The Effects of Anodal tsDCS on Chronic Neuropathic Pain After SCI

NCT02863315 | Unknown

• 1 other identifier: 1604-007-752 SNUH
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the analgesic effect of transcutaneous spinal direct current stimulation (tsDCS) applied on spinal cord in patients with spinal cord injury who have chronic neuropathic pain.

Conditions

Neuropathic Pain; Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• Numeric rating scale (NRS) for neuropathic pain

  On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable

  Baseline NRS (average NRS over the preceding 24h), Change from Baseline NRS at 0, 60 and 120 minutes after the start of the stimulation

Secondary Outcomes (2)

• Patient Global Assessment (PGA)

  Baseline PGA (average PGA over the preceding 24h), Change from Baseline PGA at 0, 60 and 120 minutes after the start of the stimulation

• Present Pain Intensity (PPI)

  Baseline PPI (average PPI over the preceding 24h), Change from Baseline PPI at 0, 60 and 120 minutes after the start of the stimulation

Study Arms (2)

tsDCS

EXPERIMENTAL

In the tsDCS group, anodal tsDCS will be applied for 20 minutes.

Device: tsDCS

sham

PLACEBO COMPARATOR

In sham tsDCS group, the current of anodal tsDCS will be discontinued after 30 s while the power indicator remained on for 20 minutes.

Device: tsDCS

Interventions

tsDCS DEVICE

Both groups use the same DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany). In the tsDCS group, anode electrode is placed over tenth thoracic vertebra to target spinal cord with 2mA for 20 min, and the cathode (reference) electrode on the head vertex (in the Cz location according to the 10-20 EEG system) In sham tsDCS group, anode electrode is placed over tenth thoracic vertebra to target spinal cord with 2mA for 30s, and the cathode (reference) electrode on the head vertex (in the Cz location according to the 10-20 EEG system). The current was discontinued after 30 s while the power indicator remained on.

Also known as: DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany)

sham; tsDCS

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cervical or upper thoracic complete motor spinal cord injury, at least 6 months after SCI, 20\<=age\<90
• neuropathic pain (LANSS score \>= 12), stable chronic pain for at least the three preceding months but not over 5 years
• score higher than or equal to 4 cm (0 cm = 'no pain' and 10 cm = 'worst possible pain') on the visual ana- logue scale (VAS) for pain perception at the baseline/start of the treatment
• refractoriness to drugs for pain relief - such as tricyclic antidepressants, antiepileptic drugs, and/or narcot- ics (pain resistant to at least two of these drugs supplied in ade- quate dosages for 6 months)
• informed consent

You may not qualify if:

• patients with any clinically significant or unstable medical or progressive neurologic disorder
• contraindication for electrial stimulation such as pacemaker implant
• Women of childbearing age or pregnancy
• significant cognitive deficit
• Syringomyelia
• neuropsychiatric comorbidity
• depressive disorder (as indicated by a score of 10 greater on the Beck Depression Inventory)
• history of substance abuse
• skin defect under the electrodes
• progressive neurological disease or other secondary conditions that could impact neuropathic pain

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University

Seoul, 03080, South Korea

Location

Related Publications (4)

• Ngernyam N, Jensen MP, Arayawichanon P, Auvichayapat N, Tiamkao S, Janjarasjitt S, Punjaruk W, Amatachaya A, Aree-uea B, Auvichayapat P. The effects of transcranial direct current stimulation in patients with neuropathic pain from spinal cord injury. Clin Neurophysiol. 2015 Feb;126(2):382-90. doi: 10.1016/j.clinph.2014.05.034. Epub 2014 Jun 21.

  PMID: 25027640 BACKGROUND

• Cogiamanian F, Vergari M, Schiaffi E, Marceglia S, Ardolino G, Barbieri S, Priori A. Transcutaneous spinal cord direct current stimulation inhibits the lower limb nociceptive flexion reflex in human beings. Pain. 2011 Feb;152(2):370-375. doi: 10.1016/j.pain.2010.10.041. Epub 2010 Dec 14.

  PMID: 21159430 BACKGROUND

• Parazzini M, Fiocchi S, Liorni I, Rossi E, Cogiamanian F, Vergari M, Priori A, Ravazzani P. Modeling the current density generated by transcutaneous spinal direct current stimulation (tsDCS). Clin Neurophysiol. 2014 Nov;125(11):2260-2270. doi: 10.1016/j.clinph.2014.02.027. Epub 2014 Apr 3.

  PMID: 24784477 BACKGROUND

• Cogiamanian F, Vergari M, Pulecchi F, Marceglia S, Priori A. Effect of spinal transcutaneous direct current stimulation on somatosensory evoked potentials in humans. Clin Neurophysiol. 2008 Nov;119(11):2636-40. doi: 10.1016/j.clinph.2008.07.249. Epub 2008 Sep 10.

  PMID: 18786856 BACKGROUND

MeSH Terms

Conditions

Neuralgia; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: tsDCS
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: tsDCS

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 11, 2016
• Study Start: August 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: April 27, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)