial. A couple of patients described the pulses given on the head as a relaxing experience. One patient described it as follows:
"During the treatment I was very calm and strangely enough those pulses were calming and almost made me fall asleep." (P3)
1.1c Therapeutic relationship
All patients spoke highly of the research team that delivered the treatment. The researchers were seen as ‘polite’, ‘correct’, ‘friendly’ and ‘patient’. The human approach by the research team was experienced as comforting. For example, patients described that the researchers took their time in communicating with them and patients did not feel as a ‘number’. One patient was particularly pleased to receive attention that was specifically intended for him: the contact was more intimate.
Some patients expressed that they felt the researchers were grateful that they participated in the trial.
“And I have to say you were always very friendly. Grateful. I always consider that to be important. However, it is not a decisive factor, but it is always nice when you're finished and people are happy with what you have done. If you can help someone, why not.” (P12)
The attitude of the researchers was described as professional and trustworthy.
“No, because you appear so confident and reliable. You know what you are talking about, in my opinion, that is very obvious. Not like: ‘maybe when we try this or that’, then I would sense doubt. But, now it is clear what we are going to do and how we are going to do it.” (P7)
Within these narratives there is a strong sense of safety. One patient expressed appreciation for the communicated zero expectations from the researchers.
1.1d Receiving information
It was experienced that the research team gave clear information. Different aspects of information delivery were valued. One patient explained: “Just good information, normal answers, calmly - they take the time to explain it." (P2) Another said: “Everything was explained very neatly in regular Dutch language, the way I speak it.” (P7) Many patients commented on the explanation of every step during the treatment sessions.
“And they also said beforehand ‘we are going to do this now, we are doing that now, you will feel this right now.’ I also really like that.” (P13)
Knowing what to expect was emphasized as one of the reasons for the positive information exchange.
1.1e Learning about the brain
The muscle sensations of the pulses had a funny component for patients and made them more aware of the working of the brain.
“Well I didn’t find it exciting, scary or anything. Yes, really intrinsic interest in how the brain works and what is connected within your body.” (P10)
1.1f No burden of added TMS treatment session
All patients perceived participation in the daily treatment sessions as an element of their daily rehabilitation program.
“I was still in the middle of my rehabilitation process. So, then it's quite easy, like “okay it's an investigation”. At a certain point it was just scheduled in my day schedule, so it is just part of your day." (P12)
“A moment of relaxation! Hahaha, in here you walk from pillar to post and sometimes you have very intensive treatments and this - this was just a tranquil moment. You didn't have to do anything myself...” (P10)
The fact that they had a moment of relaxation and had the freedom to do nothing was appreciated by them.
Regarding the number of treatment sessions, patients indicated that if there had been a need from the trial or if it would have a (more) beneficial effect, they would have participated in more sessions. Patients also saw the treatment sessions as additional therapy: “The more [therapy], the better. Extra therapy, and just another step closer to perhaps an aid or an improvement, recovery.” (P12) The positivity around additional therapy (implicitly) reflects the patient’s belief that ‘more therapy is better outcome’. Some patients indicated that their daily program was quite busy, which caused fatigue, however the B-STARS did not cause additional fatigue.
1.1g No unpleasant aspects
Overall, the patients commented favorably on the painless aspect of the treatment: “Yes, because it didn't hurt either. See, if it hurts then it’s different, but ... it didn't hurt." (P4) Next to the painless treatment, the absence of negative consequences made them feel optimistic. One patient mentioned the non-invasive aspect of the brain stimulation. The pulses were often described by the patients in a neutral way or it was indicated that you had to get used to it.
1.2 Concerns
1.2a Effects of stimulation of the brain
Some patients initially felt a bit nervous or anxious before the start of the treatment sessions. Patients were concerned about the ‘electricity’ within the brain and were unsure whether there would be negative consequences for the brain from the brain stimulation.
“It did create some tension. Normally I am not a person who experiences tension that easily, but this created a bit of tension, because I still consider it [rTMS] as electronics, and it is my own brain. The most important part of your body, so to speak. And I was thinking: ‘I hope everything goes just right’.” (P7)
Some patients did not completely understand the relation between the diagnostic pulses and responses in one of the hand muscles during determination of the RMT, resulting in feelings of confusion.
“In the beginning I thought: ‘hey that stings’. You know. I could not immediately make the connection. Those shocks came and I thought ‘oooh, okay?’.” (P1)
Others reported feelings of annoyance caused by the pulses.
