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Due to unfixable problem in the research machine we had to withdrawn from the study
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This is a controlled trial designed to determine short- and long-term effects of repeated tDCS on the P300 component of event-related evoked potentials in patients with chronic neuropathic pain due to Complex regional Pain Syndrome (CRPS) or diabetic neuropathy as compared with healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-CRPS | Experimental | 10 tDCS naïve patients with CRPS-related neuropathic pain in upper limb |
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| 2-DN | Experimental | 20 tDCS naïve patients with diabetic neuropathy |
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| 3-RPNP | Experimental | 20 tDCS naïve patients with resistant peripheral neuropathic pain |
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| 4-CIPN | Experimental | 10 tDCS naïve patients with CIPN-Chemotherapy Induced Pain Neuropathy patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TDCS/sham procedure on five consecutive days | Device | The latency and amplitude of P300, subjective pain intensity, and pain thresholds for tactile and thermal stimuli will be determined at before and 15 min and 120 min after the 1st and 5th tDCS/sham procedure, To receive tDCS/sham treatment, two electrodes will be placed on the patient´s skull (for details see section Methods) and the patient will rest for 5 min. After that, the patient will receive 20 minutes of 2 mA tDCS/sham. Subjective pain intensity, and pain thresholds for tactile and thermal stimuli will be determined before-, 15 min after and 120 min after each tDCS/Sham procedure. At the 1st and 5th tDCS/Sham session, the latency and amplitude of P300 will be determined before-, 15 min after and 120 min after the tDCS/sham procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the amplitude of P300 | 15 min after and 120 min after the 1st tDCS, 15 min after and 120 min after the 5st tDCS, and at the follow up 1 week after the 5th tDCS. | |
| Changes in the Latency of P300 | 15 min after and 120 min after the 1st tDCS, 15 min after and 120 min after the 5st tDCS, and at the follow up 1 week after the 5th tDCS. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Pain Intensity-will be calculated as the difference in scores on the 11-point numerical pain rating scale (0-10) | 15 min after and 120 min after each tDCS stimulation | |
| Changes in Pain Thresholds for Tactile and Thermal Stimuli will be calculated as the difference between ratings obtained form pain threshold measurements before- and after tDCS |
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Inclusion Criteria:
An affected upper limb or lower limb
Diagnosed as : Diabetic neuropathy, Complex Regional Pain Syndrome (CRPS), Chemotherapy Induced Pain Neuropathy (CIPN), Peripheral Neuropathy.
Have not responded to at least two medications of the following groups: Opioids. Tricyclics, SSRI, SNRI, Pregabalin, Gabapentin, Anticonvulsants.
Positive LANSS or CRPS criteria as follows:
Must meet resistant neuropathic pain criteria - pain that is neuropathic in characters that at least two neuropathic medications not from the same group have been tried for at least a month without improvement or severe side-effects were experienced. Resistant neuropathic pain with a score for "average pain in the last 24 hours" ≥4 on a numeric scale 0-10
tDCS naive
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain and palliative care unit, Ben Gurion University of the Negev | Beersheba | 84105 | Israel |
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| 15 min after and 120 min after each tDCS stimulation |
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D002422 | Causalgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D020918 | Complex Regional Pain Syndromes |
| D001342 | Autonomic Nervous System Diseases |
| D009437 | Neuralgia |
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