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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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2008
CompletedFirst Posted
Study publicly available on registry
December 31, 2008
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedOctober 5, 2017
October 1, 2017
1.1 years
December 30, 2008
October 3, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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
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
Study Arms (4)
1-CRPS
EXPERIMENTAL10 tDCS naïve patients with CRPS-related neuropathic pain in upper limb
2-DN
EXPERIMENTAL20 tDCS naïve patients with diabetic neuropathy
3-RPNP
EXPERIMENTAL20 tDCS naïve patients with resistant peripheral neuropathic pain
4-CIPN
EXPERIMENTAL10 tDCS naïve patients with CIPN-Chemotherapy Induced Pain Neuropathy patients
Interventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pain and palliative care unit, Ben Gurion University of the Negev
Beersheba, 84105, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head Department of Family Medicine
Study Record Dates
First Submitted
December 30, 2008
First Posted
December 31, 2008
Study Start
September 1, 2016
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
October 5, 2017
Record last verified: 2017-10