tDCS Associated With Peripheral Electrical Stimulation for Pain Control in Individuals With Sickle Cell Disease
tDCS/PES_SCD
Transcranial Direct Current Stimulation Associated With Peripheral Electrical Stimulation for Pain Control in Individuals With Sickle Cell Disease
1 other identifier
interventional
120
1 country
1
Brief Summary
So far, no study investigated the safety and efficacy analgesic of transcranial direct current stimulation (tDCS) associated to peripheral electrical stimulation (PES) in individuals with SCD who suffer from chronic pain. Several studies have reported a decrease in O²Hb concentration in the regions below the electrodes and in other cortical areas during anodic or cathodic tDCS, which implies a risk factor for vasoocclusive events in individuals with SDC due to polymerization of hemoglobin when exposed to these low O²Hb concentrations. For this reasion, the aim main of this study is to assess the effect of a single session of transcranial direct current stimulation (tDCS) associated to peripheral electrical stimulation (PES) on safety and efficacy analgesic in individuals with sickle cell disease (SCD). Others aims sencondaries are evaluate the effect of a single session of transcranial direct current stimulation (tDCS) associated to peripheral electrical stimulation (PES) on biomarkers neurophysiological and inflammatory.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2016
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 10, 2016
CompletedFirst Posted
Study publicly available on registry
June 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedSeptember 24, 2018
September 1, 2018
6.8 years
May 10, 2016
September 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in pain intensity
Pain assessment at before and after each intervention: Actual pain intensity will be assessed using a 0-10 visual analogue scale (VAS), where 0 is no pain and 10 the worst imaginable pain. Visual analogue scale allows to evaluate the intensity pain of a quantitative way, the subjects will fill a VAS before and after treatment.
One day
Secondary Outcomes (5)
Analysis of brain waves delta, theta, alpha and beta
One day
Dosages of TNF-alpha and BDNF in patients with SCD
One day
Motor cortical reorganization
One day
Impact of pain in functionality
One day
Hospital anxiety and depression scale (HADS)
One day
Study Arms (8)
SS-tDCS (active) plus PES (active)
ACTIVE COMPARATORtDCS plus PES (n=15).
SS-tDCS (active) plus PES (simulated)
ACTIVE COMPARATORtDCS plus PES (n=15).
SS-tDCS (simulated) plus PES (active)
ACTIVE COMPARATORtDCS plus PES (n=15).
SS-tDCS (simulated) plus PES (simulated)
SHAM COMPARATORtDCS plus PES (n=15).
SC-tDCS (active) plus PES (active)
ACTIVE COMPARATORtDCS plus PES (n=15).
SC-tDCS (active) plus PES (simulated)
ACTIVE COMPARATORtDCS plus PES (n=15).
SC-tDCS (simulated) plus PES (active)
ACTIVE COMPARATORtDCS plus PES (n=15).
SC-tDCS (simulated) plus PES (simulated)
SHAM COMPARATORtDCS plus PES (n=15).
Interventions
transcranial direct current stimulation (tDCS) uses a pair of electrodes and sponges soaked in saline solution placed over specific regions of the head to polarize neurons and produce changes in resting membrane potentials. This changes may increase or decrease neuronal excitability and produce diverse clinical effects, including analgesia. PES uses also a pair of electrodes over specific regions of the body to promote neuronal action potentials in peripheral nerves. PES over motor threshold increases cortical excitability, and at the sensory threshold decreases excitability.
Eligibility Criteria
You may qualify if:
- Being diagnosed with sickle cell disease hemoglobin electrophoresis.
- Be aged 18 years old to 50 years old.
- Having signed the consent form and clarified.
- Having chronic pain with at least 3 months duration.
- Being diagnosed with femoral head osteonecrosis
- Have more than one type of chronic pain.
