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. 2022 Apr 18;4(1):14.
doi: 10.1186/s42466-022-00171-2.

A multicenter, randomized, double-blind, placebo-controlled trial to test efficacy and safety of transcranial direct current stimulation to the motor cortex after stroke (NETS): study protocol

NETS Trial Collaboration Group
Collaborators

A multicenter, randomized, double-blind, placebo-controlled trial to test efficacy and safety of transcranial direct current stimulation to the motor cortex after stroke (NETS): study protocol

NETS Trial Collaboration Group. Neurol Res Pract. .

Abstract

Introduction: The WHO estimates that each year 5 million people are left permanently disabled after stroke. Adjuvant treatments to promote the effects of rehabilitation are urgently needed. Cortical excitability and neuroplasticity can be enhanced by non-invasive brain stimulation but evidence from sufficiently powered, randomized controlled multi-center clinical trials is absent.

Methods: Neuroregeneration enhanced by transcranial direct current stimulation (tDCS) in stroke (NETS) tested efficacy and safety of anodal tDCS to the primary motor cortex of the lesioned hemisphere in the subacute phase (day 5-45) after cerebral ischemia. Stimulation was combined with standardized rehabilitative training and repeatedly applied in 10 sessions over a period of 2 weeks in a planned sample of 120 patients. Primary outcome parameter was upper-extremity function at the end of the 2-weeks intervention period of active treatment or placebo (1:1 randomization), measured by the upper-extremity Fugl-Meyer assessment. Sustainability of the treatment effect was evaluated by additional follow-up visits after 30 and 90 days. Further secondary endpoints included metrics of arm and hand function, stroke impact scale, and the depression module of the patient health questionnaire.

Perspective: NETS was aimed at providing evidence for an effective and safe adjuvant treatment for patients after stroke.

Trial registration: ClinicalTrials.gov Identifier NCT00909714. Registered May 28, 2009.

Keywords: Brain stimulation; Clinical trial; Neuroplasticity; Neurorehabilitation; Recovery; Stroke; Therapy.

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Conflict of interest statement

For a complete list of all potentially competing interests of all members of the writing committee and all investigators see Additional file 1.

Figures

Fig. 1
Fig. 1
Schematic of active tDCS (solid red line) and placebo stimulation (dashed black line). For both active and placebo stimulation, current was ramped up over 8 s to 1 mA (blue shaded areas). Active stimulation remained at this level for 1200 s (20 min) followed by fade-out over 8 s from 1 to 0 mA. Placebo stimulation remained stable at 1 mA for only 40 s before fade-out over 8 s
Fig. 2
Fig. 2
Assessment flow chart. In addition, at each time point a physical and neurological examination took place
See this image and copyright information in PMC

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