The aim of this qualitative study was to gain insight into how rTMS treatment for upper limb recovery within stroke rehabilitation was experienced by patients who participated in the clinical trial. Overall, the patients reported positive experiences with the TMS treatment and believed that receiving rTMS had benefited their arm function. Aspects of the treatment that were experienced most favorably were the comfort of the treatment setting (e.g. moment of relaxation) and the absence of pain and side-effects. The main concerns were the fear of or uncertainty about negative consequences from the electrical currents within the brain and the annoyance of the pulses on the head. Most patients participated in the study to contribute to knowledge for treatment of future stroke patients and for personal benefit. Participation in a clinical trial was also experienced as a grateful experience and gave patients a sense of purpose.
Benefits and concerns related to rTMS treatment
Patients felt that the rTMS treatment was effective for the recovery of their affected arm, even though they were blinded from the treatment assignment –which could be sham stimulation– and outcome. Effectiveness was described by patients as being able to perform fine and gross movements with the affected arm (i.e. reduction of impairment and disability), being able to wash and dress themselves, and being able to participate in traffic as cyclist or car driver (i.e. activity and participation). These outcomes are contrary to the only (known) previous qualitative study in the field of non-invasive brain stimulation of Triccas et al. (2018) , where patients felt that receiving tDCS and robotic therapy was especially effective for their strength and tightness in the affected upper limb. This discrepancy in results could be explained by the design of the studies. Triccas et al. (2018)  used a robot, paired with tDCS, which trains hand grip rather than hand movements. The lack of ability to carry out two-handed tasks easier was one of the main concerns reported by their patients. The expressed hope and expectations of personal benefit for recovery are consistent with the main reasons for participation stated by patients in our trial. Assumptions of therapeutic benefit from participation in (stroke rehabilitation) research has also been found and discussed in other studies [21, 22].
The included patients evaluated receiving rTMS treatment positively. Positive experiences arose from the comfortable treatment settings, the interaction with the research-therapists, the way of information delivery, learning experiences, and the absence of pain or negative consequences. Comfort of the treatment was related to the way the treatment was built into their daily schedule, the low intensity of the treatment procedure, and the setting in which they received the brain stimulation. Patients were pleased that the treatments were scheduled and they experienced the treatments as a moment of relaxation during their full and sometimes tiring daily rehabilitation program. The short duration of the treatments may have ensured that the patients did not experience the intervention as a burden. However, in a qualitative descriptive study a high intensity programme was not viewed as a barrier to engagement for the included stroke patients. The acceptability and engagement with the high intensity programme was mediated by several factors, including making progress, internal and external motivators, and other group members . The treatment room in our study, which was experienced as quiet and low on stimuli, also contributed to the relaxed experience. The importance of comfort has also been emphasized by patients who evaluated novel stroke technologies .
The interaction with research staff administering the treatment was highly valued among the patients. Attributes of the researchers, i.e. being calm, competent, transparent and respectful, enabled a sense of safety and a strong therapeutic relationship. The friendly attitude of the research staff was highly valued and made patients look forward to their treatment session. These findings agree with results from a qualitative study  that reported that to be treated with respect and dignity was the core factor contributing to elderly stroke patients’ satisfaction with rehabilitation therapy. Subcategories as being treated with humanity, having confidence and trust in professionals, and dialogue and exchange of information were other determinants of satisfaction . In our study, the clarity of information and the step-by-step explanation of the different actions ensured that patients knew what to expect, and made them feel safe. The desire for information has previously been recognized as a key coping strategy and as a resource for psychosocial adjustment and empowerment [25, 26].
However, in addition to reported feelings of therapeutic benefit and positive experiences of undergoing rTMS treatment, some concerns were also identified. One of the main concerns were feelings of anxiety about the ‘electricity’ within the brain and uncertainty about possible negative consequences. This finding is consistent with findings from Triccas et al. (2018)  who reported that patients undergoing tDCS treatment had concerns about the ‘electricity’ applied via the electrodes, and were insecure about possible negative consequences. Some patients found the stimulation pulses annoying. The somatic scalp sensation due to TMS-induced activation of superficial nerves or muscles might feel different for each person  The reported annoyance of the TMS pulses, however, appear less severe compared to the reported itchy, painful, and burning sensations after tDCS .
Benefits and concerns related to participation in an RCT
The beneficial psychological impact of trial participation, beyond those of the treatment, has been increasingly recognized [28, 29]. Patients who perceived recovery during participation in our trial found this hopeful and motivating, which made them more likely to put effort in their rehabilitation. Our findings are consistent with data from studies that investigated stroke survivors’ perspective of upper limb recovery after stroke [30–35]. An individual’s experience of recovery helps to maintain their motivation [30, 31]. Furthermore, the hope for and belief in further recovery is related to an individual’s attempt to maximize upper limb recovery (i.e. ‘keeping doors open’) and overall stroke recovery [32, 34, 35].
