Transcranial Direct Current Stimulation (tDCS) in Chronic Neuropathy
- Conditions
- Neuropathic PainNeuralgia
- Interventions
- Device: sham transcranial direct current stimulation (tDCS)Device: anodal transcranial direct current stimulation (tDCS)Device: cathodal transcranial direct current stimulation (tDCS)
- Registration Number
- NCT02747758
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 17
- Patients with neuropathic pain with indication of regional anaesthesiological interventions
- <18 years of age
- Pregnancy
- Police custody
- Epilepsy
- Participation in another prospective clinical intervention study within the last 30 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control sham transcranial direct current stimulation (tDCS) sham transcranial direct current stimulation (tDCS) anodal stimulation anodal transcranial direct current stimulation (tDCS) anodal transcranial direct current stimulation (tDCS) cathodal stimulation cathodal transcranial direct current stimulation (tDCS) cathodal transcranial direct current stimulation (tDCS)
- Primary Outcome Measures
Name Time Method relative pain intensity after completion of therapy series, typically after 2 weeks of treatment 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.
- Secondary Outcome Measures
Name Time Method time to next regional-anesthesiological series 6 months time until patients need additional regional-anesthesiological interventions
adverse events 1 months Analysis of adverse reaction (skin redness, headache, concentration, other)
acute pain reduction by tDCS application (relative reduciton measured as VAS after completion of tDCS stimulation versus initial VAS measured before stimulation) 30 Minutes after application relative reduction of pain intensity before and after each tDCS session and infiltration
number of regional-anesthesiological interventions for pain control 10 days number of required regional-anesthesiological interventions to achieve sufficient pain reduction
Trial Locations
- Locations (1)
Pain Clinic of Charité hospital Campus Virchow Klinikum
🇩🇪Berlin, Germany