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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Diabetic Neuropathies; Complex Regional Pain Syndrome Type II; Resistant Peripheral Neuropathic Pain; Chemotherapy Induced Pain Neuropathy	Device: TDCS/sham procedure on five consecutive days	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, 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
Study Start Date :	September 2016
Actual Primary Completion Date :	October 2017
Actual Study Completion Date :	October 2017

Arms and Interventions

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Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. 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. ]
2. 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 Outcome Measures :

1. 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 ]
2. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Locations

Israel
Pain and palliative care unit, Ben Gurion University of the Negev
Beer-Sheva, Israel, 84105

Sponsors and Collaborators

Soroka University Medical Center

More Information

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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
First Posted:	December 31, 2008
Last Update Posted:	October 5, 2017
Last Verified:	October 2017

Additional relevant MeSH terms:

Syndrome; Peripheral Nervous System Diseases; Neuralgia; Diabetic Neuropathies; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Causalgia; Disease; Pathologic Processes	Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Autonomic Nervous System Diseases