Studies using transcranial direct current stimulation (tDCS) typically compare an active protocol relative to a shorter sham (placebo) protocol. Both protocols are presumed to be perceptually identical on the scalp, and thus represent an effective method of delivering double‐blinded experimental designs. However, participants often show above‐chance accuracy when asked which condition involved active/sham retrospectively. We assessed the time course of sham‐blinding during active and sham tDCS. We predicted that participants would be aware that the current is switched on for longer in the active versus sham protocol. Thirty‐two adults were tested in a preregistered, double‐blinded, within‐subjects design. A forced‐choice reaction time task was undertaken before, during and after active (10 min 1 mA) and sham (20 s 1 mA) tDCS. The anode was placed over the left primary motor cortex (C3) to target the right hand, and the cathode on the right forehead. Two probe questions were asked every 30 s: “Is the stimulation on?” and “How sure are you?”. Distinct periods of non‐overlapping confidence intervals were identified between conditions, totalling 5 min (57.1% of the total difference in stimulation time). These began immediately after sham ramp‐down and lasted until the active protocol had ended. We therefore show a failure of placebo control during 1 mA tDCS. These results highlight the need to develop more effective methods of sham‐blinding during transcranial electrical stimulation protocols, even when delivered at low‐intensity current strengths.

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Background: Studies using transcranial direct current stimulation (tDCS) typically compare the effects of an active (10-30min) relative to a shorter sham (placebo) protocol. Both active and sham tDCS are presumed to be perceptually identical on the scalp, and thus represent an effective method of delivering double-blinded experimental designs. However, participants often show above-chance accuracy when asked which condition involved active/sham retrospectively.Objective/Hypothesis: We aimed to assess the time course of sham-blinding during active and sham tDCS. We predicted that 1) Participants will be aware that the current is switched on for a longer duration in the active versus the sham protocol, 2) Active anodal tDCS will reduce reaction times more effectively than sham.Methods: 32 adults were tested in a pre-registered, double-blinded, within-subjects design. A forced-choice reaction time task was undertaken before, during and after active (10min 1mA) andsham (20s 1mA) tDCS. The anode was placed over the left primary motor cortex (C3) to target the right hand, and the cathode on the right forehead. Two probe questions were asked every 30s: "Is the stimulation on? "and "How sure are you?".Results: Distinct periods of non-overlapping confidence intervals were identified between the active and sham conditions, totalling 5min (57.1% of the total difference in stimulation time). These began immediately after sham ramp-down and lasted until the active protocol had ended. Active tDCS had no effect on reaction times compared to sham (ΔRT active vs sham p>0.38 in all blocks). Conclusions:We show a failure of placebo control during low-intensity tDCS.

Abstract. Most people with dementia (PwD) are treated on an outpatient basis, predominantly by general practitioners (GPs). This article provides a detailed protocol of a study aimed at developing and evaluating a tablet-based intervention to improve outpatient dementia care by fostering guideline-based treatment. A cluster-randomized controlled trial with an intervention group (tablet-based intervention) and a control group (treatment as usual plus information handbook) will be conducted. Clusters will be randomized at GP level. Primary outcome is defined as adherence to dementia guideline recommendations after 9 months. Secondary outcomes include various health outcomes assessed in PwD (e.g., quality of life) and informal caregivers (e.g., caregiver burden). Outcomes will be analyzed by an intention-to-treat analysis and using mixed models.