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

Charité University Medicine Berlin

Status: Terminated

Conditions: Neuropathic Pain; Neuralgia

Treatments: Device: sham transcranial direct current stimulation (tDCS); Device: anodal transcranial direct current stimulation (tDCS); Device: cathodal transcranial direct current stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02747758

Neuro-tDCS1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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17 participants in 3 patient groups

Control

Sham Comparator group

Description:

sham transcranial direct current stimulation (tDCS)

Treatment:

Device: sham transcranial direct current stimulation (tDCS)

cathodal stimulation

Experimental group

Description:

cathodal transcranial direct current stimulation (tDCS)

Treatment:

Device: cathodal transcranial direct current stimulation (tDCS)

anodal stimulation

Experimental group

Description:

anodal transcranial direct current stimulation (tDCS)

Treatment:

Device: anodal transcranial direct current stimulation (tDCS)