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

Spinal Cord Injury Clinical Trial

Official title:

The Analgesic Effect of Transcranial Direct Current Stimulation Over the Primary Motor Cortex on Central Neuropathic Pain Patients With Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781065
• Other study ID #: 11-2008-010 SNUBH
• Status: Completed
• Phase: Phase 2
• First received: January 29, 2013
• Last updated: July 12, 2013
• Start date: March 2008
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2013
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• transcranial direct current stimulation

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. Epub 2006 Mar 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No