tDCS and Pain Associated With Diabetic Neuropathy

NCT04306289 | Unknown DMC

• 1 other identifier: University of Rome Tor Vergata
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Diabetic Neuropathies; Chronic Pain

Keywords

chronic pain; transcranial direct current stimulation; Diabetic Neuropathy; Quality of life

Outcome Measures

Primary Outcomes (1)

• Changes in Pain severity

  Changes in Pain severity will be measured by Brief Pain Inventory (BPI) to determine the effect of anodal Transcranial direct current stimulation (tDCS) in reducing pain of subjects with pain associated with diabetic neuropathy.

  Measured at baseline and immediately after the intervention

Secondary Outcomes (7)

• Changes in Depression severity

  Measured at baseline and immediately after the intervention

• Changes in Anxiety severity

  Measured at baseline and immediately after the intervention

• Changes in sleep quality

  Measured at baseline and immediately after the intervention

• Changes in Quality of Life

  Measured at baseline and immediately after the intervention

• Changes in Pain related to disability

  Measured at baseline and immediately after the intervention

Study Arms (2)

Real tDCS

ACTIVE COMPARATOR

The participant will receive anodal tDCS for 20 min at an intensity of 2 mA while seated comfortably and quietly in a room. The intensity will start at 0 mA and will be incrementally increased to 2mA over the initial 30 seconds. At the 19:30 minute time point, the current will gradually be reduced from 2 mA to 0 mA.

Device: transcranial direct current stimulation

Sham tDCS

SHAM COMPARATOR

Identical to the real tDCS, except the participants will only receive the initial 30 seconds of ramp-up, after which the current will be set to 0 for the remainder of the 20 minutes.

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulation DEVICE

Transcranial direct current stimulation (tDCS) is a noninvasive technique of neuronal modulation that has been used in different neurological conditions, neuropathic pain.

Real tDCS; Sham tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

Prof. Silvia Natoli

Rome, Lazio, 00133, Italy

RECRUITING

Related Publications (15)

• Dyck PJ, Kratz KM, Karnes JL, Litchy WJ, Klein R, Pach JM, Wilson DM, O'Brien PC, Melton LJ 3rd, Service FJ. The prevalence by staged severity of various types of diabetic neuropathy, retinopathy, and nephropathy in a population-based cohort: the Rochester Diabetic Neuropathy Study. Neurology. 1993 Apr;43(4):817-24. doi: 10.1212/wnl.43.4.817.

  PMID: 8469345 BACKGROUND

• Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. No abstract available.

  PMID: 27999003 BACKGROUND

• Tesfaye S, Chaturvedi N, Eaton SE, Ward JD, Manes C, Ionescu-Tirgoviste C, Witte DR, Fuller JH; EURODIAB Prospective Complications Study Group. Vascular risk factors and diabetic neuropathy. N Engl J Med. 2005 Jan 27;352(4):341-50. doi: 10.1056/NEJMoa032782.

  PMID: 15673800 BACKGROUND

• Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303.

  PMID: 20876709 BACKGROUND

• Daousi C, MacFarlane IA, Woodward A, Nurmikko TJ, Bundred PE, Benbow SJ. Chronic painful peripheral neuropathy in an urban community: a controlled comparison of people with and without diabetes. Diabet Med. 2004 Sep;21(9):976-82. doi: 10.1111/j.1464-5491.2004.01271.x.

  PMID: 15317601 BACKGROUND

• Abbott CA, Malik RA, van Ross ER, Kulkarni J, Boulton AJ. Prevalence and characteristics of painful diabetic neuropathy in a large community-based diabetic population in the U.K. Diabetes Care. 2011 Oct;34(10):2220-4. doi: 10.2337/dc11-1108. Epub 2011 Aug 18.

  PMID: 21852677 BACKGROUND

• Alleman CJ, Westerhout KY, Hensen M, Chambers C, Stoker M, Long S, van Nooten FE. Humanistic and economic burden of painful diabetic peripheral neuropathy in Europe: A review of the literature. Diabetes Res Clin Pract. 2015 Aug;109(2):215-25. doi: 10.1016/j.diabres.2015.04.031. Epub 2015 May 6.

