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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

Primary Purpose

Diabetic Neuropathies, Complex Regional Pain Syndrome Type II, Resistant Peripheral Neuropathic Pain

Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
TDCS/sham procedure on five consecutive days
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pain and palliative care unit, Ben Gurion University of the Negev

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1-CRPS

2-DN

3-RPNP

4-CIPN

Arm Description

10 tDCS naïve patients with CRPS-related neuropathic pain in upper limb

20 tDCS naïve patients with diabetic neuropathy

20 tDCS naïve patients with resistant peripheral neuropathic pain

10 tDCS naïve patients with CIPN-Chemotherapy Induced Pain Neuropathy patients

Outcomes

Primary Outcome Measures

Changes in the amplitude of P300
Changes in the Latency of P300

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)
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

Full Information

First Posted
December 30, 2008
Last Updated
October 3, 2017
Sponsor
Soroka University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00815932
Brief 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 CRPS or Diabetic Neuropathy
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 Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Due to unfixable problem in the research machine we had to withdrawn from the study
Study Start Date
September 2016 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soroka University Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies, Complex Regional Pain Syndrome Type II, Resistant Peripheral Neuropathic Pain, Chemotherapy Induced Pain Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1-CRPS
Arm Type
Experimental
Arm Description
10 tDCS naïve patients with CRPS-related neuropathic pain in upper limb
Arm Title
2-DN
Arm Type
Experimental
Arm Description
20 tDCS naïve patients with diabetic neuropathy
Arm Title
3-RPNP
Arm Type
Experimental
Arm Description
20 tDCS naïve patients with resistant peripheral neuropathic pain
Arm Title
4-CIPN
Arm Type
Experimental
Arm Description
10 tDCS naïve patients with CIPN-Chemotherapy Induced Pain Neuropathy patients
Intervention Type
Device
Intervention Name(s)
TDCS/sham procedure on five consecutive days
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Title
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 Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Pain and palliative care unit, Ben Gurion University of the Negev
City
Beer-Sheva
ZIP/Postal Code
84105
Country
Israel

12. IPD Sharing Statement

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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

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