Safety and Feasibility of Transcranial Direct Current Stimulation for Cognitive Rehabilitation in Patients With Mild or Major Neurocognitive Disorders: A Randomized Sham-Controlled Pilot Study
IntroductionTranscranial direct current stimulation (tDCS) is a potentially novel strategy for cognitive enhancement in patients with mild or major neurocognitive disorders. This study aims to assess the safety and efficacy of tDCS during cognitive training on cognitive functioning in patients with...
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Frontiers Media S.A.
2019-09-01
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| Series: | Frontiers in Human Neuroscience |
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| Online Access: | https://www.frontiersin.org/article/10.3389/fnhum.2019.00273/full |
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| author | Takuma Inagawa Yuma Yokoi Zui Narita Kazushi Maruo Mitsutoshi Okazaki Kazuyuki Nakagome |
| author_facet | Takuma Inagawa Yuma Yokoi Zui Narita Kazushi Maruo Mitsutoshi Okazaki Kazuyuki Nakagome |
| author_sort | Takuma Inagawa |
| collection | DOAJ |
| description | IntroductionTranscranial direct current stimulation (tDCS) is a potentially novel strategy for cognitive enhancement in patients with mild or major neurocognitive disorders. This study aims to assess the safety and efficacy of tDCS during cognitive training on cognitive functioning in patients with mild or major neurocognitive disorders.MethodsThis study was primarily a single arm for safety, secondary a two-arm, parallel, randomized, and sham-controlled trial for potential efficacy. Patients with mild or major neurocognitive disorders were recruited. The participants and raters were blinded to the group assignment. The participants in the active arm received tDCS (anodal; F3, cathodal, Fp2, 2A, 20 min) twice daily for five consecutive days, whereas those in the sham arm received the same amount of sham-tDCS. Calculation and reading tasks were conducted in both arms as a form of cognitive intervention for 20 min during tDCS. The primary outcome was the attrition rate during the trial in the active arm, which is expected to be less than 10%. The secondary outcomes were the between-group differences of adjusted means for several cognitive scales from baseline to post-intervention and follow-up.ResultsTwenty patients [nine women (45%)], with a mean (standard deviation) age of 76.1 years participated; nine patients (45%) with minor neurocognitive disorders and 11 (55%) with major neurocognitive disorders were randomized, and 19 of them completed the trial. The attrition rate in the active arm was 0%, with no serious adverse events. Further, in the Intention-to-Treat analysis, patients in the active arm showed no statistically significant improvement compared with those who received the sham in the mean change scores of the mini-mental state examination [0.41; 95% CI (−1.85; 2.67) at day five, 1.08; 95% CI (−1.31; 3.46) at follow-up] and Alzheimer’s disease assessment scale – cognition subscale [1.61; 95% CI (−4.2; 0.98) at day 5, 0.36; 95%CI (−3.19; 2.47) at follow-up].ConclusionThese findings suggest that tDCS is safe and tolerable but causes no statistically significant cognitive effects in patients with mild or major neurocognitive disorders. Additional large-scale, well-designed clinical trials are warranted to evaluate the cognitive effects of tDCS as an augmentation to cognitive training.Clinical Trial Registrationwww.ClinicalTrials.gov, identifier NCT03050385. |
| first_indexed | 2024-12-23T10:46:33Z |
| format | Article |
| id | doaj.art-c6e05eaea8b646739a673f95a86fcd0e |
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| issn | 1662-5161 |
| language | English |
| last_indexed | 2024-12-23T10:46:33Z |
| publishDate | 2019-09-01 |
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| spelling | doaj.art-c6e05eaea8b646739a673f95a86fcd0e2022-12-21T17:50:01ZengFrontiers Media S.A.Frontiers in Human Neuroscience1662-51612019-09-011310.3389/fnhum.2019.00273438905Safety and Feasibility of Transcranial Direct Current Stimulation for Cognitive Rehabilitation in Patients With Mild or Major Neurocognitive Disorders: A Randomized Sham-Controlled Pilot StudyTakuma Inagawa0Yuma Yokoi1Zui Narita2Kazushi Maruo3Mitsutoshi Okazaki4Kazuyuki Nakagome5Department of Psychiatry, National Center of Neurology and Psychiatry, National Center Hospital, Kodaira, JapanDepartment of Psychiatry, National Center of Neurology and Psychiatry, National Center Hospital, Kodaira, JapanDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, United StatesFaculty of Medicine, University of Tsukuba, Tsukuba, JapanDepartment of Psychiatry, National Center of