scholarly journals A Mindfulness-Based Brain-Computer Interface Augmenting Mandala Coloring for Depression: Protocol for a Single-Case Experimental Design (Preprint)

10.2196/20819 ◽  
2020 ◽  
Author(s):  
Claudia Daudén Roquet ◽  
Corina Sas
10.2196/20979 ◽  
2020 ◽  
Vol 9 (9) ◽  
pp. e20979
Author(s):  
Negin Hesam-Shariati ◽  
Toby Newton-John ◽  
Avinash K Singh ◽  
Carlos A Tirado Cortes ◽  
Tien-Thong Nguyen Do ◽  
...  

Background Neuropathic pain is a debilitating secondary condition for many individuals with spinal cord injury. Spinal cord injury neuropathic pain often is poorly responsive to existing pharmacological and nonpharmacological treatments. A growing body of evidence supports the potential for brain-computer interface systems to reduce spinal cord injury neuropathic pain via electroencephalographic neurofeedback. However, further studies are needed to provide more definitive evidence regarding the effectiveness of this intervention. Objective The primary objective of this study is to evaluate the effectiveness of a multiday course of a brain-computer interface neuromodulative intervention in a gaming environment to provide pain relief for individuals with neuropathic pain following spinal cord injury. Methods We have developed a novel brain-computer interface-based neuromodulative intervention for spinal cord injury neuropathic pain. Our brain-computer interface neuromodulative treatment includes an interactive gaming interface, and a neuromodulation protocol targeted to suppress theta (4-8 Hz) and high beta (20-30 Hz) frequency powers, and enhance alpha (9-12 Hz) power. We will use a single-case experimental design with multiple baselines to examine the effectiveness of our self-developed brain-computer interface neuromodulative intervention for the treatment of spinal cord injury neuropathic pain. We will recruit 3 participants with spinal cord injury neuropathic pain. Each participant will be randomly allocated to a different baseline phase (ie, 7, 10, or 14 days), which will then be followed by 20 sessions of a 30-minute brain-computer interface neuromodulative intervention over a 4-week period. The visual analog scale assessing average pain intensity will serve as the primary outcome measure. We will also assess pain interference as a secondary outcome domain. Generalization measures will assess quality of life, sleep quality, and anxiety and depressive symptoms, as well as resting-state electroencephalography and thalamic γ-aminobutyric acid concentration. Results This study was approved by the Human Research Committees of the University of New South Wales in July 2019 and the University of Technology Sydney in January 2020. We plan to begin the trial in October 2020 and expect to publish the results by the end of 2021. Conclusions This clinical trial using single-case experimental design methodology has been designed to evaluate the effectiveness of a novel brain-computer interface neuromodulative treatment for people with neuropathic pain after spinal cord injury. Single-case experimental designs are considered a viable alternative approach to randomized clinical trials to identify evidence-based practices in the field of technology-based health interventions when recruitment of large samples is not feasible. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000556943; https://bit.ly/2RY1jRx International Registered Report Identifier (IRRID) PRR1-10.2196/20979


2020 ◽  
Author(s):  
Negin Hesam-Shariati ◽  
Toby Newton-John ◽  
Avinash K Singh ◽  
Carlos A Tirado Cortes ◽  
Tien-Thong Nguyen Do ◽  
...  

BACKGROUND Neuropathic pain is a debilitating secondary condition for many individuals with spinal cord injury. Spinal cord injury neuropathic pain often is poorly responsive to existing pharmacological and nonpharmacological treatments. A growing body of evidence supports the potential for brain-computer interface systems to reduce spinal cord injury neuropathic pain via electroencephalographic neurofeedback. However, further studies are needed to provide more definitive evidence regarding the effectiveness of this intervention. OBJECTIVE The primary objective of this study is to evaluate the effectiveness of a multiday course of a brain-computer interface neuromodulative intervention in a gaming environment to provide pain relief for individuals with neuropathic pain following spinal cord injury. METHODS We have developed a novel brain-computer interface-based neuromodulative intervention for spinal cord injury neuropathic pain. Our brain-computer interface neuromodulative treatment includes an interactive gaming interface, and a neuromodulation protocol targeted to suppress theta (4-8 Hz) and high beta (20-30 Hz) frequency powers, and enhance alpha (9-12 Hz) power. We will use a single-case experimental design with multiple baselines to examine the effectiveness of our self-developed brain-computer interface neuromodulative intervention for the treatment of spinal cord injury neuropathic pain. We will recruit 3 participants with spinal cord injury neuropathic pain. Each participant will be randomly allocated to a different baseline phase (ie, 7, 10, or 14 days), which will then be followed by 20 sessions of a 30-minute brain-computer interface neuromodulative intervention over a 4-week period. The visual analog scale assessing average pain intensity will serve as the primary outcome measure. We will also assess pain interference as a secondary outcome domain. Generalization measures will assess quality of life, sleep quality, and anxiety and depressive symptoms, as well as resting-state electroencephalography and thalamic γ-aminobutyric acid concentration. RESULTS This study was approved by the Human Research Committees of the University of New South Wales in July 2019 and the University of Technology Sydney in January 2020. We plan to begin the trial in October 2020 and expect to publish the results by the end of 2021. CONCLUSIONS This clinical trial using single-case experimental design methodology has been designed to evaluate the effectiveness of a novel brain-computer interface neuromodulative treatment for people with neuropathic pain after spinal cord injury. Single-case experimental designs are considered a viable alternative approach to randomized clinical trials to identify evidence-based practices in the field of technology-based health interventions when recruitment of large samples is not feasible. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000556943; https://bit.ly/2RY1jRx INTERNATIONAL REGISTERED REPORT PRR1-10.2196/20979


2018 ◽  
Vol 21 ◽  
Author(s):  
Leandro da Silva-Sauer ◽  
Luis Valero-Aguayo ◽  
Francisco Velasco-Álvarez ◽  
Álvaro Fernández-Rodríguez ◽  
Ricardo Ron-Angevin

AbstractThis study aimed to propose an adapted feedback using a psychological learning technique based on Skinner’s shaping method to help the users to modulate two cognitive tasks (right-hand motor imagination and relaxed state) and improve better control in a Brain-Computer Interface. In the first experiment, a comparative study between performance in standard feedback (N = 9) and shaping method (N = 10) was conducted. The NASA Task Load Index questionnaire was applied to measure the user’s workload. In the second experiment, a single case study was performed (N = 5) to verify the continuous learning by the shaping method. The first experiment showed significant interaction effect between sessions and group (F(1, 17) = 5.565; p = .031) which the shaping paradigm was applied. A second interaction effect demonstrates a higher performance increase in the relax state task with shaping procedure (F(1, 17) = 5. 038; p = .038). In NASA-TXL an interaction effect was obtained between the group and the cognitive task in Mental Demand (F(1, 17) = 6, 809; p = .018), Performance (F(1, 17) = 5, 725; p = .029), and Frustration (F(1, 17) = 9, 735; p = .006), no significance was found in Effort. In the second experiment, a trial-by-trial analysis shows an ascendant trend learning curve for the cognitive task with the lowest initial acquisition (relax state). The results suggest the effectiveness of the shaping procedure to modulate brain rhythms, improving mainly the cognitive task with greater initial difficulty and provide better interaction perception.


2013 ◽  
Vol 133 (3) ◽  
pp. 635-641
Author(s):  
Genzo Naito ◽  
Lui Yoshida ◽  
Takashi Numata ◽  
Yutaro Ogawa ◽  
Kiyoshi Kotani ◽  
...  

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