Paired Acute Invasive/Non-invasive Stimulation (PAINS) study: A phase I/II randomized, sham-controlled crossover trial in chronic neuropathic pain

Background: Dorsal root ganglion (DRG) stimulation, an invasive method of neuromodulation, and transcranial direct current stimulation (tDCS), a non-invasive method of altering cortical excitability, have both proven effective in relieving chronic pain. Objective: We employed a randomized, sham-cont...

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Autores principales:	Tariq Parker, Ashley Raghu, Yongzhi Huang, Martin J. Gillies, James J. FitzGerald, Tipu Aziz, Alexander L. Green
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Dorsal root ganglion stimulation Transcranial direct current stimulation Chronic pain EEG Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571
Acceso en línea:	https://doaj.org/article/391ed23dd76a42f0a9cf87002bcac6a7
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spelling	oai:doaj.org-article:391ed23dd76a42f0a9cf87002bcac6a72021-11-20T05:02:51ZPaired Acute Invasive/Non-invasive Stimulation (PAINS) study: A phase I/II randomized, sham-controlled crossover trial in chronic neuropathic pain1935-861X10.1016/j.brs.2021.10.384https://doaj.org/article/391ed23dd76a42f0a9cf87002bcac6a72021-11-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S1935861X21006306https://doaj.org/toc/1935-861XBackground: Dorsal root ganglion (DRG) stimulation, an invasive method of neuromodulation, and transcranial direct current stimulation (tDCS), a non-invasive method of altering cortical excitability, have both proven effective in relieving chronic pain. Objective: We employed a randomized, sham-controlled crossover study design to investigate whether single-session tDCS would have an additive therapeutic effect alongside DRG stimulation (DRGS) in the treatment of chronic pain. Methods: Sixteen neuropathic pain patients who were previously implanted with DRG stimulators were recruited. Baseline pain scores were established with DRGS-OFF. Pain scores were then recorded with DRGS-ON, after paired sham tDCS stimulation, and after paired active anodal tDCS (a-tDCS) stimulation. For active tDCS, patients were randomized to ‘MEG (magnetoencephalography) localized’ tDCS or contralateral motor cortex (M1) tDCS for 30 min. EEG recordings and evaluations of tDCS adverse effects were also collected. Results: All participants reported the interventions to be tolerable with no significant adverse effects during the session. Paired DRGS/active tDCS resulted in a significant reduction in pain scores compared to paired DRGS-ON/sham tDCS or DRGS alone. There was no difference in the additive effect of M1 vs. MEG-localized tDCS. Significant augmentation of beta activity was observed between DRGS-OFF and DRGS-ON conditions, as well as between paired DRGS-ON/sham tDCS and paired DRGS-ON/active tDCS. Conclusion: Our results indicate that a single session of tDCS alongside DRGS is safe and can significantly reduce pain acutely in neuropathic pain patients. Paired invasive/non-invasive neuromodulation is a promising new treatment strategy for pain management and should be evaluated further to assess long-term benefits.Tariq ParkerAshley RaghuYongzhi HuangMartin J. GilliesJames J. FitzGeraldTipu AzizAlexander L. GreenElsevierarticleDorsal root ganglion stimulationTranscranial direct current stimulationChronic painEEGNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571ENBrain Stimulation, Vol 14, Iss 6, Pp 1576-1585 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Dorsal root ganglion stimulation Transcranial direct current stimulation Chronic pain EEG Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571
spellingShingle	Dorsal root ganglion stimulation Transcranial direct current stimulation Chronic pain EEG Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Tariq Parker Ashley Raghu Yongzhi Huang Martin J. Gillies James J. FitzGerald Tipu Aziz Alexander L. Green Paired Acute Invasive/Non-invasive Stimulation (PAINS) study: A phase I/II randomized, sham-controlled crossover trial in chronic neuropathic pain
description	Background: Dorsal root ganglion (DRG) stimulation, an invasive method of neuromodulation, and transcranial direct current stimulation (tDCS), a non-invasive method of altering cortical excitability, have both proven effective in relieving chronic pain. Objective: We employed a randomized, sham-controlled crossover study design to investigate whether single-session tDCS would have an additive therapeutic effect alongside DRG stimulation (DRGS) in the treatment of chronic pain. Methods: Sixteen neuropathic pain patients who were previously implanted with DRG stimulators were recruited. Baseline pain scores were established with DRGS-OFF. Pain scores were then recorded with DRGS-ON, after paired sham tDCS stimulation, and after paired active anodal tDCS (a-tDCS) stimulation. For active tDCS, patients were randomized to ‘MEG (magnetoencephalography) localized’ tDCS or contralateral motor cortex (M1) tDCS for 30 min. EEG recordings and evaluations of tDCS adverse effects were also collected. Results: All participants reported the interventions to be tolerable with no significant adverse effects during the session. Paired DRGS/active tDCS resulted in a significant reduction in pain scores compared to paired DRGS-ON/sham tDCS or DRGS alone. There was no difference in the additive effect of M1 vs. MEG-localized tDCS. Significant augmentation of beta activity was observed between DRGS-OFF and DRGS-ON conditions, as well as between paired DRGS-ON/sham tDCS and paired DRGS-ON/active tDCS. Conclusion: Our results indicate that a single session of tDCS alongside DRGS is safe and can significantly reduce pain acutely in neuropathic pain patients. Paired invasive/non-invasive neuromodulation is a promising new treatment strategy for pain management and should be evaluated further to assess long-term benefits.
format	article
author	Tariq Parker Ashley Raghu Yongzhi Huang Martin J. Gillies James J. FitzGerald Tipu Aziz Alexander L. Green
author_facet	Tariq Parker Ashley Raghu Yongzhi Huang Martin J. Gillies James J. FitzGerald Tipu Aziz Alexander L. Green
author_sort	Tariq Parker
title	Paired Acute Invasive/Non-invasive Stimulation (PAINS) study: A phase I/II randomized, sham-controlled crossover trial in chronic neuropathic pain
title_short	Paired Acute Invasive/Non-invasive Stimulation (PAINS) study: A phase I/II randomized, sham-controlled crossover trial in chronic neuropathic pain
title_full	Paired Acute Invasive/Non-invasive Stimulation (PAINS) study: A phase I/II randomized, sham-controlled crossover trial in chronic neuropathic pain
title_fullStr	Paired Acute Invasive/Non-invasive Stimulation (PAINS) study: A phase I/II randomized, sham-controlled crossover trial in chronic neuropathic pain
title_full_unstemmed	Paired Acute Invasive/Non-invasive Stimulation (PAINS) study: A phase I/II randomized, sham-controlled crossover trial in chronic neuropathic pain
title_sort	paired acute invasive/non-invasive stimulation (pains) study: a phase i/ii randomized, sham-controlled crossover trial in chronic neuropathic pain
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/391ed23dd76a42f0a9cf87002bcac6a7
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Paired Acute Invasive/Non-invasive Stimulation (PAINS) study: A phase I/II randomized, sham-controlled crossover trial in chronic neuropathic pain

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