Neuropathic PainNeuro-tDCSNCT02747758
Transcranial Direct Current Stimulation (tDCS) in Chronic Neuropathy
A study testing cathodal transcranial direct current stimulation (tDCS) and anodal transcranial direct current stimulation (tDCS) in people with Neuropathic Pain and Neuralgia, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Neuralgia
- What is being tested?
- cathodal transcranial direct current stimulation (tDCS) and anodal transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteGermany
- Study dates
- 19 Sep 2016to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with neuropathic pain with indication of regional anaesthesiological interventions
Who cannot join
- <18 years of age
- Pregnancy
- Police custody
- Epilepsy
- Participation in another prospective clinical intervention study within the last 30 days
Trial locations and contacts
1 site in 1 country.
Germany1 site
Pain Clinic of Charité hospital Campus Virchow Klinikum
Berlin, 13353
About this study
Official title: 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.
Read the 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.
- Conditions
- Neuropathic Pain, Neuralgia
- Being tested
- cathodal transcranial direct current stimulation (tDCS), sham transcranial direct current stimulation (tDCS), anodal transcranial direct current stimulation (tDCS)
- Keywords
- neuropathic pain, neuralgia, tDCS, transcranial direct current stimulation
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cathodal transcranial direct current stimulation (tDCS)Device
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)Device
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)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | sham transcranial direct current stimulation (tDCS) Receives: Device: sham transcranial direct current stimulation (tDCS) |
| cathodal stimulation | Experimental | cathodal transcranial direct current stimulation (tDCS) Receives: Device: cathodal transcranial direct current stimulation (tDCS) |
| anodal stimulation | Experimental | anodal transcranial direct current stimulation (tDCS) Receives: Device: anodal transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after completion of therapy series, typically after 2 weeks of treatment
Secondary outcomes (4)
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
Measured: 30 Minutes after application
time to next regional-anesthesiological series
time until patients need additional regional-anesthesiological interventions
Measured: 6 months
number of regional-anesthesiological interventions for pain control
number of required regional-anesthesiological interventions to achieve sufficient pain reduction
Measured: 10 days
adverse events
Analysis of adverse reaction (skin redness, headache, concentration, other)
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study start19 Sep 2016
- Primary completionDec 2020
- Study completionJan 2021
Why it stopped: Recruitment due to CORONA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sascha Tafelski, Charite University, Berlin, Germany
- Investigators
- Michael Schäfer, Prof. MD, Study chair, Charité University Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747758
- Sponsor's protocol ID
- Neuro-tDCS1
- Acronym
- Neuro-tDCS
- Status last verified
- Mar 2023
- First submitted
- 15 Apr 2016
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 25479710Flor 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.
PubMed 17053811Hauser 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.
PubMed 23321703Antal 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.
PubMed 20471549Volz 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.
PubMed 26469395
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial Evaluating Transcranial Direct Current Stimulation (tDCS) in Chronic Pain Patients With Neuropathy
- ClinicalTrials.gov ID
- NCT02747758
- Acronym / sponsor ID
- Neuro-tDCS / Neuro-tDCS1
- Conditions
- Neuropathic Pain, Neuralgia
- Keywords
- neuropathic pain, neuralgia, tDCS, transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment due to CORONA
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 19 Sep 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Device: sham transcranial direct current stimulation (tDCS)sham transcranial direct current stimulation (tDCS) |
| cathodal stimulation | Experimental | Device: cathodal transcranial direct current stimulation (tDCS)cathodal transcranial direct current stimulation (tDCS) |
| anodal stimulation | Experimental | Device: anodal transcranial direct current stimulation (tDCS)anodal transcranial direct current stimulation (tDCS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with neuropathic pain with indication of regional anaesthesiological interventions
Key exclusion criteria (5 listed)
- <18 years of age
- Pregnancy
- Police custody
- Epilepsy
- Participation in another prospective clinical intervention study within the last 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | cathodal stimulation |
| 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. | Device | Control |
| 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. | Device | anodal stimulation |
Primary outcome
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.
4 secondary outcomes
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
time to next regional-anesthesiological series
Time frame: 6 months
number of regional-anesthesiological interventions for pain control
Time frame: 10 days
adverse events
Time frame: 1 months
Results and safety
The study was stopped early (reason given: Recruitment due to CORONA). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Background: PubMed 25479710Tafelski 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.
- Background: PubMed 17053811Flor 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.
- Background: PubMed 23321703Hauser 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.
- Background: PubMed 20471549Antal 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.
- Background: PubMed 26469395Volz 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.
- Pain Clinic WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Schäfer, Prof. MD study chair
Charité University Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cathodal transcranial direct current stimulation (tDCS) and anodal transcranial direct current stimulation (tDCS) in people with Neuropathic Pain and Neuralgia, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment due to CORONA). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relative pain intensity (time frame: after completion of therapy series, typically after 2 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02747758, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023; AzTrials last refreshed its copy on 3 Nov 2026.