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. The validation of treatment efficacy requires sham-controlled experiments but increased current densities might comprise blinding. Therefore, we conducted a pilot study 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 cross-over design (active/sham stimulation, randomized order) in 12 early subacute patients with left-sided hemineglect. Stimulation was performed simultaneous to standard care neglect therapy with 0.8 A/m². Progress of neglect symptomatology was also monitored during inpatient rehabilitation.
Results Higher odds of correct guessing an active tDCS condition compared to wrongly judge an active tDCS condition as sham stimulation (Odds ratio 10.00, 95%CI: 0.65 - 154.40, p = 0.099) were observed. Therefore, blinding success remains debatable in neglect studies with current densities of 0.8 A/m² and still warrants further investigation.
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On 22 May, 2020
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On 05 May, 2020
On 27 Apr, 2020
On 27 Apr, 2020
On 13 Dec, 2020
On 09 Dec, 2020
On 17 Nov, 2020
Received 15 Nov, 2020
On 03 Oct, 2020
Received 26 Sep, 2020
Invitations sent on 16 Sep, 2020
On 16 Sep, 2020
On 11 Sep, 2020
On 10 Sep, 2020
On 10 Sep, 2020
Posted 30 Jul, 2020
On 25 Aug, 2020
Received 14 Aug, 2020
On 02 Aug, 2020
Invitations sent on 28 Jul, 2020
On 25 Jul, 2020
On 24 Jul, 2020
On 24 Jul, 2020
On 12 Jun, 2020
Received 26 May, 2020
On 22 May, 2020
On 12 May, 2020
Invitations sent on 11 May, 2020
On 05 May, 2020
On 27 Apr, 2020
On 27 Apr, 2020
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. The validation of treatment efficacy requires sham-controlled experiments but increased current densities might comprise blinding. Therefore, we conducted a pilot study 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 cross-over design (active/sham stimulation, randomized order) in 12 early subacute patients with left-sided hemineglect. Stimulation was performed simultaneous to standard care neglect therapy with 0.8 A/m². Progress of neglect symptomatology was also monitored during inpatient rehabilitation.
Results Higher odds of correct guessing an active tDCS condition compared to wrongly judge an active tDCS condition as sham stimulation (Odds ratio 10.00, 95%CI: 0.65 - 154.40, p = 0.099) were observed. Therefore, blinding success remains debatable in neglect studies with current densities of 0.8 A/m² and still warrants further investigation.
This is a list of supplementary files associated with this preprint. Click to download.
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