Dose-Response Transcranial Electrical Stimulation Study Design: A Well-Controlled Adaptive Seamless Bayesian Method to Illuminate Negative Valence Role in Tinnitus Perception
The use of transcranial Electrical Stimulation (tES) in the modulation of cognitive brain functions to improve neuropsychiatric conditions has extensively increased over the decades. tES techniques have also raised new challenges associated with study design, stimulation protocol, functional specifi...
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| Format: | Article |
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Frontiers Media S.A.
2022-05-01
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| Series: | Frontiers in Human Neuroscience |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fnhum.2022.811550/full |
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| author | Iman Ghodratitoostani Oilson A. Gonzatto Zahra Vaziri Alexandre C. B. Delbem Bahador Makkiabadi Bahador Makkiabadi Abhishek Datta Chris Thomas Miguel A. Hyppolito Antonio C. D. Santos Francisco Louzada João Pereira Leite |
| author_facet | Iman Ghodratitoostani Oilson A. Gonzatto Zahra Vaziri Alexandre C. B. Delbem Bahador Makkiabadi Bahador Makkiabadi Abhishek Datta Chris Thomas Miguel A. Hyppolito Antonio C. D. Santos Francisco Louzada João Pereira Leite |
| author_sort | Iman Ghodratitoostani |
| collection | DOAJ |
| description | The use of transcranial Electrical Stimulation (tES) in the modulation of cognitive brain functions to improve neuropsychiatric conditions has extensively increased over the decades. tES techniques have also raised new challenges associated with study design, stimulation protocol, functional specificity, and dose-response relationship. In this paper, we addressed challenges through the emerging methodology to investigate the dose-response relationship of High Definition-transcranial Direct Current Stimulation (HD tDCS), identifying the role of negative valence in tinnitus perception. In light of the neurofunctional testable framework and tES application, hypotheses were formulated to measure clinical and surrogate endpoints. We posited that conscious pairing adequately pleasant stimuli with tinnitus perception results in correction of the loudness misperception and would be reinforced by concurrent active HD-tDCS on the left Dorsolateral Prefrontal Cortex (dlPFC). The dose-response relationship between HD-tDCS specificity and the loudness perception is also modeled. We conducted a double-blind, randomized crossover pilot study with six recruited tinnitus patients. Accrued data was utilized to design a well-controlled adaptive seamless Bayesian dose-response study. The sample size (n = 47, for 90% power and 95% confidence) and optimum interims were anticipated for adaptive decision-making about efficacy, safety, and single session dose parameters. Furthermore, preliminary pilot study results were sufficient to show a significant difference (90% power, 99% confidence) within the longitudinally detected self-report tinnitus loudness between before and under positive emotion induction. This study demonstrated a research methodology used to improve emotion regulation in tinnitus patients. In the projected method, positive emotion induction is essential for promoting functional targeting under HD-tDCS anatomical specificity to indicate the efficacy and facilitate the dose-finding process. The continuous updating of prior knowledge about efficacy and dose during the exploratory stage adapts the anticipated dose-response model. Consequently, the effective dose range to make superiority neuromodulation in correcting loudness misperception of tinnitus will be redefined. Highly effective dose adapts the study to a standard randomized trial and transforms it into the confirmatory stage in which active HD-tDCS protocol is compared with a sham trial (placebo-like). Establishing the HD-tDCS intervention protocols relying on this novel method provides reliable evidence for regulatory agencies to approve or reject the efficacy and safety. Furthermore, this paper supports a technical report for designing multimodality data-driven complementary investigations in emotion regulation, including EEG-driven neuro markers, Stroop-driven attention biases, and neuroimaging-driven brain network dynamics. |
| first_indexed | 2024-12-12T09:15:06Z |
| format | Article |
| id | doaj.art-2eafd7a44b264633978571a34d3b5c05 |
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| last_indexed | 2024-12-12T09:15:06Z |
| publishDate | 2022-05-01 |
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| series | Frontiers in Human Neuroscience |
| spelling | doaj.art-2eafd7a44b264633978571a34d3b5c052022-12-22T00:29:24ZengFrontiers Media S.A.Frontiers in Human Neuroscience1662-51612022-05-011610.3389/fnhum.2022.811550811550Dose-Response Transcranial Electrical Stimulation Study Design: A Well-Controlled Adaptive Seamless Bayesian Method to Illuminate Negative Valence Role in Tinnitus PerceptionIman Ghodratitoostani0Oilson A. Gonzatto1Zahra Vaziri2Alexandre C. B. Delbem3Bahador Makkiabadi4Bahador Makkiabadi5Abhishek Datta6Chris Thomas7Miguel A. Hyppolito8Antonio C. D. Santos9Francisco Louzada10João Pereira Leite11Neurocognitive Engineering Laboratory, Center for Engineering Applied to Health, Institute of Mathematics and Computer Science, University of São Paulo, São Carlos, BrazilInstitute of Mathematics and Computer Science, University of São Paulo, São Carlos, BrazilDepartment of Neuroscience and Behavior, Faculty of Medicine of Ribeirão Preto, University of São Paulo, Ribeirao Preto, BrazilNeurocognitive Engineering Laboratory, Center for Engineering Applied to Health, Institute of Mathematics and Computer Science, University of São Paulo, São Carlos, BrazilResearch Center for Biomedical Technologies and Robotics, Institute for Advanced Medical Technologies, Tehran, IranDepartment of Medical Physics and Biomedical Engineering, School of Medicine, Tehran