Safety and feasibility of optimized transcranial direct current stimulation in patients with mild cognitive impairment due to Alzheimer's disease: a multicenter study protocol for a randomized controlled trial

TaeYeong Kim; Dong Woo Kang; Jhosedyn Carolaym Salazar Fajardo; Hanna Jang; Yoo Hyun Um; Sunghwan Kim; Sheng-Min Wang; Donghyeon Kim; Hyun Kook Lim

doi:10.3389/fneur.2024.1356073

Safety and feasibility of optimized transcranial direct current stimulation in patients with mild cognitive impairment due to Alzheimer's disease: a multicenter study protocol for a randomized controlled trial

Front Neurol. 2024 Apr 10:15:1356073. doi: 10.3389/fneur.2024.1356073. eCollection 2024.

Authors

TaeYeong Kim¹, Dong Woo Kang², Jhosedyn Carolaym Salazar Fajardo¹, Hanna Jang¹, Yoo Hyun Um³, Sunghwan Kim⁴, Sheng-Min Wang⁴, Donghyeon Kim¹, Hyun Kook Lim⁴

Affiliations

¹ Research Institute, Neurophet Inc., Seoul, Republic of Korea.
² Department of Psychiatry, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
³ Department of Psychiatry, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
⁴ Department of Psychiatry, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.

Abstract

Introduction: Transcranial direct current stimulation (tDCS) may effectively preserve and improve cognitive function in patients with mild cognitive impairment (MCI). Research has shown that Individual brain characteristics can influence the effects of tDCS. Computer three-dimensional brain modeling based on magnetic resonance imaging (MRI) has been suggested as an alternative for determining the most accurate tDCS electrode position based on the patients' individual brain characteristics to enhance tDCS effects. Therefore, this study aims to determine the feasibility and safety of applying tDCS treatment using optimized and personalized tDCS electrode positions in patients with Alzheimer's disease (AD)-induced MCI using computer modeling and compare the results with those of a sham group to improve cognitive function.

Method: A prospective active-sham group feasibility study was set to recruit 40 participants, who will be randomized into Optimized-tDCS and Sham-tDCS groups. The parameters for tDCS will be 2 mA (disk electrodes R = 1.5 cm) for 30 min during two sets of 15 sessions (2 weeks of resting period in between), using two electrodes in pairs. Using computer modeling, the tDCS electrode positions of each participant will be personalized. Outcome measurements are going to be obtained at three points: baseline, first post-test, and second post-test. The AD assessment scale-cognitive subscale (ADAS-Cog) and the Korean version of Mini-Mental State Examination (K-MMSE), together with other secondary outcomes and safety tests will be used.

Discussion: For the present study, we hypothesize that compared to a sham group, the optimized personalized tDCS application would be effective in improving the cognitive function of patients with AD-induced MCI and the participants would tolerate the tDCS intervention without any significant adverse effects.Clinical trial registration: https://cris.nih.go.kr, identifier [KCT0008918].

Keywords: brain modeling; cognitive function; mild cognitive impairment; non-invasive brain stimulation; transcranial direct current stimulation.

Grants and funding

The author(s) declare that financial support was received for the research, authorship, and/or publication of this article. This study is supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health and Welfare, Republic of Korea (grant number: HI22C0467).