Using High-Definition Transcranial Alternating Current Stimulation to Treat Patients with Fibromyalgia: A Randomized Double-Blinded Controlled Study
Objectives: This study aimed to investigate the safety and efficacy of high-definition transcranial alternating current stimulation (HD-tACS) to the left primary motor cortex (M1) in the treatment of fibromyalgia (FM) patients. Methods: In this randomized, double-blind, sham-controlled clinical tria...
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MDPI AG
2022-08-01
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Online Access: | https://www.mdpi.com/2075-1729/12/9/1364 |
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author | Ashleigh Peng Lin Chun-Chieh Chiu Shih-Ching Chen Yi-Jing Huang Chien-Hung Lai Jiunn-Horng Kang |
author_facet | Ashleigh Peng Lin Chun-Chieh Chiu Shih-Ching Chen Yi-Jing Huang Chien-Hung Lai Jiunn-Horng Kang |
author_sort | Ashleigh Peng Lin |
collection | DOAJ |
description | Objectives: This study aimed to investigate the safety and efficacy of high-definition transcranial alternating current stimulation (HD-tACS) to the left primary motor cortex (M1) in the treatment of fibromyalgia (FM) patients. Methods: In this randomized, double-blind, sham-controlled clinical trial, patients with FM were recruited in a teaching hospital. Thirty-eight patients were randomized to active HD-tACS (<i>n</i> = 19) or sham stimulation (<i>n</i> = 19). Active stimulation included a daily session of 20-min stimulation of 1 mA HD-tACS over the left M1 for ten sessions in two weeks. The primary outcome was the change in pain intensity and quality of life, assessed using the numeric rating scale (NRS) and the fibromyalgia impact questionnaire (FIQ) at baseline and after two weeks of treatment. Secondary outcomes included other core symptoms of FM (psychological distress, sleep quality, hyperalgesia measured by pressure pain threshold) and changes in biomarkers’ total Tau and Aβ1-42. All analyses were based on intention-to-treat for a significance level of <i>p</i> < 0.05. Results: Of the 38 randomized patients, 35 completed the study. After two weeks, HD-tACS induced a significant reduction in FIQ score post-treatment. However, there were no significant differences in NRS and FIQ scores compared to sham stimulation. Most adverse events were mild in severity. Nevertheless, one patient receiving HD-tACS attempted suicide during the trial. Conclusions: These results suggest that HD-tACS may effectively reduce pain, psychological distress, and symptom impacts in FM patients. However, we found no significant differences between the two groups. Future studies investigating HD-tACS in FM are warranted. |
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language | English |
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spelling | doaj.art-d701765b3d1b446eb37014fc08058bdd2023-11-23T17:22:51ZengMDPI AGLife2075-17292022-08-01129136410.3390/life12091364Using High-Definition Transcranial Alternating Current Stimulation to Treat Patients with Fibromyalgia: A Randomized Double-Blinded Controlled StudyAshleigh Peng Lin0Chun-Chieh Chiu1Shih-Ching Chen2Yi-Jing Huang3Chien-Hung Lai4Jiunn-Horng Kang5Department of Physical Medicine and Rehabilitation, Taipei Medical University Hospital, Taipei 110, TaiwanDepartment of Physical Medicine and Rehabilitation, School of Medicine, College of Medicine, Taipei Medical University, Taipei 110, TaiwanDepartment of Physical Medicine and Rehabilitation, Taipei Medical University Hospital, Taipei 110, TaiwanSchool of Occupational Therapy, College of Medicine, National Taiwan University, Taipei 10051, TaiwanDepartment of Physical Medicine and Rehabilitation, Taipei Medical University Hospital, Taipei 110, TaiwanDepartment of Physical Medicine and Rehabilitation, Taipei Medical University Hospital, Taipei 110, TaiwanObjectives: This study aimed to investigate the safety and efficacy of high-definition transcranial alternating current stimulation (HD-tACS) to the left primary motor cortex (M1) in the treatment of fibromyalgia (FM) patients. Methods: In this randomized, double-blind, sham-controlled clinical trial, patients with FM were recruited in a teaching hospital. Thirty-eight patients were randomized to active HD-tACS (<i>n</i> = 19) or sham stimulation (<i>n</i> = 19). Active stimulation included a daily session of 20-min stimulation of 1 mA HD-tACS over the left M1 for ten sessions in two weeks. The primary outcome was the change in pain intensity and quality of life, assessed using the numeric rating scale (NRS) and the fibromyalgia impact questionnaire (FIQ) at baseline and after two weeks of treatment. Secondary outcomes included other core symptoms of FM (psychological distress, sleep quality, hyperalgesia measured by pressure pain threshold) and changes in biomarkers’ total Tau and Aβ1-42. All analyses were based on intention-to-treat for a significance level of <i>p</i> < 0.05. Results: Of the 38 randomized patients, 35 completed the study. After two weeks, HD-tACS induced a significant reduction in FIQ score post-treatment. However, there were no significant differences in NRS and FIQ scores compared to sham stimulation. Most adverse events were mild in severity. Nevertheless, one patient receiving HD-tACS attempted suicide during the trial. Conclusions: These results suggest that HD-tACS may effectively reduce pain, psychological distress, and symptom impacts in FM patients. However, we found no significant differences between the two groups. Future studies investigating HD-tACS in FM are warranted.https://www.mdpi.com/2075-1729/12/9/1364fibromyalgianeuromodulationtranscranial stimulationpainquality of lifehigh-definition |
spellingShingle | Ashleigh Peng Lin Chun-Chieh Chiu Shih-Ching Chen Yi-Jing Huang Chien-Hung Lai Jiunn-Horng Kang Using High-Definition Transcranial Alternating Current Stimulation to Treat Patients with Fibromyalgia: A Randomized Double-Blinded Controlled Study Life fibromyalgia neuromodulation transcranial stimulation pain quality of life high-definition |
title | Using High-Definition Transcranial Alternating Current Stimulation to Treat Patients with Fibromyalgia: A Randomized Double-Blinded Controlled Study |
title_full | Using High-Definition Transcranial Alternating Current Stimulation to Treat Patients with Fibromyalgia: A Randomized Double-Blinded Controlled Study |
title_fullStr | Using High-Definition Transcranial Alternating Current Stimulation to Treat Patients with Fibromyalgia: A Randomized Double-Blinded Controlled Study |
title_full_unstemmed | Using High-Definition Transcranial Alternating Current Stimulation to Treat Patients with Fibromyalgia: A Randomized Double-Blinded Controlled Study |
title_short | Using High-Definition Transcranial Alternating Current Stimulation to Treat Patients with Fibromyalgia: A Randomized Double-Blinded Controlled Study |
title_sort | using high definition transcranial alternating current stimulation to treat patients with fibromyalgia a randomized double blinded controlled study |
topic | fibromyalgia neuromodulation transcranial stimulation pain quality of life high-definition |
url | https://www.mdpi.com/2075-1729/12/9/1364 |
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