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

NCT ID: NCT01781065

Last Updated: 2013-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2013-06-30

Brief Summary

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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

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* 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)

Conditions

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Neuropathic Pain Spinal Cord Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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transcranial direct current stimulation

Anodal stimulation on motor cortex

Group Type EXPERIMENTAL

transcranial direct current stimulation

Intervention Type DEVICE

Sham transcranial direct current stimulation

Turn off after 10 s of stimulation

Group Type SHAM_COMPARATOR

transcranial direct current stimulation

Intervention Type DEVICE

Interventions

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transcranial direct current stimulation

Intervention Type DEVICE

Other Intervention Names

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Iomed Phoresor II Auto

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyung-Ik Shin

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyung Ik Shin

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 16564618 (View on PubMed)

Other Identifiers

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11-2008-010 SNUBH

Identifier Type: -

Identifier Source: org_study_id

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