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tDCS and Pain Associated With Diabetic Neuropathy

Unknown statusNot applicableNCT04306289
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 real tDCS or sham, over the left dorsolateral prefrontal cortex (DLPFC) during 6 separated days. They will evaluate pain intensity, sleep quality, quality of life and anxiety and depression symptoms via clinical validated scales. The research question is whether tDCS can lessen neuropathic pain and improve sleep, psychological status and quality of life in patients with diabetic neuropathy. It is hypothesized, that less neuropathic pain and improved sleep, psychological status and quality of life after the tDCS sessions.

Study details

Official title
Effects of Transcranial Direct Current Stimulation (tDCS) on Pain Associated With Diabetic Neuropathy
Sponsor
University of Rome Tor Vergata
Start date
2020-06-01
Primary completion
2022-06-06
Sex
All
Age range
from 18 Years to 65 Years
Results posted
No results posted in this snapshot
Countries
Italy
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04306289