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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

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ClinicalTrials.gov Identifier: NCT00815932
Recruitment Status : Withdrawn (Due to unfixable problem in the research machine we had to withdrawn from the study)
First Posted : December 31, 2008
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Pesach Shvartzman, Soroka University Medical Center

December 30, 2008
December 31, 2008
October 5, 2017
September 2016
October 2017   (Final data collection date for primary outcome measure)
  • Changes in the amplitude of P300 [ Time Frame: 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 [ Time Frame: 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. ]
Same as current
Complete list of historical versions of study NCT00815932 on ClinicalTrials.gov Archive Site
  • Changes in Pain Intensity-will be calculated as the difference in scores on the 11-point numerical pain rating scale (0-10) [ Time Frame: 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 [ Time Frame: 15 min after and 120 min after each tDCS stimulation ]
Same as current
Not Provided
Not Provided
 
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
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
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Diabetic Neuropathies
  • Complex Regional Pain Syndrome Type II
  • Resistant Peripheral Neuropathic Pain
  • Chemotherapy Induced Pain Neuropathy
Device: 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.
  • Experimental: 1-CRPS
    10 tDCS naïve patients with CRPS-related neuropathic pain in upper limb
    Intervention: Device: TDCS/sham procedure on five consecutive days
  • Experimental: 2-DN
    20 tDCS naïve patients with diabetic neuropathy
    Intervention: Device: TDCS/sham procedure on five consecutive days
  • Experimental: 3-RPNP
    20 tDCS naïve patients with resistant peripheral neuropathic pain
    Intervention: Device: TDCS/sham procedure on five consecutive days
  • Experimental: 4-CIPN
    10 tDCS naïve patients with CIPN-Chemotherapy Induced Pain Neuropathy patients
    Intervention: Device: TDCS/sham procedure on five consecutive days
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
40
October 2017
October 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00815932
SOR477808CTIL
Not Provided
Not Provided
Not Provided
Pesach Shvartzman, Soroka University Medical Center
Soroka University Medical Center
Not Provided
Not Provided
Soroka University Medical Center
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP