Clinical trial NCT00815932: 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
Official title: 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 Complex Regional Pain Syndrome (CRPS) or Diabetic Neuropathy-A PILOT, DOUBLE-BLIND, SHAM-CONTROLLED, CROSS-OVER STUDY
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetic Neuropathies
Complex Regional Pain Syndrome Type II
Resistant Peripheral Neuropathic Pain
Chemotherapy Induced Pain Neuropathy
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2008-12-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 Complex regional Pain Syndrome (CRPS) or diabetic neuropathy as compared with healthy subjects.


Eligibility criteria: 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:

  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:

* 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

Primary outcomes:
measure: Changes in the amplitude of P300
timeFrame: 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: Changes in the Latency of P300
timeFrame: 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.
Secondary outcomes:
measure: Changes in Pain Intensity-will be calculated as the difference in scores on the 11-point numerical pain rating scale (0-10)
timeFrame: 15 min after and 120 min after each tDCS stimulation
measure: 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
timeFrame: 15 min after and 120 min after each tDCS stimulation
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Pain and palliative care unit, Ben Gurion University of the Negev
Study officials:
References: