The Effects of Anodal tsDCS on Chronic Neuropathic Pain After SCI

April 25, 2017 updated by: Hyung-ik Shin, Seoul National University Hospital

The Effects of Anodal Transcutaneous Spinal Direct Current Stimulation on Chronic Neuropathic Pain After Spinal Cord Injury: Pilot Study

The purpose of this study is to evaluate the analgesic effect of transcutaneous spinal direct current stimulation (tsDCS) applied on spinal cord in patients with spinal cord injury who have chronic neuropathic pain.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Twenty patients with spinal cord injury and bilateral neuropathic pain received single sessions of both sham and anodal tsDCS (2 mA) over tenth thoracic vertebra for 20 min (reference electrodes on the head vertex). Treatment order was randomly assigned. A evaluator rated the pain using the visual analogue scale for pain, Patient Global Assessment and Present Pain Intensity.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. cervical or upper thoracic complete motor spinal cord injury, at least 6 months after SCI, 20<=age<90
  2. neuropathic pain (LANSS score >= 12), stable chronic pain for at least the three preceding months but not over 5 years
  3. score higher than or equal to 4 cm (0 cm = 'no pain' and 10 cm = 'worst possible pain') on the visual ana- logue scale (VAS) for pain perception at the baseline/start of the treatment
  4. refractoriness to drugs for pain relief - such as tricyclic antidepressants, antiepileptic drugs, and/or narcot- ics (pain resistant to at least two of these drugs supplied in ade- quate dosages for 6 months)
  5. informed consent

Exclusion Criteria:

  1. patients with any clinically significant or unstable medical or progressive neurologic disorder
  2. contraindication for electrial stimulation such as pacemaker implant
  3. Women of childbearing age or pregnancy
  4. significant cognitive deficit
  5. Syringomyelia
  6. neuropsychiatric comorbidity
  7. depressive disorder (as indicated by a score of 10 greater on the Beck Depression Inventory)
  8. history of substance abuse
  9. skin defect under the electrodes
  10. progressive neurological disease or other secondary conditions that could impact neuropathic pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tsDCS
In the tsDCS group, anodal tsDCS will be applied for 20 minutes.
Device: tsDCS

Both groups use the same DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany).

In the tsDCS group, anode electrode is placed over tenth thoracic vertebra to target spinal cord with 2mA for 20 min, and the cathode (reference) electrode on the head vertex (in the Cz location according to the 10-20 EEG system)

In sham tsDCS group, anode electrode is placed over tenth thoracic vertebra to target spinal cord with 2mA for 30s, and the cathode (reference) electrode on the head vertex (in the Cz location according to the 10-20 EEG system). The current was discontinued after 30 s while the power indicator remained on.

Other Names:
  • DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany)
Placebo Comparator: sham
In sham tsDCS group, the current of anodal tsDCS will be discontinued after 30 s while the power indicator remained on for 20 minutes.
Device: tsDCS

Both groups use the same DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany).

In the tsDCS group, anode electrode is placed over tenth thoracic vertebra to target spinal cord with 2mA for 20 min, and the cathode (reference) electrode on the head vertex (in the Cz location according to the 10-20 EEG system)

In sham tsDCS group, anode electrode is placed over tenth thoracic vertebra to target spinal cord with 2mA for 30s, and the cathode (reference) electrode on the head vertex (in the Cz location according to the 10-20 EEG system). The current was discontinued after 30 s while the power indicator remained on.

Other Names:
  • DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric rating scale (NRS) for neuropathic pain
Time Frame: Baseline NRS (average NRS over the preceding 24h), Change from Baseline NRS at 0, 60 and 120 minutes after the start of the stimulation
On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable
Baseline NRS (average NRS over the preceding 24h), Change from Baseline NRS at 0, 60 and 120 minutes after the start of the stimulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Global Assessment (PGA)
Time Frame: Baseline PGA (average PGA over the preceding 24h), Change from Baseline PGA at 0, 60 and 120 minutes after the start of the stimulation

One of the most widely used patient reported outcomes (PROs) & PGA reflects the global impact of the disease from the patient's perspective

  1. Markedly improved
  2. Moderately improved
  3. Mildly improved
  4. No change
  5. Mildly worse
  6. Moderately worse
  7. Markedly worse
Baseline PGA (average PGA over the preceding 24h), Change from Baseline PGA at 0, 60 and 120 minutes after the start of the stimulation
Present Pain Intensity (PPI)
Time Frame: Baseline PPI (average PPI over the preceding 24h), Change from Baseline PPI at 0, 60 and 120 minutes after the start of the stimulation

Patient's subjective feeling of the intensity of pain right now

0: No pain

  1. Mild
  2. Discomforting
  3. Distressing
  4. Excruciating
  5. Horrible
Baseline PPI (average PPI over the preceding 24h), Change from Baseline PPI at 0, 60 and 120 minutes after the start of the stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

August 7, 2016

First Posted (Estimate)

August 11, 2016

Study Record Updates

Last Update Posted (Actual)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1604-007-752 SNUH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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