Transcranial Direct Current Stimulation (tDCS) in Chronic Neuropathy

Neuropathic Pain Clinical Trial

— Neuro-tDCS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02747758
• Other study ID #: Neuro-tDCS1
• Status: Terminated
• Phase: N/A
• Start date: September 19, 2016
• Est. completion date: January 2021

Study information

• Verified date: March 2023
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: January 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Device:
• cathodal transcranial direct current stimulation (tDCS)
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.
• sham 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.
• anodal transcranial direct current stimulation (tDCS)
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.

Locations

Country	Name	City	State
Germany	Pain Clinic of Charité hospital Campus Virchow Klinikum	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. — View Citation

Flor H, Nikolajsen L, Staehelin Jensen T. Phantom limb pain: a case of maladaptive CNS plasticity? Nat Rev Neurosci. 2006 Nov;7(11):873-81. doi: 10.1038/nrn1991. — View Citation

Hauser W, Schmutzer G, Hinz A, Hilbert A, Brahler E. [Prevalence of chronic pain in Germany. A representative survey of the general population]. Schmerz. 2013 Feb;27(1):46-55. doi: 10.1007/s00482-012-1280-z. German. — View Citation

Tafelski S, Beutlhauser T, Gouliou-Mayerhauser E, Fritzsche T, Denke C, Schafer M. [Practice of regional anesthesia for chronic pain patients in specialized pain services : A nationwide survey in Germany]. Schmerz. 2015 Apr;29(2):186-94. doi: 10.1007/s00482-014-1503-6. German. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relative pain intensity	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.	after completion of therapy series, typically after 2 weeks of treatment
Secondary	acute pain reduction by tDCS application (relative reduciton measured as VAS after completion of tDCS stimulation versus initial VAS measured before stimulation)	relative reduction of pain intensity before and after each tDCS session and infiltration	30 Minutes after application
Secondary	time to next regional-anesthesiological series	time until patients need additional regional-anesthesiological interventions	6 months
Secondary	number of regional-anesthesiological interventions for pain control	number of required regional-anesthesiological interventions to achieve sufficient pain reduction	10 days
Secondary	adverse events	Analysis of adverse reaction (skin redness, headache, concentration, other)	1 months

External Links

•   Pain Clinic Website