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The Effects of Anodal tsDCS on Chronic Neuropathic Pain After SCI

Primary Purpose

Neuropathic Pain, Spinal Cord Injury

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
tsDCS
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. cervical or upper thoracic complete motor spinal cord injury, at least 6 months after SCI, 20<=age<90
  2. neuropathic pain (LANSS score >= 12), stable chronic pain for at least the three preceding months but not over 5 years
  3. 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
  4. 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)
  5. informed consent

Exclusion Criteria:

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

Sites / Locations

  • Seoul National University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tsDCS

sham

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient Global Assessment (PGA)
One of the most widely used patient reported outcomes (PROs) & PGA reflects the global impact of the disease from the patient's perspective Markedly improved Moderately improved Mildly improved No change Mildly worse Moderately worse Markedly worse
Present Pain Intensity (PPI)
Patient's subjective feeling of the intensity of pain right now 0: No pain Mild Discomforting Distressing Excruciating Horrible

Full Information

First Posted
July 28, 2016
Last Updated
April 25, 2017
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02863315
Brief Title
The Effects of Anodal tsDCS on Chronic Neuropathic Pain After SCI
Official Title
The Effects of Anodal Transcutaneous Spinal Direct Current Stimulation on Chronic Neuropathic Pain After Spinal Cord Injury: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Twenty patients with spinal cord injury and bilateral neuropathic pain received single sessions of both sham and anodal tsDCS (2 mA) over tenth thoracic vertebra for 20 min (reference electrodes on the head vertex). Treatment order was randomly assigned. A evaluator rated the pain using the visual analogue scale for pain, Patient Global Assessment and Present Pain Intensity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
tsDCS
Masking
Participant
Masking Description
tsDCS
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tsDCS
Arm Type
Experimental
Arm Description
In the tsDCS group, anodal tsDCS will be applied for 20 minutes.
Arm Title
sham
Arm Type
Placebo Comparator
Arm Description
In sham tsDCS group, the current of anodal tsDCS will be discontinued after 30 s while the power indicator remained on for 20 minutes.
Intervention Type
Device
Intervention Name(s)
tsDCS
Other Intervention Name(s)
DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric rating scale (NRS) for neuropathic pain
Description
On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable
Time Frame
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 Outcome Measure Information:
Title
Patient Global Assessment (PGA)
Description
One of the most widely used patient reported outcomes (PROs) & PGA reflects the global impact of the disease from the patient's perspective Markedly improved Moderately improved Mildly improved No change Mildly worse Moderately worse Markedly worse
Time Frame
Baseline PGA (average PGA over the preceding 24h), Change from Baseline PGA at 0, 60 and 120 minutes after the start of the stimulation
Title
Present Pain Intensity (PPI)
Description
Patient's subjective feeling of the intensity of pain right now 0: No pain Mild Discomforting Distressing Excruciating Horrible
Time Frame
Baseline PPI (average PPI over the preceding 24h), Change from Baseline PPI at 0, 60 and 120 minutes after the start of the stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Seoul National University
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25027640
Citation
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.
Results Reference
background
PubMed Identifier
21159430
Citation
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.
Results Reference
background
PubMed Identifier
24784477
Citation
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.
Results Reference
background
PubMed Identifier
18786856
Citation
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.
Results Reference
background

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The Effects of Anodal tsDCS on Chronic Neuropathic Pain After SCI

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