tDCS Associated With Peripheral Electrical Stimulation for Pain Control in Individuals With Sickle Cell Disease
NCT ID: NCT02813629
Last Updated: 2018-09-24
Study Results
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Basic Information
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UNKNOWN
PHASE2
120 participants
INTERVENTIONAL
2016-03-31
2022-12-31
Brief Summary
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Detailed Description
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The tDCS has the potential to change the neuronal membrane resting potential, this effect is dependent on the polarity, being that cathode produces hyperpolarization, whereas anode produces depolarization, in this way can induce an effect of inhibition and facilitation of neuronal firing, respectively. This effects can induces changes in cortical excitability. Although tDCS may modulate areas related to endogenous pain control, its effects seem to be diffuse, and focality would probably enhance its effects. The peripheral electrical stimulation (PES), in another way, may also modulate cortical excitability, depending mainly on its amplitude and frequency. PES modulation of cortical excitability is very focal, occurring only in the stimulated region. The combination of these two neuromodulatory techniques has showed additive effects in some studies with individuals suffering from chronic pain,which promoting a general effect (tDCS), and the other a more focal effect (TENS). Although this additive effect has been demonstrated, to date, no study evaluate its safety and efficacy in individuals with DF.
As a secondary outcome, the investigators are going to access the influence of the intervention on quantitative electroencephalography (qEEG). Growing evidence points out to different brain characteristics between individuals with chronic pain and healthy. qEEG has high temporal resolution and evaluates primary electrical effects of neural excitation, allowing identify possible patterns of brain functioning in individuals with chronic pain. qEEG allowed the identification of the thalamocortical dysrhythmia (TCD) in patients with chronic pain characterized by an increased low frequency band power density theta (4 - 7Hz) and a decrease in high frequency bands alpha (8 -12Hz) and beta (13 - 30Hz). This dysrhythmic mechanism may occur from the periphery to the thalamus (bottom-up) or cortical dysregulation (top-down), disinhibition of the thalamus. This process results in hyperpolarization of thalamic neurons, leading to a preponderance of low frequency oscillations in qEEG. The persistence thalamic firing at low frequencies can lead to a collateral inhibition in cortical regions around, which could theoretically lead to a decrease in the higher frequencies. This increase occurs at low frequency regions involved in neuro matrix of pain.
The investigators will alse avaluate the influence of the chronic pain sencondary to avascular necrosis of hip joint about cortical motor reorganization using transcranial magnetic stimuation (TMS). Recent data point to a gluteus maximus muscle weakness during maximal voluntary contraction in pronation position in individuals with joint pain in the hip. Similarly, individuals with legg calve perthes who suffer from femoral head necrosis, weakness of the abductor hip musculature was related to poor clinical outcomes. A possible explanation for these findings is cortical motor reorganization, which is associated with motor control impairment, and this has been demonstrated in individuals with chronic lateral epicondylalgia and knee osteoarthritis, where cortical organization is altered and correlated positively with the time of Pain and is associated with the perpetuation of pain. This cortical reorganization can occur in the somatotopic areas corresponding to the motor or sensorial homunculus, having as characteristic an overlap, retraction and "blurring" in the somatotopic representation of a certain region.
The mediators released by cells of the immune and inflammatory system can act directly on neurons sensitizing and enabling them (usually peripheral nociceptors or neurons in the dorsal horn of the spinal cord). There are several mediators in a long and growing list that includes cytokines and neurotrophins.The major cytokines in an acute inflammation are the Tumor Necrosis Factor (TNF) and the interleukins (IL-1), IL-6 and IL-8, which are important mediators of acute and chronic inflammatory reactions, as well as processes of repair and resolution. High serum levels of IL-8 have been observed in patients in vase-occlusive crisis, important clinical aspect of the pathogenesis of SCD. The presence of the mutant allele A appears to influence the expression of the TNF-alpha, being the AA genotype considered a high producer.
Neurotrophins are dimeric proteins that are essential for the normal development of the nervous system in vertebrates. This family includes the nerve growth factor (NGF), brain-derived neurotrophic factor (BDNF) and other neurotrophins (NT). Currently, it is recognized that certain neurotrophins, particularly the NGF and the brain-derived neurotrophic factor BDNF play a significant role in nociception, so that the NGF sensitizes nociceptors at the periphery, while the BDNF enhances the response ability of the dorsal horn neurons of the spinal cord. The BDNF gene, which encodes the BDNF protein, located on chromosome 11 at the boundary of regions 11p13 and 11p14 of the human genome has been investigated in a wide range of areas related to neuroplasticity, including differences in brain morphology, learning and memory, interactions with brain stimulation protocols of plasticity induction and recovery after brain injury and has been associated with a wide variety of neurological disorders, including, for example, depression, schizophrenia and attention deficit hyperactivity disorder (ADHD).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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SS-tDCS (active) plus PES (active)
tDCS plus PES (n=15).
tDCS plus PES
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.
SS-tDCS (active) plus PES (simulated)
tDCS plus PES (n=15).
tDCS plus PES
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.
SS-tDCS (simulated) plus PES (active)
tDCS plus PES (n=15).
tDCS plus PES
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.
SS-tDCS (simulated) plus PES (simulated)
tDCS plus PES (n=15).
tDCS plus PES
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.
SC-tDCS (active) plus PES (active)
tDCS plus PES (n=15).
tDCS plus PES
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.
SC-tDCS (active) plus PES (simulated)
tDCS plus PES (n=15).
tDCS plus PES
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.
SC-tDCS (simulated) plus PES (active)
tDCS plus PES (n=15).
tDCS plus PES
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.
SC-tDCS (simulated) plus PES (simulated)
tDCS plus PES (n=15).
tDCS plus PES
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.
Interventions
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tDCS plus PES
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
50 Years
ALL
Yes
Sponsors
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Federal University of Bahia
OTHER
Faculdade Adventista da Bahia
OTHER
Responsible Party
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Principal Investigators
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Abrahão F Baptista, Prof.
Role: PRINCIPAL_INVESTIGATOR
Federal University of Bahia
Wellington S Silva, Prof.
Role: STUDY_DIRECTOR
Faculdade Adventista da Bahia
Locations
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Functional Electrical Stimulation Laboratory
Salvador, Estado de Bahia, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Ballas 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.
Lima 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
Oliveira 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.
Brunoni 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.
Boggio 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.
Schabrun 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.
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Apkarian 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.
Michels 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.
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Llinas 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.
Goncalves 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.
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Louis 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.
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Chaieb 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.
Other Identifiers
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31237514.1.0000.0042
Identifier Type: -
Identifier Source: org_study_id
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