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

Soroka University Medical Center1 site in 1 countrySeptember 2016

ConditionsDiabetic Neuropathies Complex Regional Pain Syndrome Type II Resistant Peripheral Neuropathic Pain Chemotherapy Induced Pain Neuropathy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetic Neuropathies
Sponsor: Soroka University Medical Center
Locations: 1
Primary Endpoint: Changes in the amplitude of P300
Status: Withdrawn
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2016

End Date

October 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Soroka University Medical Center

Responsible Party

Principal Investigator

Pesach Shvartzman

Head Department of Family Medicine

Soroka University Medical Center

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:
•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 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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(15 min after and 120 min after each tDCS stimulation)
Changes in Pain Intensity-will be calculated as the difference in scores on the 11-point numerical pain rating scale (0-10)(15 min after and 120 min after each tDCS stimulation)