You may not qualify if:
- Have cochlear implants, pacemakers or metallic implant in the skull / brain;
- Have metallic implant application site of peripheral stimulation;
- History of head trauma;
- Pregnancy;
- seizures or epilepsy History;
- Being in drug use that modify neuronal activation threshold (eg antidepressants and anticonvulsants);
- Having diagnosis of fibromyalgia, or any impairment to be confused with the symptoms of SCD;
- Have pain confirmed neuropathic type.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Faculdade Adventista da Bahialead
- Federal University of Bahiacollaborator
Study Sites (1)
Functional Electrical Stimulation Laboratory
Salvador, Estado de Bahia, 40110-902, Brazil
Related Publications (20)
Yusuf HR, Atrash HK, Grosse SD, Parker CS, Grant AM. Emergency department visits made by patients with sickle cell disease: a descriptive study, 1999-2007. Am J Prev Med. 2010 Apr;38(4 Suppl):S536-41. doi: 10.1016/j.amepre.2010.01.001.
PMID: 20331955BACKGROUNDBallas SK. Pain management of sickle cell disease. Hematol Oncol Clin North Am. 2005 Oct;19(5):785-802, v. doi: 10.1016/j.hoc.2005.07.008.
PMID: 16214644BACKGROUNDLima MC, Riberto M, Batistella LR, Boggio PS, Fregni F. Estimulação cerebral para o tratamento de dor neuropática. Psicol. teor. prát. 2007; 9(2):142-149
BACKGROUNDOliveira LB, Lopes TS, Soares C, Maluf R, Goes BT, Sa KN, Baptista AF. Transcranial direct current stimulation and exercises for treatment of chronic temporomandibular disorders: a blind randomised-controlled trial. J Oral Rehabil. 2015 Oct;42(10):723-32. doi: 10.1111/joor.12300. Epub 2015 Apr 20.
PMID: 25891021BACKGROUNDBrunoni AR, Pinheiro FS, Boggio PS. Estimulação transcraniana por corrente contínua: in Fregni F, Boggio PS, Brunoni AR. Neuromodulação Terapêutica: Princípios e Avanços da Estimulação cerebral não invasiva em Neurologia, reabilitação, Psiquiatria e Neuropsicologia. São Paulo: Sarvier. 2012: 65-75.
BACKGROUNDBoggio PS, Amancio EJ, Correa CF, Cecilio S, Valasek C, Bajwa Z, Freedman SD, Pascual-Leone A, Edwards DJ, Fregni F. Transcranial DC stimulation coupled with TENS for the treatment of chronic pain: a preliminary study. Clin J Pain. 2009 Oct;25(8):691-5. doi: 10.1097/AJP.0b013e3181af1414.
PMID: 19920718BACKGROUNDSchabrun SM, Jones E, Elgueta Cancino EL, Hodges PW. Targeting chronic recurrent low back pain from the top-down and the bottom-up: a combined transcranial direct current stimulation and peripheral electrical stimulation intervention. Brain Stimul. 2014 May-Jun;7(3):451-9. doi: 10.1016/j.brs.2014.01.058. Epub 2014 Jan 30.
PMID: 24582372BACKGROUNDHazime FA, de Freitas DG, Monteiro RL, Maretto RL, Carvalho NA, Hasue RH, Joao SM. Analgesic efficacy of cerebral and peripheral electrical stimulation in chronic nonspecific low back pain: a randomized, double-blind, factorial clinical trial. BMC Musculoskelet Disord. 2015 Jan 31;16(1):7. doi: 10.1186/s12891-015-0461-1.
PMID: 25636503BACKGROUNDVuckovic A, Hasan MA, Fraser M, Conway BA, Nasseroleslami B, Allan DB. Dynamic oscillatory signatures of central neuropathic pain in spinal cord injury. J Pain. 2014 Jun;15(6):645-55. doi: 10.1016/j.jpain.2014.02.005. Epub 2014 Mar 1.
PMID: 24589821BACKGROUNDde Vries M, Wilder-Smith OH, Jongsma ML, van den Broeke EN, Arns M, van Goor H, van Rijn CM. Altered resting state EEG in chronic pancreatitis patients: toward a marker for chronic pain. J Pain Res. 2013 Nov 25;6:815-24. doi: 10.2147/JPR.S50919.