“Well at a certain point if you have to continue for longer, then you will get kind of tired of it. But it doesn't really hurt. You can feel it more clearly around your temples than on your head. But when they navigate more to your temples, then you feel it more clearly. But still it doesn't hurt or so. It's just a bit annoying. It is not really pleasant." (P2)
1.2b Equipment (chair and coil)
Most patients expressed concerns about the chair where they had to sit in during the treatment. Comfort during the treatment was experienced as important. One patient was hindered by lack of support from the head rest and arm rests being too small.
“If I would have designed [the chair] for the person lying in it… I would have provided more support at the bottom of the neck, which makes it more comfortable. And I would make the handrail 2 centimeters wider so it is easier to place your arm on it.” (P7)
Another patient said “The only downside I can mention is the chair in which I had to sit. I found it quite uncomfortable to sit back and then have to tilt my head back. Because of that chair, I was sitting in such a way that it wasn’t a pleasant position, so you kind of freeze in a very uncomfortable position.” (P8)
This patient also indicated that longer periods in the chair would not be feasible: "So it was good that it did not last any longer, because then I would not have been able to keep up with it." (P8) Other patients also found the chair uncomfortable, but were not bothered by it because they were in the chair for only a short time and understood that everyone should fit in the chair.
Two patients had specific concerns regarding the coil "Sometimes you just had an uncomfortable hairpin on your head, so sitting in the chair was a little less comfortable, but that's all I have to say." (P10), and glue from the electrodes: “I don't like the glue… I mean not removing it, because it isn’t a band-aid. It just remains sticky for a long time." (P5) used during the treatment sessions.
1.2c Logistics
Three patients expressed that ten treatment sessions are probably enough, since no recovery would be expected beyond those sessions, because they experienced no improvements in arm function during the intervention period. Or they indicated that the uncomfortable position in the chair would be a reason to exclude additional treatment sessions. One of them would not mind to receive fewer treatment sessions: “Shorter yes, but not longer.” (P1) Patients experienced little or no fatigue due to the format of the therapy, but did express that the full day program of rehabilitation caused fatigue or concerns from nurses about their program.
“The nursing staff gave me the impression that they thought that they thought it was a bit too much and a bit busy. But hey, according to me it fitted into my program and then you have to re-schedule a bit and it may mean that you had to take a shorter break occasionally.” (P10)
2. Participation in an RCT
2.1 General experience of recovery
The most commonly perceived changes after the treatment were improvements in arm function. In some cases, the patients described their improvements in comparison to their initial paresis or to other patients in the rehabilitation facility.
“It [arm, body] was no longer paralyzed on the right side." (P5)
"Yes! When I see people who also attend the hand therapy group, but don’t participate in the trial, I have made great progress.” (P3)
Some patients felt that the improvements had led to noticeable impacts on daily life activities. Activities and participation seem to be major factors in patient’s lives.
“[I] put on my socks, put on my shoes. This morning I showered myself. I just have to be careful not to slip, but I do everything by myself. Combing my hair is going okay, but this part of my hair is still difficult. And I am able to shave myself with a razor blade and shaving cream, and you see I made no cuts.” (P7)
“I can talk normally, I can walk, I am here by bike, I can drive, I can work, I can drink beers, hey I can basically do everything, except give people a good hand shake.” (P12)
In most cases, the patients noted specific improvements, as a return of strength and speed, improved fine motor skills, being able to move upper extremity elements and performing better at the motor function tests.
2.2 Experienced psychological effects
Experienced psychological effects (i.e. benefits and concerns) of participation in an RCT were often raised by the patients, which we divided in the subthemes ‘grateful’, ‘sense of purpose’, ‘recovery as a motivator’, and ‘group allocation’.
2.2a Grateful
Patients had the feeling to improve, and explicitly acknowledged the power of placebo-effect.
“Yes ... When I think it has worked, then it has worked. Yes, it's that simple. You are not sure whether it has worked, but as long as you think it has worked, then it will at least have that effect.”(P8)
It was evident in the transcripts that a number of patients felt gifted or as ‘being chosen’ when selected for the trial.
“I said now an angel should come to help me. And the door opens… and then actually a blonde angel comes in. And she asks if I want to participate in the program. I thought that must come from God, there is no other possibility. I am serious, it really experienced it that way. So, I told my wife that I should definitely participate, because there is no other way. So, it may sound strange, because I don't go to church or anything like that, but it really felt as a gift from God to me, and if I remember I might have said it too.” (P7)
2.2b Sense of purpose
Participating in the intervention gave almost all patients a sense of purpose. On one hand, patients had a sense of helping themselves, e.g. working for maximum recovery. “I wanted it to be as soon as over, you know. And yes, I just wanted to get rid of it as quickly as possible. And yes, then the best thing I can do is by participating." (P1) On the other hand, patients stated that their contribution might benefit and can create a better future for other stroke patients, and they found this rewarding. “I want to contribute to the research because it might help others. That is the only reason.” (P13) In addition to the sense of helping oneself and others, being able to contribute to science was also purposeful for many patients.
