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
NCT ID: NCT00815932
Last Updated: 2017-10-05
Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2016-09-30
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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1-CRPS
10 tDCS naïve patients with CRPS-related neuropathic pain in upper limb
TDCS/sham procedure on five consecutive days
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.
2-DN
20 tDCS naïve patients with diabetic neuropathy
TDCS/sham procedure on five consecutive days
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.
3-RPNP
20 tDCS naïve patients with resistant peripheral neuropathic pain
TDCS/sham procedure on five consecutive days
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.
4-CIPN
10 tDCS naïve patients with CIPN-Chemotherapy Induced Pain Neuropathy patients
TDCS/sham procedure on five consecutive days
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.
Interventions
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TDCS/sham procedure on five consecutive days
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.
Eligibility Criteria
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Inclusion Criteria
* 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:
1. Continuing pain which is disproportionate to any inciting event or for CRPS diagnosis.
2. 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.
3. 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Soroka University Medical Center
OTHER
Responsible Party
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Pesach Shvartzman
Head Department of Family Medicine
Locations
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Pain and palliative care unit, Ben Gurion University of the Negev
Beersheba, , Israel
Countries
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Other Identifiers
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SOR477808CTIL
Identifier Type: -
Identifier Source: org_study_id