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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyung-Ik Shin, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01781065
First received: January 29, 2013
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Neuropathic Pain
Spinal Cord Injury
Device: transcranial direct current stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Analgesic Effect of Transcranial Direct Current Stimulation Over the Primary Motor Cortex on Central Neuropathic Pain Patients With Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: March 2008
Study Completion Date: June 2013
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: transcranial direct current stimulation
Anodal stimulation on motor cortex
Device: transcranial direct current stimulation
Other Name: Iomed Phoresor II Auto
Sham Comparator: Sham transcranial direct current stimulation
Turn off after 10 s of stimulation
Device: transcranial direct current stimulation
Other Name: Iomed Phoresor II Auto

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)
  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01781065

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-802
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Hyung Ik Shin Seoul National University Bundang Hospital
  More Information

Publications:
Responsible Party: Hyung-Ik Shin, Associate Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01781065     History of Changes
Other Study ID Numbers: 11-2008-010 SNUBH
Study First Received: January 29, 2013
Last Updated: July 12, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Spinal Cord Injuries
Neuralgia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014