Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2021 Sep;31(8):1163-1189.
doi: 10.1080/09602011.2020.1767161. Epub 2020 Jun 5.

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  1   2 , Christopher S Y Benwell  2   3 , Gesine Märker  2 , Diana Dascalu  2 , Matthew Checketts  2   4 , Celestine Santosh  5 , Mark Barber  6 , Matthew Walters  7 , Keith W Muir  1 , Monika Harvey  2
Affiliations
Randomized Controlled Trial

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 et al. Neuropsychol Rehabil. 2021 Sep.

Erratum in

  • Correction.
    [No authors listed] [No authors listed] Neuropsychol Rehabil. 2022 Jun;32(5):794-795. doi: 10.1080/09602011.2022.2092326. Neuropsychol Rehabil. 2022. PMID: 35854657 Free PMC article. No abstract available.

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).

PubMed Disclaimer

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 <115).
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.
See this image and copyright information in PMC

References

    1. Allman, C., Amadi, U., Winkler, A. M., Wilkins, L., Filippini, N., Kischka, U., Stagg, C., & Johansen-Berg, H. (2016). Ipsilesional anodal tDCS enhances the functional benefits of rehabilitation in patients after stroke. Science Translational Medicine, 8(330), 330re1–330re1. 10.1126/scitranslmed.aad5651 - DOI - PMC - PubMed
    1. Antal, A., Kincses, T. Z., Nitsche, M. A., Bartfai, O., & Paulus, W. (2004). Excitability changes induced in the human primary visual cortex by transcranial direct current stimulation: Direct electrophysiological evidence. Investigative Ophthalmology & Visual Science, 45(2), 702–707. 10.1167/iovs.03-0688 - DOI - PubMed
    1. Bang, D.-H., & Bong, S.-Y. (2015). Effect of combination of transcranial direct current stimulation and feedback training on visuospatial neglect in patients with sub-acute stroke: A pilot randomized controlled trial. Journal of Physical Therapy Science, 27(9), 2759–2761. 10.1589/jpts.27.2759 - DOI - PMC - PubMed
    1. Beck, A. T., Steer, R. A., & Brown, G. K. (1996). Beck depression inventory-second edition manual. The Psychological Corporation.
    1. Benwell, C. S. Y., Learmonth, G., Miniussi, C., Harvey, M., & Thut, G. (2015). Non-linear effects of transcranial direct current stimulation as a function of individual baseline performance: Evidence from biparietal tDCS influence on lateralized attention bias. Cortex, 69, 152–165. 10.1016/j.cortex.2015.05.007 - DOI - PubMed

Publication types

Associated data