Transcranial Direct Current Stimulation (tDCS) in Chronic Neuropathy

NCT02747758 | Terminated DMC

• 1 other identifier: Neuro-tDCS1
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain; Neuralgia

Keywords

neuropathic pain; neuralgia; tDCS; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• acute pain reduction by tDCS application (relative reduciton measured as VAS after completion of tDCS stimulation versus initial VAS measured before stimulation)

  30 Minutes after application

• time to next regional-anesthesiological series

  6 months

• number of regional-anesthesiological interventions for pain control

  10 days

• adverse events

  1 months

Study Arms (3)

Control

SHAM COMPARATOR

sham transcranial direct current stimulation (tDCS)

Device: sham transcranial direct current stimulation (tDCS)

cathodal stimulation

EXPERIMENTAL

cathodal transcranial direct current stimulation (tDCS)

Device: cathodal transcranial direct current stimulation (tDCS)

anodal stimulation

EXPERIMENTAL

anodal transcranial direct current stimulation (tDCS)

Device: anodal transcranial direct current stimulation (tDCS)

Interventions

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.

cathodal stimulation

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.

Control

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.

anodal stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with neuropathic pain with indication of regional anaesthesiological interventions

You may not qualify if:

• \<18 years of age
• Pregnancy
• Police custody
• Epilepsy
• Participation in another prospective clinical intervention study within the last 30 days

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Pain Clinic of Charité hospital Campus Virchow Klinikum

Berlin, 13353, Germany

Location

Related Publications (5)

• 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.

  PMID: 25479710 BACKGROUND

• 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.

  PMID: 17053811 BACKGROUND

• 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.

  PMID: 23321703 BACKGROUND

• 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.

  PMID: 20471549 BACKGROUND

• 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.

  PMID: 26469395 BACKGROUND

Related Links

• Pain Clinic Website

MeSH Terms

Conditions

Neuralgia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Michael Schäfer, Prof. MD

  Charité University Berlin

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physician scientist

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: April 22, 2016
• Study Start: September 19, 2016
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2021
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)