Transcranial Direct Current Stimulation (tDCS) in Chronic Neuropathy (Neuro-tDCS)
Primary Purpose
Neuropathic Pain, Neuralgia
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
cathodal transcranial direct current stimulation (tDCS)
sham transcranial direct current stimulation (tDCS)
anodal transcranial direct current stimulation (tDCS)
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain focused on measuring neuropathic pain, neuralgia, tDCS, transcranial direct current stimulation
Eligibility Criteria
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
Sites / Locations
- Pain Clinic of Charité hospital Campus Virchow Klinikum
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Experimental
Experimental
Arm Label
Control
cathodal stimulation
anodal stimulation
Arm Description
sham transcranial direct current stimulation (tDCS)
cathodal transcranial direct current stimulation (tDCS)
anodal transcranial direct current stimulation (tDCS)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
time to next regional-anesthesiological series
time until patients need additional regional-anesthesiological interventions
number of regional-anesthesiological interventions for pain control
number of required regional-anesthesiological interventions to achieve sufficient pain reduction
adverse events
Analysis of adverse reaction (skin redness, headache, concentration, other)
Full Information
NCT ID
NCT02747758
First Posted
April 15, 2016
Last Updated
March 14, 2023
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT02747758
Brief Title
Transcranial Direct Current Stimulation (tDCS) in Chronic Neuropathy
Acronym
Neuro-tDCS
Official Title
Randomized Controlled Clinical Trial Evaluating Transcranial Direct Current Stimulation (tDCS) in Chronic Pain Patients With Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Recruitment due to CORONA
Study Start Date
September 19, 2016 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
January 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Neuralgia
Keywords
neuropathic pain, neuralgia, tDCS, transcranial direct current stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
sham transcranial direct current stimulation (tDCS)
Arm Title
cathodal stimulation
Arm Type
Experimental
Arm Description
cathodal transcranial direct current stimulation (tDCS)
Arm Title
anodal stimulation
Arm Type
Experimental
Arm Description
anodal transcranial direct current stimulation (tDCS)
Intervention Type
Device
Intervention Name(s)
cathodal transcranial direct current stimulation (tDCS)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham transcranial direct current stimulation (tDCS)
Intervention Description
transcranial direct current stimulation (tDCS) is applied in active groups using a sham-stimulation including ramp up and ramp down of current.
Intervention Type
Device
Intervention Name(s)
anodal transcranial direct current stimulation (tDCS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
relative pain intensity
Description
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.
Time Frame
after completion of therapy series, typically after 2 weeks of treatment
Secondary Outcome Measure Information:
Title
acute pain reduction by tDCS application (relative reduciton measured as VAS after completion of tDCS stimulation versus initial VAS measured before stimulation)
Description
relative reduction of pain intensity before and after each tDCS session and infiltration
Time Frame
30 Minutes after application
Title
time to next regional-anesthesiological series
Description
time until patients need additional regional-anesthesiological interventions
Time Frame
6 months
Title
number of regional-anesthesiological interventions for pain control
Description
number of required regional-anesthesiological interventions to achieve sufficient pain reduction
Time Frame
10 days
Title
adverse events
Description
Analysis of adverse reaction (skin redness, headache, concentration, other)
Time Frame
1 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Schäfer, Prof. MD
Organizational Affiliation
Charité University Berlin
Official's Role
Study Chair
Facility Information:
Facility Name
Pain Clinic of Charité hospital Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25479710
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.
Results Reference
background
PubMed Identifier
17053811
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.
Results Reference
background
PubMed Identifier
23321703
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.
Results Reference
background
PubMed Identifier
20471549
Citation
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.
Results Reference
background
PubMed Identifier
26469395
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.
Results Reference
background
Links:
URL
https://anaesthesieintensivmedizin.charite.de/leistungen/schmerztherapie/
Description
Pain Clinic Website
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.frontiersin.org/articles/10.3389/fneur.2023.1069434/full
Available IPD/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
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Transcranial Direct Current Stimulation (tDCS) in Chronic Neuropathy
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