Patients reported a powerful belief that they might receive an effective treatment, and acknowledged the possible effects on health and well-being. Expectancy, what a patient thinks or expects to happen as a result of the treatment, is one of the many contributing factors to the recognized placebo response . In addition to a placebo effect, being offered or ‘chosen’ to participate in a trial, resulting in a sense of hope, might contributed positively to emotional well-being. Trial participation as a privilege has also been reported by patients enrolled in a cancer-related clinical drug treatment trial . In our study, trial participation was also associated with the satisfaction of feeling useful and having a sense of purpose. Those feelings derived from being able to actively contribute to one’s recovery process, contributing to help for current and future stroke patients, and being part of scientific research resulting in more knowledge and therapeutic advancements. Curiosity and interest in scientific research were also mentioned as reasons to participate. By participating in the intervention, patients could learn more about the (working of the) brain and experience a novel rehabilitation technique. The societal benefits of participating in a trial and contributing to something greater than yourself, which may be consistent with existential well-being, has been reported for patients before [28, 38]. The concept of “intergenerational altruism” has been introduced to describe altruistic motivations to participate in research for the benefit of younger generations .
Some patients shared concerns about allocation to the control group, which could limit their chance of additional improvement. Several studies have explored the psychological burden for patients participating in an RCT, who were informed by the result of randomization, and acknowledged the discomfort of being randomized, and anxiousness or embarrassment to receive placebo [21, 40]. However, in our study the patients were unaware of group allocation. The concept of random allocation might be more difficult to accept for patients who know that they are receiving placebo, because they can compare themselves to the non-placebo group.
Our study has some limitations. First, the interviews were not conducted at a fixed time after the intervention period, causing some patients to have to recall memories from one to two years ago. Difficulties in recalling experiences could introduce a risk of cognitive bias. However, even in patients who were interviewed one to two years after participation in the trial, we noticed that they could reproduce their memories, suggesting that a period to process and reflect upon your experiences could also lead to a more matured memory. Second, the first author designed the protocol, recruited patients for the RCT, and analyzed the qualitative data, introducing the risk of bias. To minimize this risk, the author (LJ) who undertook the interviews and took no part in the RCT, also assisted in the data analysis. Third, although representative for many European hospitals, the rehabilitation setting in which our study was conducted may be different from other healthcare situations.
Clinical implications and directions for future research
Several treatment characteristics that could lead to effective implementation of rTMS in clinical care and implications of the findings for inpatient stroke rehabilitation and recommendations for future rTMS trials were identified from the interviews.
Implementation in clinical care
According to the experiences of the patients in an inpatient facility it is feasible to add rTMS therapy to a daily inpatient stroke rehabilitation program. Undergoing this treatment was not experienced as a burden. Careful communication seems to be a key factor in a patient’s sense of safety and satisfaction with rTMS treatment participation. Transparency, explanation of the procedures in layman’s terms, and a humane approach to the patient seem to be important factors. To anticipate to the patient’s concerns about electrical currents in the brain, negative consequences and painful sensations, personnel should pay attention to recurrently explaining the mode of action of rTMS, the non-invasive character of the treatment, and the limited possible risks. It is essential to pay close attention to the settings (i.e. equipment use, support materials, environment) in which the treatment is delivered to prevent discomfort. The active involvement of patient’s perspectives in the design of rTMS treatment delivery could be central in this.
Inpatient stroke rehabilitation
In the present study, we identified that patients value a moment of relaxation in between appointments of their rehabilitation program. These moments of rest could be built into the standard routine of inpatient stroke rehabilitation. According to the patients, the relaxation was felt because they could sit in a comfortable declined chair in a quiet room, and had the freedom to do nothing. The full procedure of preparation, installation and treatment delivery took a maximum of 10 minutes (the actual rTMS treatment lasted only 40 seconds), showing that this effect can be achieved in a relatively short period of time.
We also found that patient value feedback on their progress of motor recovery, as it contributes to an individual’s expectation, motivation, and attempts to maximize upper limb recovery. This could include communicating repeated measurements to the patient in advance and the use of patient reported outcome measures (PROMs). Repeating measurements over time and at specific time-points post-stroke (i.e. at least three months stroke, according to the SRRR ) is relevant for clinical care as research.
Future rTMS trials
Our results emphasize that participation in scientific research makes people feel useful and empowers them to contribute to something bigger than themselves. Future rTMS trials should consider describing the positive effects of participation in scientific research in their patient information letter. In addition, involved stakeholders (e.g. nursing staff, facility personnel) should also be aware of the positive effects that patients can experience in trial participation, especially when there are doubts about the feasibility of a study in rehabilitation care. The patient information letter should also clearly explain the working of the TMS and the possible side-effects.