The Effects of Anodal tsDCS on Chronic Neuropathic Pain After SCI

Not Applicable

• Conditions: Spinal Cord Injury; Neuropathic Pain
• Interventions: Device: tsDCS

• Registration Number: NCT02863315
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-07-28
• Study Start: 2016-08
• Study First Submitted QC: 2016-08-07
• Study First Posted: 2016-08-11
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27
• Primary Completion: 2017-09
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
sham	tsDCS	In sham tsDCS group, the current of anodal tsDCS will be discontinued after 30 s while the power indicator remained on for 20 minutes.
tsDCS	tsDCS	In the tsDCS group, anodal tsDCS will be applied for 20 minutes.

Primary Outcome Measures

Name	Time	Method
Numeric rating scale (NRS) for neuropathic pain	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

Name	Time	Method
Patient Global Assessment (PGA)	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
Present Pain Intensity (PPI)	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

Trial Locations

Locations (1)

Seoul National University; 🇰🇷 Seoul, Korea, Republic of