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, Gemma Learmonth, Christopher S Y Benwell, Gesine Märker, Diana Dascalu, Matthew Checketts, Celestine Santosh, Mark Barber, Matthew Walters, Keith W Muir, Monika Harvey

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.

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

Conflict of interest statement

No potential conflict of interest was reported by the author(s).

Figures

Figure 1.
Figure 1.
Electrode montage and simulated current flow, performed with SimNIBS 3.1.0 (Thielscher et al., 2015). The 5 × 7 cm anode was positioned just anterior to the vertex (Cz) and the 5 × 5 cm cathode positioned over the left parietal cortex (P3). The normalized induced electric field (normE) is shown in V/m and the current induced by each electrode in mA.
Figure 2.
Figure 2.
Example of the Behavioural Training.
Figure 3.
Figure 3.
Number of confirmed (red line), estimated right hemisphere (green line), referred (purple line) and randomized strokes (blue line) presented cumulatively over the recruitment period.
Figure 4.
Figure 4.
Consort Flow Diagram. T1: time of baseline secondary outcome measure testing, T2: time of post-intervention testing, T3: time of follow-up testing. LNS: low neglect severity (BIT score of >115). HNS: high neglect severity (BIT score of

Figure 5.

Lesion maps for each of…

Figure 5.

Lesion maps for each of the 24 individuals, projected onto 13 axial slices…

Figure 5.
Lesion maps for each of the 24 individuals, projected onto 13 axial slices of the standardized older adult MNI template ((scct.nii) developed by Rorden et al., 2012), plus the cumulative overlap map. Orientation is per neuroscience standard with the right hemisphere on the right side in each slice.
Figure 5.
Figure 5.
Lesion maps for each of the 24 individuals, projected onto 13 axial slices of the standardized older adult MNI template ((scct.nii) developed by Rorden et al., 2012), plus the cumulative overlap map. Orientation is per neuroscience standard with the right hemisphere on the right side in each slice.

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