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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Soroka University Medical Center
Sponsor:
Information provided by (Responsible Party):
Pesach Shvartzman, Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00815932
First received: December 30, 2008
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Diabetic Neuropathies
Complex Regional Pain Syndrome Type II
Resistant Peripheral Neuropathic Pain
Chemotherapy Induced Pain Neuropathy
Device: TDCS/sham procedure on five consecutive days

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1-CRPS
10 tDCS naïve patients with CRPS-related neuropathic pain in upper limb
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: 2-DN
20 tDCS naïve patients with diabetic 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: 3-RPNP
20 tDCS naïve patients with resistant peripheral neuropathic pain
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: 4-CIPN
10 tDCS naïve patients with CIPN-Chemotherapy Induced Pain Neuropathy patients
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00815932

Contacts
Contact: Pesach Shvartzman, MD 972-8-6477429 spesah@bgu.ac.il

Locations
Israel
Pain and palliative care unit, Ben Gurion University of the Negev Not yet recruiting
Beer-Sheva, Israel, 84105
Contact: Pesach Shvartzman, MD    972-8-6477429    spesah@bgu.ac.il   
Principal Investigator: Pesach Shvartzman, MD         
Sponsors and Collaborators
Soroka University Medical Center
  More Information

No publications provided

Responsible Party: Pesach Shvartzman, Head Department of Family Medicine, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00815932     History of Changes
Other Study ID Numbers: SOR477808CTIL
Study First Received: December 30, 2008
Last Updated: July 11, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Diabetic Neuropathies
Causalgia
Neuralgia
Somatoform Disorders
Peripheral Nervous System Diseases
Complex Regional Pain Syndromes
Autonomic Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014