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

Not Applicable

Withdrawn

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

• Registration Number: NCT00815932
• Lead Sponsor: Soroka University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-30
• Study First Submitted QC: 2008-12-30
• Study First Posted: 2008-12-31
• Study Start: 2016-09
• Status Verified: 2017-10
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Last Update Submitted: 2017-10-03
• Last Update Posted: 2017-10-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3-RPNP	TDCS/sham procedure on five consecutive days	20 tDCS naïve patients with resistant peripheral neuropathic pain
1-CRPS	TDCS/sham procedure on five consecutive days	10 tDCS naïve patients with CRPS-related neuropathic pain in upper limb
2-DN	TDCS/sham procedure on five consecutive days	20 tDCS naïve patients with diabetic neuropathy
4-CIPN	TDCS/sham procedure on five consecutive days	10 tDCS naïve patients with CIPN-Chemotherapy Induced Pain Neuropathy patients

Primary Outcome Measures

Name	Time	Method
Changes in the amplitude of P300	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	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pain and palliative care unit, Ben Gurion University of the Negev; 🇮🇱 Beer-Sheva, Israel