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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
This study is not yet open for participant recruitment.
Verified May 2016 by Pesach Shvartzman, Soroka University Medical Center
Sponsor:
Soroka University Medical Center
Information provided by (Responsible Party):
Pesach Shvartzman, Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00815932
First received: December 30, 2008
Last updated: May 2, 2016
Last verified: May 2016
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Purpose
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 | Intervention |
|---|---|
| Diabetic Neuropathies Complex Regional Pain Syndrome Type II Resistant Peripheral Neuropathic Pain Chemotherapy Induced Pain Neuropathy | Device: TDCS/sham procedure on five consecutive days |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (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 |
Resource links provided by NLM:
Further study details as provided by Pesach Shvartzman, Soroka University Medical Center:
Primary Outcome Measures:
- 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 Outcome Measures:
- 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 ]
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2016 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | May 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| 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:
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815932
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815932
Contacts
| Contact: Pesach Shvartzman, MD | 972-8-6477429 | spesah@bgu.ac.il |
Locations
| Israel | |
| Pain and palliative care unit, Ben Gurion University of the Negev | Not yet recruiting |
| Beer-Sheva, Israel, 84105 | |
| Contact: Pesach Shvartzman, MD 972-8-6477429 spesah@bgu.ac.il | |
| Principal Investigator: Pesach Shvartzman, MD | |
Sponsors and Collaborators
Soroka University Medical Center
More Information
| 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 |
| Study First Received: | December 30, 2008 |
| Last Updated: | May 2, 2016 |
Additional relevant MeSH terms:
|
Complex Regional Pain Syndromes Reflex Sympathetic Dystrophy Syndrome Peripheral Nervous System Diseases Neuralgia Diabetic Neuropathies 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 |
ClinicalTrials.gov processed this record on June 26, 2017