Blinding in electric current stimulation in subacute neglect patients with current densities of 0.8 A/m2: a cross-over pilot study

BMC Res Notes. 2021 Jan 25;14(1):35. doi: 10.1186/s13104-020-05421-7.

Abstract

Objective: Neglect after stroke is a disabling disorder and its rehabilitation is a major challenge. Transcranial direct current stimulation (tDCS) seems to be a promising adjuvant technique to improve standard care neglect therapy. Since electric fields are influenced by age-related factors, higher current densities are probably needed for effective treatment in aged stroke patients. Validation of treatment efficacy requires sham-controlled experiments, but increased current densities might comprise blinding. Therefore, a pilot study was conducted to test sham adequacy when using current density of 0.8 A/m2. Whether especially neglect patients who mainly suffer from perceptual and attentional deficits are able to differentiate beyond chance active from sham tDCS was investigated in a randomized cross-over design (active/sham stimulation) in 12 early subacute patients with left-sided hemineglect. Stimulation (0.8 A/m2) was performed simultaneous to standard care neglect therapy.

Results: Odds ratio of correct guessing an atDCS condition compared to wrongly judge an atDCS condition as sham was 10.00 (95%CI 0.65-154.40, p = 0.099). However, given the small sample size and high OR, although likely somewhat overestimated, results require careful interpretation and blinding success in neglect studies with current densities of 0.8 A/m2 should be further confirmed.

Keywords: Blinding procedure; Pilot study; Stroke; Transcranial direct current stimulation; Visuospatial neglect.

MeSH terms

  • Aged
  • Cross-Over Studies
  • Double-Blind Method
  • Humans
  • Pilot Projects
  • Stroke Rehabilitation*
  • Stroke* / complications
  • Stroke* / therapy
  • Transcranial Direct Current Stimulation*