Diabetic NeuropathiesNCT00815932
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
A study of Diabetic Neuropathies and Complex Regional Pain Syndrome Type II, run by Soroka University Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathies, Complex Regional Pain Syndrome Type II, Resistant Peripheral Neuropathic Pain
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Pain and palliative care unit, Ben Gurion University of the Negev
Beersheba, 84105
About this study
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
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.
- Conditions
- Diabetic Neuropathies, Complex Regional Pain Syndrome Type II, Resistant Peripheral Neuropathic Pain, Chemotherapy Induced Pain Neuropathy
- Being tested
- TDCS/sham procedure on five consecutive days
- Medical subject headings
- Diabetic Neuropathies, Causalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDCS/sham procedure on five consecutive daysDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 1-CRPS | Experimental | 10 tDCS naïve patients with CRPS-related neuropathic pain in upper limb Receives: Device: TDCS/sham procedure on five consecutive days |
| 2-DN | Experimental | 20 tDCS naïve patients with diabetic neuropathy Receives: Device: TDCS/sham procedure on five consecutive days |
| 3-RPNP | Experimental | 20 tDCS naïve patients with resistant peripheral neuropathic pain Receives: Device: TDCS/sham procedure on five consecutive days |
| 4-CIPN | Experimental | 10 tDCS naïve patients with CIPN-Chemotherapy Induced Pain Neuropathy patients Receives: Device: TDCS/sham procedure on five consecutive days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the amplitude of P300
Measured: 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
Measured: 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)
Measured: 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
Measured: 15 min after and 120 min after each tDCS stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2008 (estimated)
- Study startSep 2016
- Primary completionOct 2017
- Study completionOct 2017
Why it stopped: Due to unfixable problem in the research machine we had to withdrawn from the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pesach Shvartzman, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815932
- Sponsor's protocol ID
- SOR477808CTIL
- Status last verified
- Oct 2017
- First submitted
- 30 Dec 2008
- Last updated
- 5 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00815932
- Acronym / sponsor ID
- SOR477808CTIL
- Conditions
- Diabetic Neuropathies, Complex Regional Pain Syndrome Type II, Resistant Peripheral Neuropathic Pain, Chemotherapy Induced Pain Neuropathy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to unfixable problem in the research machine we had to withdrawn from the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 31 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1-CRPS | Experimental | Device: TDCS/sham procedure on five consecutive days10 tDCS naïve patients with CRPS-related neuropathic pain in upper limb |
| 2-DN | Experimental | Device: TDCS/sham procedure on five consecutive days20 tDCS naïve patients with diabetic neuropathy |
| 3-RPNP | Experimental | Device: TDCS/sham procedure on five consecutive days20 tDCS naïve patients with resistant peripheral neuropathic pain |
| 4-CIPN | Experimental | Device: TDCS/sham procedure on five consecutive days10 tDCS naïve patients with CIPN-Chemotherapy Induced Pain Neuropathy patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TDCS/sham procedure on five consecutive daysThe 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. | Device | 1-CRPS, 2-DN, 3-RPNP, 4-CIPN |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diabetic Neuropathies and Complex Regional Pain Syndrome Type II, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2017.