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Phase I Safety Trial: Extended Daily Peripheral Sensory Stimulation Using a Wrist-Worn Vibrator in Stroke Survivors

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Abstract

Peripheral sensory stimulation augments post-stroke upper extremity rehabilitation outcomes. Most sensory stimulations interfere with natural hand tasks and the stimulation duration is limited. We developed TheraBracelet, low-level random-frequency vibration applied via a wristwatch, to enable stimulation during hand tasks and potentially extend stimulation durations. To determine safety of prolonged exposure to TheraBracelet. Single-site double-blind crossover randomized controlled trial. Chronic stroke survivors were instructed to wear a device on the affected wrist for > 8 h/day everyday for 2 months while coming to the laboratory weekly for evaluations, with a 2-week break between each month. The device applied vibration at 60% and 1% of the sensory threshold for the real and sham month, respectively. The order of the real and sham months was randomized/balanced. Adverse events (AEs) were assessed weekly, including worsening of hand sensation, dexterity, grip strength, pain, or spasticity and occurrence of skin irritation or swelling. Device-related AE rates were compared between the real and sham month. Twenty-five participants completed the study. Six participants (24%) experienced mild AEs involving worsened sensory scores that may be related to the intervention with reasonable possibility. Two experienced them in the real stimulation month only, 3 in the sham month only, and 1 in both months. Therefore, less participants experienced device-related AEs in the real than sham month. Daily stimulation using the device for a month is safe for chronic stroke survivors. Future studies examining the efficacy of pairing TheraBracelet with therapy for increasing neurorehabilitation outcomes are a logical next step. Trial registration: NCT03318341

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Acknowledgments

The authors would like to thank the Data and Safety Monitoring Board members, Drs. Robert Adams, Craig Velozo, and Caitlyn Meinzer.

Funding

This study was possible through funding from the NIH/NICHD Small Business Technology Transfer (STTR) R41HD090792 awarded to TheraBracelet Inc. with a subcontract to the Medical University of South Carolina (PI: Seo), and NIH/NIGMS P20GM109040 COBRE for Stroke Recovery (PI: Kautz).

Author information

Authors and Affiliations

  1. Division of Occupational Therapy, Department of Health Professions, Department of Health Sciences and Research, Medical University of South Carolina (MUSC), Charleston, SC, USA

    Na Jin Seo

  2. TheraBracelet Inc., Louisville, KY, USA

    Leah R. Enders

  3. Department of Health Sciences and Research, MUSC, Charleston, SC, USA

    Andrew Fortune

  4. Division of Occupational Therapy, Department of Health Professions, MUSC, Charleston, SC, USA

    Shannon Cain

  5. Department of Health Sciences and Research, MUSC, Charleston, SC, USA

    Amanda A. Vatinno & Wuwei Feng

  6. Department of Health Professions, MUSC, Charleston, SC, USA

    Eli Schuster

  7. Department of Public Health Sciences, MUSC, Charleston, SC, USA

    Viswanathan Ramakrishnan

  8. Department of Neurology, Duke University Medical Center, Durham, NC, USA

    Wuwei Feng

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  1. Na Jin Seo
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Corresponding author

Correspondence to Na Jin Seo.

Ethics declarations

Ethical Approval

All procedures performed in the study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

Conflict of Interest

N.J. Seo and L.R. Enders are inventors of a patent regarding the investigated sensory stimulation. Seo has no part in the company that sponsored this trial. Enders is a scientist in the company that sponsored this trial. The other authors report no conflicts of interest.

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Seo, N.J., Enders, L.R., Fortune, A. et al. Phase I Safety Trial: Extended Daily Peripheral Sensory Stimulation Using a Wrist-Worn Vibrator in Stroke Survivors. Transl. Stroke Res. 11, 204–213 (2020). https://doi.org/10.1007/s12975-019-00724-9

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