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

Diabetic Neuropathies Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00815932
• Other study ID #: SOR477808CTIL
• Status: Withdrawn
• Phase: N/A
• First received: December 30, 2008
• Last updated: October 3, 2017
• Start date: September 2016
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Causalgia
• Chemotherapy Induced Pain Neuropathy
• Complex Regional Pain Syndrome Type II
• Complex Regional Pain Syndromes
• Diabetic Neuropathies
• Neuralgia
• Peripheral Nervous System Diseases
• Reflex Sympathetic Dystrophy
• Resistant Peripheral Neuropathic Pain
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Israel	Pain and palliative care unit, Ben Gurion University of the Negev	Beer-Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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
Secondary	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