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Current was delivered by electrodes encased in sponge pads 35 cm 2 soaked with 0. The machine was kept behind the participant and was out of the view of both the participant and the blind assessor for the entire stimulation period. For both the active and sham conditions, the anode was placed over the left motor cortex of the subject and the cathode was placed over the contralateral supraorbital region.

Electrodes were secured using soft elastic straps. The location of the motor cortex was estimated using the international 10—20 EEG system, with the centre of the electrode pad located 1 cm anterior and 4 cm lateral to the vertex. In the active stimulation condition, a constant current of 2 mA intensity current density 0. The researcher who applied the stimulation recorded the voltage levels 30 seconds after the onset of stimulation. For the primary analysis, the data from each session were analysed separately to answer the research question for parallel and crossover study designs.

This was in almost all cases noticed under the reference electrode. We recruited participants 75 female. The mean SD age was 24 8. Fifty-four participants were randomly allocated to receive active stimulation followed by sham. Ninety-nine participants completed the first stimulation session in full. One female participant withdrew from the study in the first session because they could not tolerate the stimulation. Three participants 2 female did not attend for a second session: two stated that they were too busy to participate further and one did not respond to correspondence. We obtained complete data from 96 participants.

Table 2 presents the frequency that the assessor noticed skin redness at the visible electrode site s under both stimulation conditions. The median voltage IQR at the start of stimulation was 9. We did this separately for each stimulation session.

A Living Textbook of Pragmatic Clinical Trials

There were no serious adverse events. When the first session was active stimulation, four participants reported an itch that was perceptible throughout the duration of stimulation. One of these participants reported a strong tingling that persisted for the first 2 minutes of stimulation. One participant reported a strong tingling sensation throughout the stimulation and one reported feeling dizzy and drowsy during the stimulation. In the second stimulation session, one participant reported mild dizziness during sham stimulation and one reported feeling drowsy during and immediately after active stimulation.


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The memory task was used primarily to distract participants from the true aim of the study. Given that the results have demonstrated that blinding of participants is imperfect it would be problematic to confidently attribute any observed effect on the memory task to the effects of stimulation, or indeed to the placebo effect.

As such we did not analyse this data further. Our results demonstrate that tDCS at 2 mA is not associated with effective blinding when compared with the commonly used sham using this electrode montage and stimulation procedure. Given the high agreement in the second session, the threat to participant blinding appears substantially worse for crossover trials.

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Participants were more confident in their judgement where they judged that they were receiving active stimulation after the first session though this difference diminished by the second stimulation session. It is highly likely that the sensory effects of active stimulation were responsible for compromising participant blinding. Familiarity with the experience of stimulation and the ability to compare between sessions amplified this issue after the second stimulation session.

Reports of persistent itch or tingling during stimulation in response to the adverse events question are suggestive of this. Most participants probably would not consider these sensations to be adverse effects and so only a minority reported them. The current finding has substantial implications for much of the existing literature relating to tDCS. For example, 2 mA intensity and similar electrode montages have been used in almost all trials of tDCS for chronic pain [11] , the majority of sham controlled tDCS trials for depression, [6] , [13] , [14] and all trials of tDCS for reducing cravings [16] , [18] — [20].

All of these studies have reported superior efficacy of active stimulation over sham and while some [13] , [14] report adequate participant blinding, the issue of assessor blinding was not assessed. While we cannot predict the degree of influence that inadequate blinding may have had in these studies, non-specific effects of interventions are known to be important in such clinical conditions [21] , [22].

Further, there is evidence that incomplete blinding leads to exaggerated effects in clinical studies with subjective outcomes [23] , and that placebo effects are larger with physical placebo interventions [22]. Thus, we contend that clinical studies that have used 2 mA tDCS should be interpreted with renewed caution. This point is emphasised by the recognised phenomenon that trials of new clinical interventions are often associated with small study effects and a publication bias that influence the evidence base, with a propensity for negative studies to not reach full publication [24] , [25].

How might blinding of tDCS at this intensity be improved? Assessor blinding might be ensured by having the participant wear headgear that conceals the area under the electrodes. It is possible that longer ramping times may improve participant blinding but this may not be sufficient where participants are aware of sensations throughout the stimulation period.

McFadden et al.

Rethinking Clinical Technique - Fred Busch - Google книги

Any modified sham protocol will require rigorous testing to ensure adequate blinding. An alternative approach may be to reduce stimulation intensity. Indeed, it is not clear that higher stimulation intensities are necessary in clinical studies [11].

Effects on cortical excitability have been clearly demonstrated at intensities of 1 mA [1] and there is evidence to suggest that successful participant blinding is achievable under these conditions [9] , [10]. Using intensities of 1 mA in future research may represent a more methodologically sound option, although it is plausible that reducing the intensity may reduce potential efficacy.

Future studies of tDCS may benefit from other methods to optimise blinding, for example de facto masking [27] , in which the treatment is not blinded but both treatments are presented as the active one. That we found inadequate blinding using a therapy widely held as blindable [8] raises the possibility that clinical trials of other therapies are vulnerable to similar problems. One obvious example is in trials of TENS, in which the sham condition often involves a deactivated TENS unit and as such there will be distinct differences in the experience of stimulation.

It is important to also acknowledge that inadequate blinding is not the only threat to the validity of clinical trials and continued attention should be paid in the design of trials to ensuring rigour in the selection and allocation process of future trials [28]. Our study has some limitations.

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We did not investigate the perceptual correlates of stimulation in any detail. We took this decision so as to minimise the risk that participants would over-scrutinize the experience of tDCS, which we felt would not accurately reflect the conditions of the average clinical trial. As such we cannot tell with confidence which factors most impacted on blinding.

The predominance of female participants might plausibly have affected our results. There is some evidence that differences exist between males and females, in pain threshold and pain evoked by a standard noxious stimulus, but the nature of the difference depends upon the type of stimulus and the context in which it is tested see [29] for a review. Popular Features. New Releases. Description With detailed clinical examples Busch show us when and how to intervene to help increase patient autonomy and self-reflective abilities.

The method presented can be integrated into clinical practice whatever the theoretical orientation or level of experience. Review quote In a respectful manner Dr. Busch questions many assumptions about psychoanalytic technique while continuing to elaborate his thinking on the significance of a contemporary ego psychology for clinical work no matter what the analyst's perspective. The book, written in his typically lucid style with many clinical examples, makes Dr.

Busch's thinking accessible even in the midst of complex issues.