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...
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2021-11-01
|
| Series: | Brain Stimulation |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1935861X21006306 |
| _version_ | 1819000942685585408 |
|---|---|
| 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 |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-12-20T22:41:20Z |
| format | Article |
| id | doaj.art-391ed23dd76a42f0a9cf87002bcac6a7 |
| institution | Directory Open Access Journal |
| issn | 1935-861X |
| language | English |
| last_indexed | 2024-12-20T22:41:20Z |
| publishDate | 2021-11-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Brain Stimulation |
| spelling | doaj.art-391ed23dd76a42f0a9cf87002bcac6a72022-12-21T19:24:28ZengElsevierBrain Stimulation1935-861X2021-11-0114615761585Paired Acute Invasive/Non-invasive Stimulation (PAINS) study: A phase I/II randomized, sham-controlled crossover trial in chronic neuropathic painTariq Parker0Ashley Raghu1Yongzhi Huang2Martin J. Gillies3James J. FitzGerald4Tipu Aziz5Alexander L. Green6Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom; Neurosurgery Department, Massachusetts General Hospital, Boston, MA, USA; Corresponding author. Department of Neurosurgery, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, USA.Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United KingdomNuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom; Academy of Medical Engineering and Translational Medicine, Tianjin University, Tianjin, 300072, ChinaNuffield Department of Surgical Sciences, University of Oxford, Oxford, United KingdomNuffield Department of Surgical Sciences, University of Oxford, Oxford, United KingdomNuffield Department of Surgical Sciences, University of Oxford, Oxford, United KingdomNuffield Department of Surgical Sciences, University of Oxford, Oxford, United KingdomBackground: 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.http://www.sciencedirect.com/science/article/pii/S1935861X21006306Dorsal root ganglion stimulationTranscranial direct current stimulationChronic painEEG |
| spellingShingle | 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 Brain Stimulation Dorsal root ganglion stimulation Transcranial direct current stimulation Chronic pain EEG |
| title | 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_short | 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 |
| topic | Dorsal root ganglion stimulation Transcranial direct current stimulation Chronic pain EEG |
| url | http://www.sciencedirect.com/science/article/pii/S1935861X21006306 |
| work_keys_str_mv | AT tariqparker pairedacuteinvasivenoninvasivestimulationpainsstudyaphaseiiirandomizedshamcontrolledcrossovertrialinchronicneuropathicpain AT ashleyraghu pairedacuteinvasivenoninvasivestimulationpainsstudyaphaseiiirandomizedshamcontrolledcrossovertrialinchronicneuropathicpain AT yongzhihuang pairedacuteinvasivenoninvasivestimulationpainsstudyaphaseiiirandomizedshamcontrolledcrossovertrialinchronicneuropathicpain AT martinjgillies pairedacuteinvasivenoninvasivestimulationpainsstudyaphaseiiirandomizedshamcontrolledcrossovertrialinchronicneuropathicpain AT jamesjfitzgerald pairedacuteinvasivenoninvasivestimulationpainsstudyaphaseiiirandomizedshamcontrolledcrossovertrialinchronicneuropathicpain AT tipuaziz pairedacuteinvasivenoninvasivestimulationpainsstudyaphaseiiirandomizedshamcontrolledcrossovertrialinchronicneuropathicpain AT alexanderlgreen pairedacuteinvasivenoninvasivestimulationpainsstudyaphaseiiirandomizedshamcontrolledcrossovertrialinchronicneuropathicpain |