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

Phase 2

Completed

• Conditions: Neuropathic Pain; Spinal Cord Injury
• Interventions: Device: transcranial direct current stimulation

• Registration Number: NCT01781065
• Lead Sponsor: Seoul National University Bundang Hospital

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)

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-02
• Study First Submitted: 2013-01-29
• Study First Submitted QC: 2013-01-29
• Study First Posted: 2013-01-31
• Study Completion: 2013-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-12
• Last Update Posted: 2013-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transcranial direct current stimulation	transcranial direct current stimulation	Anodal stimulation on motor cortex
Sham transcranial direct current stimulation	transcranial direct current stimulation	Turn off after 10 s of stimulation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of