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Completed

NCT Number: NCT01781065

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

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.

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Key information

Conditions

Neuropathic Pain Central Nervous System Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Trauma, Nervous System Wounds and Injuries

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-802, South Korea

About this study

  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

Other names: Iomed Phoresor II Auto

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2013
First posted
Jan 31, 2013
Registry last updated
Jul 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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