Status:
WITHDRAWN
The Effect of Transcranial Direct Current Stimulation (t-DCS) On the P300 Component of Event-Related Potentials in Patients With Chronic Neuropathic Pain Due To CRPS or Diabetic Neuropathy
Lead Sponsor:
Soroka University Medical Center
Conditions:
Diabetic Neuropathies
Complex Regional Pain Syndrome Type II
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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:
- Continuing pain which is disproportionate to any inciting event or for CRPS diagnosis.
- Must report at least one symptom (symptoms here are reports by subject) in each of the four following categories: sensory, vasomotor, sudomotor/edema, motor/trophic.
- Must display at least one sign (signs here refer to objective observation/testing) in in each of the four following categories: sensory, vasomotor, sudomotor/edema, motor/trophic;
- 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
- Serious health problems other than CRPS or resistant neuropathic pain (e.g. uncontrolled hypertension, uncontrolled diabetes, heart failure)
- Pain/painful conditions unrelated to CRPS or neuropathic pain
- Pregnancy
- History of seizures/epilepsy
- Implanted device (e.g. pacemaker)
- Active illicit drug/alcohol abuse
- Unable to follow directions or complete tools in Hebrew
- Previous exposure to tDCS stimulation
Key Trial Info
Start Date :
September 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00815932
Start Date
September 1 2016
End Date
October 1 2017
Last Update
October 5 2017
Active Locations (1)
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1
Pain and palliative care unit, Ben Gurion University of the Negev
Beersheba, Israel, 84105