Neurology and Psychiatry, National Center Hospital, Kodaira, JapanDepartment of Psychiatry, National Center of Neurology and Psychiatry, National Center Hospital, Kodaira, JapanIntroductionTranscranial direct current stimulation (tDCS) is a potentially novel strategy for cognitive enhancement in patients with mild or major neurocognitive disorders. This study aims to assess the safety and efficacy of tDCS during cognitive training on cognitive functioning in patients with mild or major neurocognitive disorders.MethodsThis study was primarily a single arm for safety, secondary a two-arm, parallel, randomized, and sham-controlled trial for potential efficacy. Patients with mild or major neurocognitive disorders were recruited. The participants and raters were blinded to the group assignment. The participants in the active arm received tDCS (anodal; F3, cathodal, Fp2, 2A, 20 min) twice daily for five consecutive days, whereas those in the sham arm received the same amount of sham-tDCS. Calculation and reading tasks were conducted in both arms as a form of cognitive intervention for 20 min during tDCS. The primary outcome was the attrition rate during the trial in the active arm, which is expected to be less than 10%. The secondary outcomes were the between-group differences of adjusted means for several cognitive scales from baseline to post-intervention and follow-up.ResultsTwenty patients [nine women (45%)], with a mean (standard deviation) age of 76.1 years participated; nine patients (45%) with minor neurocognitive disorders and 11 (55%) with major neurocognitive disorders were randomized, and 19 of them completed the trial. The attrition rate in the active arm was 0%, with no serious adverse events. Further, in the Intention-to-Treat analysis, patients in the active arm showed no statistically significant improvement compared with those who received the sham in the mean change scores of the mini-mental state examination [0.41; 95% CI (−1.85; 2.67) at day five, 1.08; 95% CI (−1.31; 3.46) at follow-up] and Alzheimer’s disease assessment scale – cognition subscale [1.61; 95% CI (−4.2; 0.98) at day 5, 0.36; 95%CI (−3.19; 2.47) at follow-up].ConclusionThese findings suggest that tDCS is safe and tolerable but causes no statistically significant cognitive effects in patients with mild or major neurocognitive disorders. Additional large-scale, well-designed clinical trials are warranted to evaluate the cognitive effects of tDCS as an augmentation to cognitive training.Clinical Trial Registrationwww.ClinicalTrials.gov, identifier NCT03050385.https://www.frontiersin.org/article/10.3389/fnhum.2019.00273/fulltranscranial direct current stimulationcognitive trainingneurocognitive disorderdementiamild cognitive impairment |
| spellingShingle | Takuma Inagawa Yuma Yokoi Zui Narita Kazushi Maruo Mitsutoshi Okazaki Kazuyuki Nakagome Safety and Feasibility of Transcranial Direct Current Stimulation for Cognitive Rehabilitation in Patients With Mild or Major Neurocognitive Disorders: A Randomized Sham-Controlled Pilot Study Frontiers in Human Neuroscience transcranial direct current stimulation cognitive training neurocognitive disorder dementia mild cognitive impairment |
| title | Safety and Feasibility of Transcranial Direct Current Stimulation for Cognitive Rehabilitation in Patients With Mild or Major Neurocognitive Disorders: A Randomized Sham-Controlled Pilot Study |
| title_full | Safety and Feasibility of Transcranial Direct Current Stimulation for Cognitive Rehabilitation in Patients With Mild or Major Neurocognitive Disorders: A Randomized Sham-Controlled Pilot Study |
| title_fullStr | Safety and Feasibility of Transcranial Direct Current Stimulation for Cognitive Rehabilitation in Patients With Mild or Major Neurocognitive Disorders: A Randomized Sham-Controlled Pilot Study |
| title_full_unstemmed | Safety and Feasibility of Transcranial Direct Current Stimulation for Cognitive Rehabilitation in Patients With Mild or Major Neurocognitive Disorders: A Randomized Sham-Controlled Pilot Study |
| title_short | Safety and Feasibility of Transcranial Direct Current Stimulation for Cognitive Rehabilitation in Patients With Mild or Major Neurocognitive Disorders: A Randomized Sham-Controlled Pilot Study |
| title_sort | safety and feasibility of transcranial direct current stimulation for cognitive rehabilitation in patients with mild or major neurocognitive disorders a randomized sham controlled pilot study |
| topic | transcranial direct current stimulation cognitive training neurocognitive disorder dementia mild cognitive impairment |
| url | https://www.frontiersin.org/article/10.3389/fnhum.2019.00273/full |
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