University of Medical Sciences, Tehran, IranSoterix Medical, New York, NY, United StatesSoterix Medical, New York, NY, United StatesDepartment of Ophthalmology, Otorhinolaryngology, Head and Neck Surgery, Ribeirão Preto Medical School, University of São Paulo, Ribeirao Preto, BrazilDepartment of Neuroscience and Behavior, Faculty of Medicine of Ribeirão Preto, University of São Paulo, Ribeirao Preto, BrazilInstitute of Mathematics and Computer Science, University of São Paulo, São Carlos, BrazilDepartment of Neuroscience and Behavior, Faculty of Medicine of Ribeirão Preto, University of São Paulo, Ribeirao Preto, BrazilThe use of transcranial Electrical Stimulation (tES) in the modulation of cognitive brain functions to improve neuropsychiatric conditions has extensively increased over the decades. tES techniques have also raised new challenges associated with study design, stimulation protocol, functional specificity, and dose-response relationship. In this paper, we addressed challenges through the emerging methodology to investigate the dose-response relationship of High Definition-transcranial Direct Current Stimulation (HD tDCS), identifying the role of negative valence in tinnitus perception. In light of the neurofunctional testable framework and tES application, hypotheses were formulated to measure clinical and surrogate endpoints. We posited that conscious pairing adequately pleasant stimuli with tinnitus perception results in correction of the loudness misperception and would be reinforced by concurrent active HD-tDCS on the left Dorsolateral Prefrontal Cortex (dlPFC). The dose-response relationship between HD-tDCS specificity and the loudness perception is also modeled. We conducted a double-blind, randomized crossover pilot study with six recruited tinnitus patients. Accrued data was utilized to design a well-controlled adaptive seamless Bayesian dose-response study. The sample size (n = 47, for 90% power and 95% confidence) and optimum interims were anticipated for adaptive decision-making about efficacy, safety, and single session dose parameters. Furthermore, preliminary pilot study results were sufficient to show a significant difference (90% power, 99% confidence) within the longitudinally detected self-report tinnitus loudness between before and under positive emotion induction. This study demonstrated a research methodology used to improve emotion regulation in tinnitus patients. In the projected method, positive emotion induction is essential for promoting functional targeting under HD-tDCS anatomical specificity to indicate the efficacy and facilitate the dose-finding process. The continuous updating of prior knowledge about efficacy and dose during the exploratory stage adapts the anticipated dose-response model. Consequently, the effective dose range to make superiority neuromodulation in correcting loudness misperception of tinnitus will be redefined. Highly effective dose adapts the study to a standard randomized trial and transforms it into the confirmatory stage in which active HD-tDCS protocol is compared with a sham trial (placebo-like). Establishing the HD-tDCS intervention protocols relying on this novel method provides reliable evidence for regulatory agencies to approve or reject the efficacy and safety. Furthermore, this paper supports a technical report for designing multimodality data-driven complementary investigations in emotion regulation, including EEG-driven neuro markers, Stroop-driven attention biases, and neuroimaging-driven brain network dynamics.https://www.frontiersin.org/articles/10.3389/fnhum.2022.811550/fullevaluative conditional learningneurofunctional tinnitus modelpositive emotion inductionhigh definition-transcranial direct current stimulationloudness misperception correctionadaptive seamless study design |
| spellingShingle | Iman Ghodratitoostani Oilson A. Gonzatto Zahra Vaziri Alexandre C. B. Delbem Bahador Makkiabadi Bahador Makkiabadi Abhishek Datta Chris Thomas Miguel A. Hyppolito Antonio C. D. Santos Francisco Louzada João Pereira Leite Dose-Response Transcranial Electrical Stimulation Study Design: A Well-Controlled Adaptive Seamless Bayesian Method to Illuminate Negative Valence Role in Tinnitus Perception Frontiers in Human Neuroscience evaluative conditional learning neurofunctional tinnitus model positive emotion induction high definition-transcranial direct current stimulation loudness misperception correction adaptive seamless study design |
| title | Dose-Response Transcranial Electrical Stimulation Study Design: A Well-Controlled Adaptive Seamless Bayesian Method to Illuminate Negative Valence Role in Tinnitus Perception |
| title_full | Dose-Response Transcranial Electrical Stimulation Study Design: A Well-Controlled Adaptive Seamless Bayesian Method to Illuminate Negative Valence Role in Tinnitus Perception |
| title_fullStr | Dose-Response Transcranial Electrical Stimulation Study Design: A Well-Controlled Adaptive Seamless Bayesian Method to Illuminate Negative Valence Role in Tinnitus Perception |
| title_full_unstemmed | Dose-Response Transcranial Electrical Stimulation Study Design: A Well-Controlled Adaptive Seamless Bayesian Method to Illuminate Negative Valence Role in Tinnitus Perception |
| title_short | Dose-Response Transcranial Electrical Stimulation Study Design: A Well-Controlled Adaptive Seamless Bayesian Method to Illuminate Negative Valence Role in Tinnitus Perception |
| title_sort | dose response transcranial electrical stimulation study design a well controlled adaptive seamless bayesian method to illuminate negative valence role in tinnitus perception |
| topic | evaluative conditional learning neurofunctional tinnitus model positive emotion induction high definition-transcranial direct current stimulation loudness misperception correction adaptive seamless study design |
| url | https://www.frontiersin.org/articles/10.3389/fnhum.2022.811550/full |
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