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Trials
Published in: Trials 1/2024

Open Access 01-12-2024 | Parkinson's Disease | Study protocol

Transcranial alternating current stimulation improves quality of life in Parkinson’s disease: study protocol for a randomized, double-blind, controlled trial

Authors: Hong-yu Zhang, Ting-ting Hou, Zhao-hui Jin, Tian Zhang, Yi-heng Wang, Zi-hao Cheng, Yong-hong Liu, Jin-ping Fang, Hong-jiao Yan, Yi Zhen, Xia An, Jia Du, Ke-ke Chen, Zhen-zhen Li, Qing Li, Qi-ping Wen, Bo-yan Fang

Published in: Trials | Issue 1/2024

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Abstract

Background

The neural cells in the brains of patients with Parkinson’s disease (PWP) display aberrant synchronized oscillatory activity within the beta frequency range. Additionally, enhanced gamma oscillations may serve as a compensatory mechanism for motor inhibition mediated by beta activity and also reinstate plasticity in the primary motor cortex affected by Parkinson’s disease. Transcranial alternating current stimulation (tACS) can synchronize endogenous oscillations with exogenous rhythms, thereby modulating cortical activity. The objective of this study is to investigate whether the addition of tACS to multidisciplinary intensive rehabilitation treatment (MIRT) can improve symptoms of PWP so as to enhance the quality of life in individuals with Parkinson’s disease based on the central-peripheral-central theory.

Methods

The present study was a randomized, double-blind trial that enrolled 60 individuals with Parkinson’s disease aged between 45 and 70 years, who had Hoehn-Yahr scale scores ranging from 1 to 3. Participants were randomly assigned in a 1:1 ratio to either the tACS + MIRT group or the sham-tACS + MIRT group. The trial consisted of a two-week double-blind treatment period followed by a 24-week follow-up period, resulting in a total duration of twenty-six weeks. The primary outcome measured the change in PDQ-39 scores from baseline (T0) to 4 weeks (T2), 12 weeks (T3), and 24 weeks (T4) after completion of the intervention. The secondary outcome assessed changes in MDS-UPDRS III scores at T0, the end of intervention (T1), T2, T3, and T4. Additional clinical assessments and mechanistic studies were conducted as tertiary outcomes.

Discussion

The objective of this study is to demonstrate that tACS can enhance overall functionality and improve quality of life in PWP, based on the framework of MIRT. Additionally, it seeks to establish a potential correlation between these therapeutic effects and neuroplasticity alterations in relevant brain regions. The efficacy of tACS will be assessed during the follow-up period in order to optimize neuroplasticity and enhance its potential impact on rehabilitation efficiency for PWP.

Trial registration

Chinese Clinical Trial Registry ChiCTR2300071969. Registered on 30 May 2023.
Appendix
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Metadata
Title
Transcranial alternating current stimulation improves quality of life in Parkinson’s disease: study protocol for a randomized, double-blind, controlled trial
Authors
Hong-yu Zhang
Ting-ting Hou
Zhao-hui Jin
Tian Zhang
Yi-heng Wang
Zi-hao Cheng
Yong-hong Liu
Jin-ping Fang
Hong-jiao Yan
Yi Zhen
Xia An
Jia Du
Ke-ke Chen
Zhen-zhen Li
Qing Li
Qi-ping Wen
Bo-yan Fang
Publication date
01-12-2024
Publisher
BioMed Central
Published in
Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-024-08045-5

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