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
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ClinicalTrials.gov Identifier: NCT00815932 |
Recruitment Status
:
Withdrawn
(Due to unfixable problem in the research machine we had to withdrawn from the study)
First Posted
: December 31, 2008
Last Update Posted
: October 5, 2017
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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 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 |
Arm | Intervention/treatment |
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Experimental: 1-CRPS
10 tDCS naïve patients with CRPS-related neuropathic pain in upper limb
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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.
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Experimental: 2-DN
20 tDCS naïve patients with diabetic neuropathy
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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.
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Experimental: 3-RPNP
20 tDCS naïve patients with resistant peripheral neuropathic pain
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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.
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Experimental: 4-CIPN
10 tDCS naïve patients with CIPN-Chemotherapy Induced Pain Neuropathy patients
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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.
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- 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. ]
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00815932
Israel | |
Pain and palliative care unit, Ben Gurion University of the Negev | |
Beer-Sheva, Israel, 84105 |
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 Key Record Dates |
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 |