Transcranial Direct Current Stimulation (tDCS) in Chronic Neuropathy

NCT ID: NCT02747758

Last Updated: 2023-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-19

Study Completion Date

2021-01-31

Brief Summary

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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

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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

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Neuropathic Pain Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

sham transcranial direct current stimulation (tDCS)

Group Type SHAM_COMPARATOR

sham transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

transcranial direct current stimulation (tDCS) is applied in active groups using a sham-stimulation including ramp up and ramp down of current.

cathodal stimulation

cathodal transcranial direct current stimulation (tDCS)

Group Type EXPERIMENTAL

cathodal transcranial direct current stimulation (tDCS)

Intervention Type 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.

anodal stimulation

anodal transcranial direct current stimulation (tDCS)

Group Type EXPERIMENTAL

anodal transcranial direct current stimulation (tDCS)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Sascha Tafelski

physician scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Schäfer, Prof. MD

Role: STUDY_CHAIR

Charité University Berlin

Locations

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Pain Clinic of Charité hospital Campus Virchow Klinikum

Berlin, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 25479710 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17053811 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23321703 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20471549 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26469395 (View on PubMed)

Study Documents

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Document Type: Clinical Study Report

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

View Document

Related Links

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Other Identifiers

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Neuro-tDCS1

Identifier Type: -

Identifier Source: org_study_id

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