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

March 14, 2023 updated by: Sascha Tafelski, Charite University, Berlin, Germany

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Pain Clinic of Charité hospital Campus Virchow Klinikum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control
sham transcranial direct current stimulation (tDCS)
Device: 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.
Experimental: cathodal stimulation
cathodal transcranial direct current stimulation (tDCS)
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.
Experimental: anodal stimulation
anodal transcranial direct current stimulation (tDCS)
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relative pain intensity
Time Frame: 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.
after completion of therapy series, typically after 2 weeks of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2016

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

April 15, 2016

First Submitted That Met QC Criteria

April 19, 2016

First Posted (Estimate)

April 22, 2016

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neuro-tDCS1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Clinical Study Report
    Information comments:

    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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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