Evaluation of a home-based transcranial direct current stimulation (tDCS) treatment device for chronic pain: study protocol for a randomised controlled trial

Springer Science and Business Media LLC - Tập 16 - Trang 1-6 - 2015
Francis O’Neill1,2, Paul Sacco1, Turo Nurmikko1
1Pain Research Institute, Clinical Sciences Centre, Lower Lane, Fazackerley, Liverpool, UK
2Department of Oral Surgery, Liverpool University Dental Hospital, Liverpool, UK

Tóm tắt

Stimulation of the primary motor cortex (M1) has been shown to reduce the pain of neuropathy in multiple studies. There are several methods of stimulation both invasive and non-invasive. Recent work by this laboratory has seen that 40% of a sample of chronic neuropathic pain patients responded positively to non-invasive repetitive transcranial magnetic stimulation (rTMS) to the motor cortex with a reduction in pain levels by at least 20%. The effect however is short lived and multiple return visits are necessary to maintain this response. Transcranial direct current stimulation (tDCS) offers a more mobile method of motor cortex stimulation and is similarly non-invasive. The protocol described is designed to assess the analgesic effect of a home-based tDCS treatment device on chronic neuropathic pain in both responders and non-responders to previous TMS treatment. This article reports the protocol for a randomised, sham-controlled, double-blinded crossover study in which patients with chronic neuropathic pain (n = 24) will receive anodal, cathodal and sham tDCS over M1. All patients will have previously completed a study of rTMS of the motor cortex and have been designated as responders or non-responders to this modality. Patients receive all three tDCS stimulation types by self-administration. We assess the effect on pain scores [numerical rating scale (NRS)], self reported health status (Short Form-36 Health Survey) and anxiety/depression (Hospital Anxiety and Depression Scale). A linear mixed model with fixed effects will analyse changes in pain scores from pre- to post- interventions. Analysis will be carried out on an intention-to-treat basis. A proportion analysis will also be carried out with patients separated into either responders or non-responders to previous TMS. Safety will be assessed throughout the study by monitoring of adverse events. The result of this trial will assess the efficacy of self-administered tDCS of the motor cortex in the treatment of chronic neuropathic pain and also provide insight into whether a potential differential effect is seen in patients that have previously been shown to be either responsive or non-responsive to rTMS over the same area. ISRCTN56839387 date 27 January 2014. First patient randomised to trial 30 October 2012.

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