Neuralgia, Neuropathic Pain
Conditions
Keywords
neuropathic pain, neuralgia, tDCS, transcranial direct current stimulation
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.
Interventions
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.
DEVICEsham transcranial direct current stimulation (tDCS)
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.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| time to next regional-anesthesiological series | 6 months | time until patients need additional regional-anesthesiological interventions |
| number of regional-anesthesiological interventions for pain control | 10 days | number of required regional-anesthesiological interventions to achieve sufficient pain reduction |
| adverse events | 1 months | Analysis of adverse reaction (skin redness, headache, concentration, other) |
Countries
Germany
Outcome results
None listed