Clinical trial NCT02863315: The Effects of Anodal tsDCS on Chronic Neuropathic Pain After SCI
Official title: The Effects of Anodal Transcutaneous Spinal Direct Current Stimulation on Chronic Neuropathic Pain After Spinal Cord Injury: Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuropathic Pain
Spinal Cord Injury
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: tsDCS
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Numeric rating scale (NRS) for neuropathic pain
timeFrame: 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:
measure: Patient Global Assessment (PGA)
timeFrame: Baseline PGA (average PGA over the preceding 24h), Change from Baseline PGA at 0, 60 and 120 minutes after the start of the stimulation
measure: Present Pain Intensity (PPI)
timeFrame: Baseline PPI (average PPI over the preceding 24h), Change from Baseline PPI at 0, 60 and 120 minutes after the start of the stimulation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.