Transcranial Direct Current Stimulation (tDCS) in Chronic Neuropathy (Neuro-tDCS)

Randomized Controlled Clinical Trial Evaluating Transcranial Direct Current Stimulation (tDCS) in Chronic Pain Patients With Neuropathy

This study evaluates the effect of additional transcranial direct stimulation (tDCS) on pain in patients with chronic neuropathic pain undergoing treatment with regional anaesthesiological techniques.

About 3.8 Million persons in Germany suffer from chronic pain with a relevant physical and social impairment representing approximately 7% of the population. Chronic pain conditions include patients with neuropathic pain such as trigeminal neuralgia, post-zoster pain or pain after amputations. There is a significant number of patients with pain without response to optimised drug therapy. Especially in these chronic pain patients there is data demonstrating maladaptive plasticity as pathophysiological evidence of structural changes in brain connectivity. Patients are treated with multimodal pain therapy concepts including interventional procedures with nerve infiltration techniques. One innovative therapeutic option for pain patients is transcranial direct current stimulation (tDCS): In recent clinical trials, patients reported on reduced overall pain intensity following tDCS stimulation series shown e.g. from Bolognini et al., Antal et al. and most recently from Volz and colleagues. However, there is no current data available evaluating a role of tDCS for patients with chronic neuropathic pain treated with regional anaesthesiological techniques. Objective: To evaluate effect of additional tDCS series on pain in patients with chronic neuropathic pain Primary study endpoint: relative reduction in pain (initial VAS measured versus VAS after completion of the therapy series) as a numeric value between 0 and 10.

transcranial direct current stimulation (tDCS) is applied in active groups using cathodal active M1 stimulation. Active stimulation is applied with 2mA direct current via 20cm² electrodes.

transcranial direct current stimulation (tDCS) is applied in active groups using a sham-stimulation including ramp up and ramp down of current.

transcranial direct current stimulation (tDCS) is applied in active groups using anodal active M1 stimulation. Active stimulation is applied with 2mA direct current via 20cm² electrodes.

relative reduction in pain intensity (initial VAS measured versus VAS after completion of the therapy series), VAS as a numeric value between 0 and 10.

acute pain reduction by tDCS application (relative reduciton measured as VAS after completion of tDCS stimulation versus initial VAS measured before stimulation)

Inclusion Criteria: Patients with neuropathic pain with indication of regional anaesthesiological interventions Exclusion Criteria: <18 years of age Pregnancy Police custody Epilepsy Participation in another prospective clinical intervention study within the last 30 days

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Antal A, Terney D, Kuhnl S, Paulus W. Anodal transcranial direct current stimulation of the motor cortex ameliorates chronic pain and reduces short intracortical inhibition. J Pain Symptom Manage. 2010 May;39(5):890-903. doi: 10.1016/j.jpainsymman.2009.09.023.

Volz MS, Farmer A, Siegmund B. Reduction of chronic abdominal pain in patients with inflammatory bowel disease through transcranial direct current stimulation: a randomized controlled trial. Pain. 2016 Feb;157(2):429-437. doi: 10.1097/j.pain.0000000000000386.

The research report is published open access: ORIGINAL RESEARCH article Front. Neurol., 01 March 2023, Volume 14 - 2023 | https://doi.org/10.3389/fneur.2023.1069434