Somato-cognitive coordination therapy using VR for advanced severe Parkinson’s disease

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  Late Breaking Symposium Room 8 Hall D1 / LB-2 May 30, 2024, 15:30 17:30 Somato-cognitive coordination therapy using VR for advanced severe Parkinson’s disease 1) Center for Community-Based Healthcare Research and Education, Shimane University Faculty of Medicine, Izumo, Japan 2) Department of Neurology and Clinical Rehabilitation, mediVR Rehabilitation Center Masahiko Hara, MD, PhD 1)2) Slide Data Download (Free to distribute & reuse)

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  The Japanese Society of Neurology COI Disclosure Presenter：Masahiko Hara In relation to my presentation, I disclose the following potential COI ① ② ③ ④ ⑤ ⑥ ⑦ ⑧ Consultant/Officer: Yes (mediVR Inc.) Stock ownership/Benefits: Yes (mediVR Inc.) Patent royalties: No Lecture fees: No Manuscript fees: No Research funding: No Scholarships/Endowments: No Other: No

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  1. Background Advanced severe Parkinson's disease (PD), classified as Hoehn–Yahr severity classification (H&Y) stage IV or V disease, is particularly debilitating. It often leads to severe gait and upper limb dysfunction, substantially diminishing the patient's quality of life.1-2) 1) Shulman LM, et al. Mov. Disord. 2008;23:790-796. 2) Debû B, et al. Curr. Neurol. Neurosci. Rep. 2018;18:23. Recent technological advancements have led to the exploration of additional rehabilitation approaches, including virtual reality (VR). Especially, the therapy known as "somato-cognitive coordination therapy (SCCT)" aimed at improving motor coordination disorders, is attracting attention from physicians across various neurological diseases.3-4) 3) Yamaguchi T, et al. J. Neuroeng. Rehabil. 2022;19:92. 4) Takimoto K, et al. BMJ. Case Rep. 2021;14:e242287.

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  1. Background Penfield’s Homunculus (1948) Integrate–isolate model 5) Woman in 30s 10M after infarction 20min SCCT BBT 28⇒40 5) Gordon, et al. A somato-cognitive action network (SCAN) alternates with effector regions in motor cortex. Nature 2023;617:351-359. SCCT is a treatment that visualizes and unravels the tangle of the SCAN and provides interventions to untangle it.

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  2. Methods 【Objectives】 To investigate the feasibility of SCCT in patients with severe PD. 【Study Design】 The single-arm, multicenter, prospective 【Study Patients】 Hoehn–Yahr stage IV or V disease (n=20) at 3 institutions 【Intervention】 SCCT (mediVR KAGURA🄬, mediVR, Inc., Toyonaka, Japan) ⇒ FDA&PMDA registered Reach alternately in a sitting position 20 min per session thrice weekly for 3 months (amounting to approximately 12 h of intervention)

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  2. Methods 【Endpoints】 Primary: The safety (absence of adverse events) and tolerability (the ability complete the prescribed therapy sessions without discontinuation) Secondary: Timed Up & Go test (TUG) Simple test for evaluating hand function (STEF) UPDRS Part III、and Functional Independence Measure (FIM) “Through seated exercises” SCCT mimics walking6-7) 6) Hara M. CHIRYO (Japanese Article). 2023;105:1270-1275. 7) Omon K, et al. Prog Rehabil Med 2019;4:20190011. Seated Reaching Walking Time changes in body axis Before After 【Statistical analysis】 Parametric (mean±SD, and paired-t test) 6) CHIRYO (Japanese Article). 2023;105:1270-1275. 【Ethical 】 The study protocol complied with the principles of the Declaration of Helsinki and was approved by the Central Institutional Ethics Committee of the Japan Society of Clinical Research (UMIN CTR: UMIN000041770).

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  3. Results…Patient Characteristics ( J Parkinsons Dis. 2024 Epub ahead of print. PMID: 38607764 ) Seventeen patients completed the 3-month trial successfully. (3 dropped out owing to relocation and health complications such as pneumonia) Parameters Age, years Male Duration from diagnosis, years Hoehn–Yahr severity classification Stage IV Stage V Medications at baseline Levodopa + decarboxylase inhibitor Levodopa equivalent dose (mg) Dopamine agonist COMT inhibitor MAO-B inhibitor Adenosine A2A receptor antagonist Amantadine Zonisamide Droxidopa Device aided therapy Total (n=17) 76±9 11 (64.7%) 11±6 13 (76.5%) 4 (23.5%) 17 (100%) 512±238 11 (64.7%) 6 (35.3%) 2 (11.8%) 5 (29.4%) 3 (17.7%) 8 (47.1%) 3 (17.7%) 0 (0.0%)

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  3. Results …Endpoints ( J Parkinsons Dis. 2024 Epub ahead of print. PMID: 38607764 ) There were no statistically significant changes in medication usage (ex, LED from 512±238 mg at baseline and 518±243 mg at 3 months, p=0.543) Primary Endpoints 1. Safety (absence of adverse events) 100% 2. Tolerability (the ability complete the prescribed therapy sessions) 100% Secondary Endpoints TUG reduced by 8.9 seconds STEF improved by 9.6 points Baseline Baseline At 3-month At 3-month

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  4. Discussion Concepts of mediVR KAGURA🄬-guided Somato-Cognitive Coordination Therapy We have been aware of the abnormalities in SCAN since 2016. Entangled‐SCAN can be provoked and improved in the following specific situations (backed by 18 patented technologies) (1) Invisible body part; do not use avatar (AR/MR could not produce) (2) Point estimation (aligning a controller with a specific coordinate) ⇒Deep muscles can be stimulated 8) 8) Kitano M, et al. Analysis of muscle thickness changes in the lateral abdominal muscles during exercise using virtual reality. J Phys Ther Sci. 2024. in press. (3) Multi-sensory feedback These aspects greatly enhance the brain's plasticity Single SCCT approach resulted in the improvements of ① Walking ability ② Hand function （③Speech function9）⇒ May 31 Fri 17:15-18:35 5) Gordon, et al. Nature 2023;617:351-359. MSP-01-4 9) Hara M, et al. Precision Medicine (Japanese Article). 2023;6:1031-1034.

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  5. Conclusion SCCT emerges as feasible and well-tolerated intervention in advanced severe PD. It also has the potential to improve gait and upper limb functions in these patients.10) Due to a preliminary nature of the study, RCT with larger sample size is required to validate and augment our study’s findings. For more information regarding SCCT 10) J Parkinsons Dis. 2024 Epub ahead of print. PMID: 38607764 Exhibition Hall E mediVR, Inc.