PMID: 24379694BACKGROUNDSarnthein J, Stern J, Aufenberg C, Rousson V, Jeanmonod D. Increased EEG power and slowed dominant frequency in patients with neurogenic pain. Brain. 2006 Jan;129(Pt 1):55-64. doi: 10.1093/brain/awh631. Epub 2005 Sep 23.
PMID: 16183660BACKGROUNDApkarian AV, Bushnell MC, Treede RD, Zubieta JK. Human brain mechanisms of pain perception and regulation in health and disease. Eur J Pain. 2005 Aug;9(4):463-84. doi: 10.1016/j.ejpain.2004.11.001. Epub 2005 Jan 21.
PMID: 15979027BACKGROUNDMichels L, Moazami-Goudarzi M, Jeanmonod D. Correlations between EEG and clinical outcome in chronic neuropathic pain: surgical effects and treatment resistance. Brain Imaging Behav. 2011 Dec;5(4):329-48. doi: 10.1007/s11682-011-9135-2.
PMID: 21948245BACKGROUNDBoord P, Siddall PJ, Tran Y, Herbert D, Middleton J, Craig A. Electroencephalographic slowing and reduced reactivity in neuropathic pain following spinal cord injury. Spinal Cord. 2008 Feb;46(2):118-23. doi: 10.1038/sj.sc.3102077. Epub 2007 May 15.
PMID: 17502876BACKGROUNDLlinas RR, Ribary U, Jeanmonod D, Kronberg E, Mitra PP. Thalamocortical dysrhythmia: A neurological and neuropsychiatric syndrome characterized by magnetoencephalography. Proc Natl Acad Sci U S A. 1999 Dec 21;96(26):15222-7. doi: 10.1073/pnas.96.26.15222.
PMID: 10611366BACKGROUNDGoncalves MS, Queiroz IL, Cardoso SA, Zanetti A, Strapazoni AC, Adorno E, Albuquerque A, Sant'Ana A, dos Reis MG, Barral A, Barral Netto M. Interleukin 8 as a vaso-occlusive marker in Brazilian patients with sickle cell disease. Braz J Med Biol Res. 2001 Oct;34(10):1309-13. doi: 10.1590/s0100-879x2001001000011.
PMID: 11593306BACKGROUNDHajeer AH, Hutchinson IV. Influence of TNFalpha gene polymorphisms on TNFalpha production and disease. Hum Immunol. 2001 Nov;62(11):1191-9. doi: 10.1016/s0198-8859(01)00322-6.
PMID: 11704281BACKGROUNDLouis E, Franchimont D, Piron A, Gevaert Y, Schaaf-Lafontaine N, Roland S, Mahieu P, Malaise M, De Groote D, Louis R, Belaiche J. Tumour necrosis factor (TNF) gene polymorphism influences TNF-alpha production in lipopolysaccharide (LPS)-stimulated whole blood cell culture in healthy humans. Clin Exp Immunol. 1998 Sep;113(3):401-6. doi: 10.1046/j.1365-2249.1998.00662.x.
PMID: 9737669BACKGROUNDMoalem G, Tracey DJ. Immune and inflammatory mechanisms in neuropathic pain. Brain Res Rev. 2006 Aug;51(2):240-64. doi: 10.1016/j.brainresrev.2005.11.004. Epub 2006 Jan 4.
PMID: 16388853BACKGROUNDChaieb L, Antal A, Ambrus GG, Paulus W. Brain-derived neurotrophic factor: its impact upon neuroplasticity and neuroplasticity inducing transcranial brain stimulation protocols. Neurogenetics. 2014 Mar;15(1):1-11. doi: 10.1007/s10048-014-0393-1. Epub 2014 Feb 25.
PMID: 24567226BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abrahão F Baptista, Prof.
Federal University of Bahia
- STUDY DIRECTOR
Wellington S Silva, Prof.
Faculdade Adventista da Bahia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2016
First Posted
June 27, 2016
Study Start
March 1, 2016
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
September 24, 2018
Record last verified: 2018-09