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The Effects of Transcranial Direct Current Stimulation on Central Pain in Patients With Spinal Cord Injury

Primary Purpose

Neuropathic Pain, Spinal Cord Injury

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • elapsed time since spinal cord injury more than 6 months
  • stable chronic pain for at least 3 preceding months
  • pain that was not attributable to cause other that neuropathic pain
  • pain that was resistant to various types of medications or physical or complementary medicine treatment

Exclusion Criteria:

  • any kind of metal implant in the head
  • heart disease including having a cardiac maker
  • family or personal history of epilepsy, or neuropsychiatric illness

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

transcranial direct current stimulation

Sham transcranial direct current stimulation

Arm Description

Anodal stimulation on motor cortex

Turn off after 10 s of stimulation

Outcomes

Primary Outcome Measures

Numeric rating scale for average pain over the preceding 24h

Secondary Outcome Measures

Patient global impression of change for pain

Full Information

First Posted
January 29, 2013
Last Updated
July 12, 2013
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01781065
Brief Title
The Effects of Transcranial Direct Current Stimulation on Central Pain in Patients With Spinal Cord Injury
Official Title
The Analgesic Effect of Transcranial Direct Current Stimulation Over the Primary Motor Cortex on Central Neuropathic Pain Patients With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the analgesic effect of transcranial direct current stimulation (tDCS) applied on motor cortex in patients with spinal cord injury who have chronic neuropathic pain.
Detailed Description
anodal stimulation of the primary motor cortex (M1) anode electrode: C3 (EEG 10/20 system) cathode electrode: contralateral supraorbital area constant current of 2mA intensity for 20 min twice a day with a more than 4 hours interval during of 2 weeks (from Monday to Friday, total 20 treatment session)

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
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transcranial direct current stimulation
Arm Type
Experimental
Arm Description
Anodal stimulation on motor cortex
Arm Title
Sham transcranial direct current stimulation
Arm Type
Sham Comparator
Arm Description
Turn off after 10 s of stimulation
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Other Intervention Name(s)
Iomed Phoresor II Auto
Primary Outcome Measure Information:
Title
Numeric rating scale for average pain over the preceding 24h
Time Frame
before the first tDCS session, and 1, 2, 4, 6 and 8 wk after the start of the stimulation
Secondary Outcome Measure Information:
Title
Patient global impression of change for pain
Time Frame
before the first tDCS session, and 1, 2, 4, 6, and 8 wk after the start of the stimulation
Other Pre-specified Outcome Measures:
Title
Pain interference in general daily life, mood and sleep
Time Frame
before the first tDCS session, and 1, 2, 4, 6, 8 wk after start of the stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: elapsed time since spinal cord injury more than 6 months stable chronic pain for at least 3 preceding months pain that was not attributable to cause other that neuropathic pain pain that was resistant to various types of medications or physical or complementary medicine treatment Exclusion Criteria: any kind of metal implant in the head heart disease including having a cardiac maker family or personal history of epilepsy, or neuropsychiatric illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyung Ik Shin
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-802
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
16564618
Citation
Fregni F, Boggio PS, Lima MC, Ferreira MJ, Wagner T, Rigonatti SP, Castro AW, Souza DR, Riberto M, Freedman SD, Nitsche MA, Pascual-Leone A. A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury. Pain. 2006 May;122(1-2):197-209. doi: 10.1016/j.pain.2006.02.023. Epub 2006 Mar 27.
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The Effects of Transcranial Direct Current Stimulation on Central Pain in Patients With Spinal Cord Injury

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