The Effects of Anodal tsDCS on Chronic Neuropathic Pain After SCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neuropathic Pain Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

tsDCS

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

tsDCS

Study Groups

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tsDCS

In the tsDCS group, anodal tsDCS will be applied for 20 minutes.

Group Type EXPERIMENTAL

tsDCS

Intervention Type DEVICE

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.

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.

Group Type PLACEBO_COMPARATOR

tsDCS

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No