2.2c Recovery as extra motivation to exercise
Regardless whether patients improved because of receiving the rTMS treatment, noticing progress works as a great motivation. Performing the motor tests periodically, as part of their participation in the clinical trial, was appreciated by the patients. It felt like a feedback moment on the progress of their recovery, allowing improvement to be noticed by comparison with the previous performance on the test.
“So, then you notice that there is progress, I still have some progress so that also gives you motivation to continue.” (P11)
Those quotes hint at the possibility they were more willing to put more effort in their rehabilitation than before the improvements. For some patients experiencing recovery contributed to a more positive mindset and future.
"Yes! You get a kind of boost, because you hope that it will help. You go into your next rehabilitation [session]with a more pleasant and relaxed feeling. In your daily schedule, you might think ‘well, maybe it helps?’ You do take the positive feeling to the next one [session]." (P2)
One patient expressed to be proud on the improvements made this far: “And I have to admit I am very proud that it is going so well.” (P7)
2.2d Disappointment and hope of group allocation
A few patients indicated that allocation to the sham group would have disappointed them, suggesting that they were hoping for personal advantage. Despite the expressed disappointment of possible allocation to the control group, they did not drop out or refuse to participate.
2.3 Motivation to participate
2.3a Personal benefit and cognitions
All patients joined the study hoping that the treatment would positively impact their arm function (recovery).
“It is the research that you can contribute to and if you are lucky and fall into the right group, then it may turn out to be positive. That is enough motivation for me to do something. Certainly because you know that the most progress can be expected in the first three months. And it now falls within those first three months. It seems to be highly recommendable to me." (P8)
This patient also expressed the hope to be in the intervention group, to be able to have a chance on recovery. Most patients had the belief that the brain can be influenced from outside, for example by using non-invasive brain stimulation. One patient could not make up his mind: "I do not know. Maybe. I do not actually know. I hope so, but I don't know for sure.” (P4) Different arguments were brought up why or how placebo might work.
A belief in the expertise of the researchers and the expectation that patients will not be harmed also contributed to volunteering in the study. Multiple patients felt that “If you start with something, you need to finish it” (P9) which ensured constant motivation during the trial.
Several patients expressed that participation was an offer too good to refuse. “If you get the chance to do something like this and you can help someone forward with it, I take that chance. It doesn't cost a dime! Take that chance." (P7) Linked to this, patients also felt motivated by the following beliefs: “It doesn’t hurt to try” and “Nothing ventured, nothing gained.” The concept of karma was also described by one of the patients: "You always get it [friendliness] in return if you act friendly." (P7)
Most patients described that their attitude towards rehabilitation and recovery is of importance for the outcome.
“I tried to stay reasonably positive. Because yes it was made clear, that the way you look at things, determines what your recovery will look like.” (P12)
"But if you immediately say no, then nothing happens either…" (P4)
A positive mindset and openness to experience seem ingredients for a fruitful recovery according to those patients.
Undergoing the treatment provided patients with an opportunity to be involved in scientific research, which they find fascinating. Their curiosity was fed.
2.3b Altruism
One of the most common reasons for participation in the trial was the hope to help current and future stroke patients. Several patients explicitly described their participation might benefit offspring or grandchildren.
“Well, I hope that I can offer my children and granddaughter a longer life through this. Maybe ... the benefit, that when having a stroke, or whatever you call it, that intervention is possible in a different way than what is now. Because I saw it as extra therapy and I have done science a service and I hope to my offspring too. I am happy that I have been able to contribute to the research; for my offspring and the rest of the people.” (P5)
This quote reflects the prevailing norms and values that are of importance to that person. Patients also demonstrated the willingness to participate to the advancement of science. Participation in the intervention provided patients with an opportunity to actively contribute to scientific research. One patient gave the example that participating would increase the diversity of age in the trial:
“... most people with whom I have been here are 60+. So, I thought maybe it is good, or interesting or nice for you …that also a younger person, I was 30 when it happened. That you can also see what it does to a young person. Perhaps there were very different results with me than with a fellow patient who is already in his seventies or sixties.” (P12)