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The Effects of Anodal tsDCS on Chronic Neuropathic Pain After SCI

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ClinicalTrials.gov Identifier: NCT02863315
Recruitment Status : Unknown
Verified April 2017 by Hyung-ik Shin, Seoul National University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 11, 2016
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Hyung-ik Shin, Seoul National University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Spinal Cord Injury Device: tsDCS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: tsDCS
Masking: Single (Participant)
Masking Description: tsDCS
Primary Purpose: Treatment
Official Title: The Effects of Anodal Transcutaneous Spinal Direct Current Stimulation on Chronic Neuropathic Pain After Spinal Cord Injury: Pilot Study
Study Start Date : August 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863315


Locations
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Korea, Republic of
Seoul National University
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital

Publications:
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Responsible Party: Hyung-ik Shin, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02863315     History of Changes
Other Study ID Numbers: 1604-007-752 SNUH
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Spinal Cord Injuries
Neuralgia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Peripheral Nervous System Diseases
Neuromuscular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms