Non-invasive brain stimulation in Stroke patients (NIBS): A prospective randomized open blinded end-point (PROBE) feasibility trial using transcranial direct current stimulation (tDCS) in post-stroke hemispatial neglect

Gemma Learmonth, Christopher S. Y. Benwell, Gesine Märker, Diana Dascalu, Matthew Checketts, Celestine Santosh, Mark Barber, Matthew Walters, Keith W. Muir, Monika Harvey (Lead / Corresponding author)

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Abstract

Up to 80% of people who experience a right-hemisphere stroke suffer from hemispatial neglect. This syndrome is debilitating and impedes rehabilitation. We carried out a clinical feasibility trial of transcranial direct current stimulation (tDCS) and a behavioural rehabilitation programme, alone or in combination, in patients with neglect. Patients >4 weeks post right hemisphere stroke were randomized to 10 sessions of tDCS, 10 sessions of a behavioural intervention, combined intervention, or a control task. Primary outcomes were recruitment and retention rates, with secondary outcomes effect sizes on measures of neglect and quality of life, assessed directly after the interventions, and at 6 months follow up. Of 288 confirmed stroke cases referred (representing 7% of confirmed strokes), we randomized 8% (0.6% of stroke cases overall). The largest number of exclusions (91/288 (34%)) were due to medical comorbidities that prevented patients from undergoing 10 intervention sessions. We recruited 24 patients over 29 months, with 87% completing immediate post-intervention and 67% 6 month evaluations. We established poor feasibility of a clinical trial requiring repeated hospital-based tDCS within a UK hospital healthcare setting, either with or without behavioural training, over a sustained time period. Future trials should consider intensity, duration and location of tDCS neglect interventions.Trial registration: ClinicalTrials.gov identifier: NCT02401724.

Original languageEnglish
Number of pages27
JournalNeuropsychological Rehabilitation
Early online date5 Jun 2020
DOIs
Publication statusE-pub ahead of print - 5 Jun 2020

Keywords

  • Hemispatial neglect
  • Non-invasive brain stimulation
  • Prospective randomized open blinded end-point (PROBE) trial
  • Stroke
  • Transcranial direct current stimulation (tDCS)

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