The Effects of Transcranial Direct Current Stimulation on Central Pain in Patients With Spinal Cord Injury
The Analgesic Effect of Transcranial Direct Current Stimulation Over the Primary Motor Cortex on Central Neuropathic Pain Patients With Spinal Cord Injury
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2008
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 29, 2013
CompletedFirst Posted
Study publicly available on registry
January 31, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJuly 15, 2013
July 1, 2013
11 months
January 29, 2013
July 12, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Numeric rating scale for average pain over the preceding 24h
before the first tDCS session, and 1, 2, 4, 6 and 8 wk after the start of the stimulation
Secondary Outcomes (1)
Patient global impression of change for pain
before the first tDCS session, and 1, 2, 4, 6, and 8 wk after the start of the stimulation
Other Outcomes (1)
Pain interference in general daily life, mood and sleep
before the first tDCS session, and 1, 2, 4, 6, 8 wk after start of the stimulation
Study Arms (2)
transcranial direct current stimulation
EXPERIMENTALAnodal stimulation on motor cortex
Sham transcranial direct current stimulation
SHAM COMPARATORTurn off after 10 s of stimulation
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- any kind of metal implant in the head
- heart disease including having a cardiac maker
- family or personal history of epilepsy, or neuropsychiatric illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-802, South Korea
Related Publications (1)
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.
PMID: 16564618BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyung Ik Shin
Seoul National University Bundang Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 29, 2013
First Posted
January 31, 2013
Study Start
March 1, 2008
Primary Completion
February 1, 2009
Study Completion
June 1, 2013
Last Updated
July 15, 2013
Record last verified: 2013-07