Status:
UNKNOWN
tDCS and Pain Associated With Diabetic Neuropathy
Lead Sponsor:
University of Rome Tor Vergata
Conditions:
Diabetic Neuropathies
Chronic Pain
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the effects of anodal transcranial direct current stimulation (tDCS) on pain intensity associated with diabetic neuropathy. The investigators will conduct r...
Detailed Description
Background: Worldwide, the prevalence of diabetes mellitus (DM) and its chronic complications are reaching epidemic proportions. By 2045 DM expected to affect 629 million persons. Diabetic neuropathy ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patient diagnosed with painful diabetic peripheral neuropathy (PDPN) components with DN4 score ≥ 4/10, and chronic pain with an intensity of at least VAS\> 4/10.
- Onset of neuropathic PDPN pain for at least 6 months.
- Pain intensity as measured by VAS\> 4/10 in the week preceding inclusion in the study.
- drug-resistant patients who have no pain reduction of 50% or an improvement of at least 2 points in the Patient Global Impression of Change, having used all the classes of drugs indicated as a first, second or third line.
- Absence of glycemic de-compensation with HbA1c values \<9% in the previous 6 months.
- Stability of glycemic control with changes in HbA1c in the last 6 months of less than 2%.
- Exclusion Criteria
- Neurological comorbidities.
- Presence of contraindications to the use of electrotherapy (pacemaker, epilepsy, etc ...).
- Pregnancy.
- Previous neurosurgical interventions.
- psychiatric conditions.
- Cognitive impairments ( Mini-Mental Status exam (MMSE) \<24).
- Presence of red flags for pain: tumors, spine fractures, non-neuropathic pain difficult to distinguish from that of the PDPN, neuropathic pain from a cause other than the PDPN.
- Severe comorbidities such as advanced renal failure, heart failure, respiratory failure.
Exclusion
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04306289
Start Date
June 1 2020
End Date
September 1 2022
Last Update
August 10 2021
Active Locations (1)
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1
Prof. Silvia Natoli
Rome, Lazio, Italy, 00133