The Effects of Anodal tsDCS on Chronic Neuropathic Pain After SCI

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02863315
• Other study ID #: 1604-007-752 SNUH
• Status: Active, not recruiting
• Phase: N/A
• First received: July 28, 2016
• Last updated: April 25, 2017
• Start date: August 2016
• Est. completion date: October 2017

Study information

• Verified date: April 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: October 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View 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):370-5. doi: 10.1016/j.pain.2010.10.041. Epub 2010 Dec 14. — View 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. — View 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):2260-70. doi: 10.1016/j.clinph.2014.02.027. Epub 2014 Apr 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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; Markedly improved; Moderately improved; Mildly improved; No change; Mildly worse; Moderately worse; 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
Secondary	Present Pain Intensity (PPI)	Patient's subjective feeling of the intensity of pain right now; 0: No pain; Mild; Discomforting; Distressing; Excruciating; 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