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Neuropathic PainNCT02863315

The Effects of Anodal tsDCS on Chronic Neuropathic Pain After SCI

A study testing tsDCS in people with Neuropathic Pain and Spinal Cord Injury, run by Seoul National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 90 years
Conditions the study is for
Neuropathic Pain, Spinal Cord Injury
What is being tested?
tsDCS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10 participants
Where
1 siteSouth Korea
Study dates
Aug 2016to Oct 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • cervical or upper thoracic complete motor spinal cord injury, at least 6 months after SCI, 20<=age<90
  • neuropathic pain (LANSS score >= 12), stable chronic pain for at least the three preceding months but not over 5 years
  • 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
  • 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)
  • informed consent

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University

    Seoul, 03080

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
tsDCS
Medical subject headings
Neuralgia, Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tsDCSDevice

    Also called DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany)

    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.

Study groups in NCT02863315
Study groupRoleWhat they receive
tsDCSExperimentalIn the tsDCS group, anodal tsDCS will be applied for 20 minutes.
Receives: Device: tsDCS
shamPlacebo comparatorIn sham tsDCS group, the current of anodal tsDCS will be discontinued after 30 s while the power indicator remained on for 20 minutes.
Receives: Device: tsDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numeric rating scale (NRS) for neuropathic pain

    On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable

    Measured: 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 outcomes (2)

  1. Patient Global Assessment (PGA)

    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

    Measured: Baseline PGA (average PGA over the preceding 24h), Change from Baseline PGA at 0, 60 and 120 minutes after the start of the stimulation

  2. Present Pain Intensity (PPI)

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

    0: No pain

    1. Mild
    2. Discomforting
    3. Distressing
    4. Excruciating
    5. Horrible

    Measured: Baseline PPI (average PPI over the preceding 24h), Change from Baseline PPI at 0, 60 and 120 minutes after the start of the stimulation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionSep 2017 (estimated)
  4. Study completionOct 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
tsDCS
Masking
Single blind
Who is masked
Participant
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02863315
Sponsor's protocol ID
1604-007-752 SNUH
Status last verified
Apr 2017
First submitted
28 Jul 2016
Last updated
27 Apr 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Ngernyam N, Jensen MP, Arayawichanon P, Auvichayapat N, Tiamkao S, Janjarasjitt S, Punjaruk W, Amatachaya A, Aree-uea B, Auvichayapat P. The effects of transcranial direct current stimulation in patients with neuropathic pain from spinal cord injury. Clin Neurophysiol. 2015 Feb;126(2):382-90. doi: 10.1016/j.clinph.2014.05.034. Epub 2014 Jun 21.

    PubMed 25027640

  • Cogiamanian F, Vergari M, Schiaffi E, Marceglia S, Ardolino G, Barbieri S, Priori A. Transcutaneous spinal cord direct current stimulation inhibits the lower limb nociceptive flexion reflex in human beings. Pain. 2011 Feb;152(2):370-375. doi: 10.1016/j.pain.2010.10.041. Epub 2010 Dec 14.

    PubMed 21159430

  • Parazzini M, Fiocchi S, Liorni I, Rossi E, Cogiamanian F, Vergari M, Priori A, Ravazzani P. Modeling the current density generated by transcutaneous spinal direct current stimulation (tsDCS). Clin Neurophysiol. 2014 Nov;125(11):2260-2270. doi: 10.1016/j.clinph.2014.02.027. Epub 2014 Apr 3.

    PubMed 24784477

  • Cogiamanian F, Vergari M, Pulecchi F, Marceglia S, Priori A. Effect of spinal transcutaneous direct current stimulation on somatosensory evoked potentials in humans. Clin Neurophysiol. 2008 Nov;119(11):2636-40. doi: 10.1016/j.clinph.2008.07.249. Epub 2008 Sep 10.

    PubMed 18786856

Questions about this trial

What is this clinical trial studying?

A study testing tsDCS in people with Neuropathic Pain and Spinal Cord Injury, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02863315, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.

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