  PMID: 26008721 BACKGROUND

• Binns-Hall O, Selvarajah D, Sanger D, Walker J, Scott A, Tesfaye S. One-stop microvascular screening service: an effective model for the early detection of diabetic peripheral neuropathy and the high-risk foot. Diabet Med. 2018 Jul;35(7):887-894. doi: 10.1111/dme.13630. Epub 2018 May 10.

  PMID: 29608799 BACKGROUND

• Treede RD, Jensen TS, Campbell JN, Cruccu G, Dostrovsky JO, Griffin JW, Hansson P, Hughes R, Nurmikko T, Serra J. Neuropathic pain: redefinition and a grading system for clinical and research purposes. Neurology. 2008 Apr 29;70(18):1630-5. doi: 10.1212/01.wnl.0000282763.29778.59. Epub 2007 Nov 14.

  PMID: 18003941 BACKGROUND

• D'Amato C, Morganti R, Greco C, Di Gennaro F, Cacciotti L, Longo S, Mataluni G, Lauro D, Marfia GA, Spallone V. Diabetic peripheral neuropathic pain is a stronger predictor of depression than other diabetic complications and comorbidities. Diab Vasc Dis Res. 2016 Nov;13(6):418-428. doi: 10.1177/1479164116653240. Epub 2016 Jun 22.

  PMID: 27334483 BACKGROUND

• Ziegler D, Rathmann W, Dickhaus T, Meisinger C, Mielck A; KORA Study Group. Neuropathic pain in diabetes, prediabetes and normal glucose tolerance: the MONICA/KORA Augsburg Surveys S2 and S3. Pain Med. 2009 Mar;10(2):393-400. doi: 10.1111/j.1526-4637.2008.00555.x. Epub 2009 Jan 16.

  PMID: 19207236 BACKGROUND

• Van Acker K, Bouhassira D, De Bacquer D, Weiss S, Matthys K, Raemen H, Mathieu C, Colin IM. Prevalence and impact on quality of life of peripheral neuropathy with or without neuropathic pain in type 1 and type 2 diabetic patients attending hospital outpatients clinics. Diabetes Metab. 2009 Jun;35(3):206-13. doi: 10.1016/j.diabet.2008.11.004. Epub 2009 Mar 17.

  PMID: 19297223 BACKGROUND

• Wu YJ, Lin CC, Yeh CM, Chien ME, Tsao MC, Tseng P, Huang CW, Hsu KS. Repeated transcranial direct current stimulation improves cognitive dysfunction and synaptic plasticity deficit in the prefrontal cortex of streptozotocin-induced diabetic rats. Brain Stimul. 2017 Nov-Dec;10(6):1079-1087. doi: 10.1016/j.brs.2017.08.007. Epub 2017 Aug 24.

  PMID: 28870510 BACKGROUND

• Kim YJ, Ku J, Kim HJ, Im DJ, Lee HS, Han KA, Kang YJ. Randomized, sham controlled trial of transcranial direct current stimulation for painful diabetic polyneuropathy. Ann Rehabil Med. 2013 Dec;37(6):766-76. doi: 10.5535/arm.2013.37.6.766. Epub 2013 Dec 23.

  PMID: 24466511 BACKGROUND

• Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.

  PMID: 27866120 BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies; Chronic Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Slivia Natoli, MD, PhD

  Department of Clinical Science and Translational Medicine, University of Rome Tor Vergata, 00133 Rome, Italy.

  STUDY DIRECTOR

Central Study Contacts

Silvia Natoli, MD, PhD

CONTACT

+393451690925; silvia.natoli@uniroma2.it

Antonio Pisani, MD, PhD

CONTACT

+393204311363; pisani@uniroma2.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: postdoctoral fellowship

Model Details: Crossover Assignment

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 12, 2020
• Study Start: June 1, 2020
• Primary Completion: June 6, 2022
• Study Completion: September 1, 2022
• Last Updated: August 10, 2021

Record last verified: 2021-08

Locations

IT (1)